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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Intensity Modulated Accelerated Partial Breast Irradiation in Treating Older Patients with Hormone Responsive Stage 0-I Breast Cancer before Surgery

    Protocol: OSU-13282

    Eligibility:

    Inclusion Criteria:

    COHORT I:

    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    Patient must be > 18 years

    The patient must have clinical node negative, stage I breast cancer

    The surgical treatment must be intended to be a lumpectomy

    The biopsy site must have been demarcated by a clip(s)

    Gross disease must be unifocal on mammogram (mammo)/magnetic resonance imaging (MRI) imaging

    Patient must be able to tolerate lying in the prone position with arms extended forward

    Must be able to tolerate MRI scan with contrast

    COHORT II: The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines

    COHORT II: Patient must be >= 60 years

    COHORT II: Core biopsy demonstrating breast cancer and receptors that are estrogen receptor (ER) or progesterone receptor (PR) positive

    COHORT II: Core tissue must have human epidermal growth factor receptor 2 (HER 2) testing

    COHORT II: The patient must have clinical node negative, stage I breast cancer

    COHORT II: The surgical treatment must be intended to be a lumpectomy

    COHORT II: The biopsy site must have been demarcated by a clip(s)

    COHORT II: Gross disease must be unifocal on Mammo/ MRI imaging

    COHORT II: Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy

    COHORT II: Patient must be able to tolerate lying in the prone position with arms extended forward

    COHORT II: Must be able to tolerate MRI scan with contrast

    COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months

    COHORT II: Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI

    COHORT II: Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin

    Exclusion Criteria:

    COHORT II:

    Age < 60 years

    Hormone unresponsive breast cancer

    T-2 (> 3.0 cm), T-3, stage III, or stage IV breast cancer

    N-1, N-2, or N-3 pathologic axillary nodes

    Mastectomy intended

    Unwilling to undergo anti-endocrine therapy

    Suspicious microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign

    Non-epithelial breast malignancies such as sarcoma or lymphoma

    Paget’s disease of the nipple

    Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimeters

    Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment

    Prior breast or thoracic radiation therapy (RT) for any condition

    Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements

    Principal Investigator: Julia White, MD

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  • open for enrollment

    Metformin Hydrochloride in Preventing Breast Cancer in Patients with Atypical Hyperplasia or In Situ Breast Cancer

    Protocol: ALLIANCE-A211102

    Eligibility:

    Inclusion Criteria:

    PRE-REGISTRATION-INCLUSION CRITERIA

    Must be at increased risk for breast cancer, defined as at least one of the following four criteria:

    Having had a prior biopsy demonstrating atypical hyperplasia, lobular carcinoma in situ (LCIS), or ductal carcinoma in situ (DCIS)

    A Gail Model Risk of >= 1.66% over 5 years

    A strong family history of breast and/or ovarian cancer which is defined as at least one of the following:

    • One first-degree relative with breast cancer before the age of 50 years
    • One first degree relative with bilateral breast cancer
    • Two or more first-degree relatives with breast cancer
    • One first degree relative and two or more second or third degree relatives with breast cancer
    • One first-degree relative with breast cancer and one or more relatives with ovarian cancer
    • Two second or third degree relatives with either breast cancer and one or more with ovarian cancer
    • One second or third degree relative with breast cancer and two or more with ovarian cancer
    • Three or more second or third degree relatives with breast cancer

    Known breast cancer (BRCA)1 or BRCA2 mutation carrier providing that the woman has

    • Met with a genetic counselor to review genetic testing results, and
    • Has been offered the opportunity to undergo prophylactic mastectomy and oophorectomy

    Pre-menopausal women as defined as four menstrual cycles within the last six months prior to pre-registration; women with less than 4 menses within 6 months prior to pre-registration, or women who have had a hysterectomy with ovaries intact will be considered premenopausal if follicle-stimulating hormone (FSH) level is < 20; women who are using hormonal contraceptives that cause amenorrhea (e.g. injectable and extended oral contraceptives, hormone containing contraceptive ring, or hormone containing intrauterine device) will be considered eligible if they had a minimum of 4 menstrual cycles within the last six months prior to starting on the contraceptive

    Digital mammogram within 180 days prior to pre-registration

    Mammograms must be read as not suspicious for breast cancer (American College of Rheumatology [ACR] class I-III); subjects with a class IV mammogram may be enrolled once they have been evaluated by a breast surgeon and there is no evidence of invasive malignancy

    Must be non-pregnant and non-lactating for at least one year prior to pre-registration

    If currently menstruating, subjects must use a reliable method of birth control

    Willing to provide RPFNA and blood samples for correlative research purposes

    Women with core biopsy or excisional biopsy containing DCIS, LCIS or atypia are eligible for this study

    Women eligible to take tamoxifen, must be offered tamoxifen prevention as part of their clinical care and have refused tamoxifen treatment

    REGISTRATION/RANDOMIZATION INCLUSION CRITERIA:

    Qualifying cytological atypia in RPFNA, Masood score of 14-17; the qualifying RPFNA (both breasts) must be send to Dr. Seewaldt's laboratory for cytological scoring and proteomic analysis; score results must be received from Dr. Seewaldt’s lab prior to patient registration/randomization; test must be done =< 30 days prior to registration/randomization; note: in subjects with DCIS, only the non-radiated breast can be aspirated

    Hemoglobin >= 9 g/dL

    Absolute neutrophil count (ANC) >= 1500/mm^3

    Platelet count >= 75,000/mm^3

    Creatinine =< 1.4 mg/dL

    Total bilirubin =< 3.0 mg/dL

    Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN)

    Alanine transaminase (ALT) =< 3 x ULN

    Negative pregnancy test done =< 7 days prior to registration/randomization, for women of childbearing potential only

    A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

    Exclusion Criteria:

    Other active malignancy =< 5 years prior to pre-registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment, i.e., other hormonal therapy, for their cancer

    Body mass index (BMI) < 25

    Receiving Warfarin

    Bilateral breast implants or autologous breast flap reconstruction

    Active diagnosis of alcoholism

    Contraindication to metformin prevention such as acute hypersensitivity or allergic reaction to metformin

    Currently receiving tamoxifen or raloxifene

    Administration of any investigational agent =< 30 days prior to pre-registration

    Previous radiation to both breasts

    Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Receiving pyrimethamine, cimetidine, rifampin or cephalexin

    Women who have a core biopsy or excisional biopsy containing invasive cancer

    Women who have taken metformin within the past 90 days

    Patients with hemoglobin a1c > 6.3 or who are being actively treated for diabetes

    Learn More
  • open for enrollment

    Curcumin in Reducing Inflammatory Changes in Breast Tissue in Obese Patients At High Risk for Breast Cancer

    Protocol: OSU-13034

    Eligibility:

    Inclusion Criteria:

    Subjects who are at high risk for breast cancer will be considered for participation in the study

    The ethnic and racial composition of the subject population will reflect the composition of subjects seeking care at The Ohio State University and James Cancer Hospital and Solove Research Institute; no special groups such as prisoners, children, the mentally disabled, or groups whose ability to give voluntary informed consent may be in question will be used for this study

    Definition of a high risk population:

    The study population will consist of women with a relative risk of developing breast cancer that is at least > 2 x that of the general population for their age group on the basis of any of the following:

    • Have a known genetic mutation associated with hereditary breast cancer (including breast cancer [BRCA]1, BRCA2, tumor protein [p]53, etc.)
    • One or more first degree relatives with breast cancer, with at least one under the age of 60
    • Two or more second degree relatives with breast cancer, with at least one under the age of 50
    • Prior biopsy diagnosing atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years
    • Have a Gail Risk Assessment (which is based on age, race, age of menarche, age of first live birth, number of first degree relatives with breast cancer, number of breast biopsies, and presence of high risk histology on any biopsies) that is considered high risk compared to the general population:

    *** 5 year Gail >= 1.7 or

    *** 10 year Gail >= 3.4%

    • Prior diagnosis of T1 or T2 breast cancer diagnosed within the last 10 years, without chemotherapy or antiestrogen therapy for > six months and >= 2 months since completion of radiation therapy, when applicable

    ELIGIBILITY CRITERIA FOR HIGH RISK PATIENTS FOR THE CLINICAL TRIAL

    Body mass index (BMI) between 30 - 40

    Must be > 1 year from pregnancy, lactation or chemotherapy

    Must have had a mammogram within the 12 months prior to study enrollment; mammograms must be read as not suspicious for breast cancer (American College of Radiology [ACR] class I-III); subjects with a class IV mammogram may be entered once they have had a negative biopsy

    Must be willing to undergo fine needle aspiration of breast adipose tissue at 0 and 3 months of the study

    Must be willing to have about 30 ml of blood (approximately 6 teaspoons) drawn at 0 and 3 months and about 5-10 ml of blood (approximately 1-2 teaspoons) at 1 and 2 months

    Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    Written signed informed consent; patients must be aware of their diagnosis and willingly consent after being informed of the investigational nature of the intervention, alternatives, potential benefits, side-effects, risks, and discomforts

    Exclusion Criteria:

    Concurrent malignancy or metastatic malignancy of any kind

    Ongoing chemotherapy, radiation therapy, or other cancer-related treatment

    History of a bleeding tendency or current use of Coumadin or other anticoagulants

    Current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (HIV) infection

    Pregnant or lactating women

    Concurrent use of hormonal contraception or hormone replacement therapy

    Concurrent use of immunosuppressant medications

    Concurrent use of antacids, hydrogen (H2) antagonists, proton-pump inhibitors, or medications known to inhibit or induce hepatic enzyme cytochrome P450 (CYP) 3A4

    Barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (FNA) sampling as determined by clinical examination and/or mammogram

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements

    Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with NEC

    Pregnant or nursing women

    Known sensitivity or allergy to turmeric spices or curry

    Dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis

    Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (NSAID)s or NSAID-containing products

    Subjects who cannot give an informed consent

    Principal Investigator: Steven K Clinton, MD, PhD

    Learn More
  • open for enrollment

    MRI and Mammography before Surgery in Patients with Stage I-II Breast Cancer

    Protocol: ALLIANCE-A011104

    Eligibility:

    Inclusion Criteria:

    Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0); diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded

    Patients must have either:

    Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry [IHC] staining) and HER-2 negative breast cancer OR

    ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors

    HER2 status will be determined per the 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines:

    • HER2 is considered positive if a) there is IHC 3+ staining or b) positive using either single probe in situ hybridization (ISH) or dual probe ISH
    • HER2 is considered negative if a) there is IHC 0 or 1+ staining or b) ISH negative using either single probe ISH or dual probe ISH

    No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS)

    No patients with bilateral breast cancer

    No patients with known deleterious mutations in breast cancer (BRCA) genes

    No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures

    No history of chemotherapy for cancer within 6 months prior to registration

    No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery

    Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram; women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial

    No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed can be enrolled

    Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):

    No history of untreatable claustrophobia

    No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)

    No history of sickle cell disease

    No contraindication to intravenous contrast administration

    No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance

    No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30

    mL/min/1.73 m^2 based on a serum creatinine level obtained within 7 days prior to registration

    Weight lower than that allowable by the MRI table

    No prior MRI of study breast within the 12 months prior to registration

    Non-pregnant and non-lactating; patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration; perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential

    Signed study-specific informed consent prior to registration

    Learn More
  • open for enrollment

    Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients with Stage II-III Breast Cancer Undergoing Surgery

    Protocol: ALLIANCE-A011106

    Eligibility:

    Inclusion Criteria:

    Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    Postmenopausal, verified by:

    Post bilateral surgical oophorectomy, or

    No spontaneous menses >= 1 year or

    No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards

    Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy

    Clinical T2-T4c, any N, M0 invasive breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node

    Primary tumor must be:

    Palpable

    Its largest tumor diameter is > 2.0 cm by physical examination or by radiological assessment

    Bi-dimensional measurement by tape, ruler or caliper technique must be provided

    • Note:

    *** Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible

    *** Patients with multi-focal breast cancer (defined as more than one lesion of invasive breast cancer in the same breast separated from the dominant breast lesion by less than 5 cm of radiologically normal breast tissue) are eligible; if the other lesions have been biopsied (biopsy not required) they must meet the estrogen receptor/human epidermal growth factor receptor 2 (ER/HER2) eligibility requirements; research biopsies and Ki67 assessment and radiological measures are to be performed on the dominant breast lesion

    Invasive breast cancer is estrogen receptor (ER) positive with an Allred score of 6, 7 or 8 by local institution standard protocol; if an Allred score is not reported on the diagnostic pathology report, ER positivity in > 66% cells is eligible; if ER positivity is =< 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred score to determine eligibility

    Invasive breast cancer is human epidermal growth factor receptor 2 (HER2) negative; a patient is considered to have HER2 negative breast cancer if one of the following if one of the following applies:

    0 or 1+ by immunohistochemistry (IHC) and in situ hybridization (ISH) not done

    0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2

    2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2

    Documentation of mammogram and ultrasound (including ductal carcinoma in situ [DCIS] and invasive cancer) of the diseased breast performed within 56 days prior to registration; mammogram for the unaffected contralateral breast is required within 12 months prior to registration

    Absolute neutrophil count (ANC) > 1,000/mm^3

    Platelet count > 100,000/mm^3

    Total bilirubin < 1.5 x upper limits of normal (ULN)

    Creatinine < 1.5 x ULN

    Serum alanine aminotransferase (ALT) < 2.5 x ULN

    Tissue acquisition: patient must agree to provide the required research biopsies at baseline, week 4 and at surgery for integral and integrated biomarker and correlative studies

    Exclusion Criteria:

    Premenopausal status

    Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d’orange without erythema)

    An excisional biopsy of this breast cancer

    Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration

    Tumor ER Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH > 2.0

    Surgical axillary staging procedure prior to study entry; Note: fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted

    Clinical or radiographic evidence of metastatic disease; metastatic workup is not required, but is recommended for patients with clinical stage III disease; Note: isolated ipsilateral supraclavicular node involvement is permitted

    Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion

    Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry

    History of invasive breast cancer or contralateral DCIS

    Principal Investigator: Bhuvaneswari Ramaswamy, MD

    Learn More
  • open for enrollment

    Hormone Therapy with or without Everolimus in Treating Patients with Breast Cancer

    Protocol: SWOG-S1207

    Eligibility:

    Inclusion Criteria:

    Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, for whom standard adjuvant endocrine therapy is planned; estrogen and progesterone receptor positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guidelines as either estrogen receptor (ER) or progesterone receptor (PR) >= 1% positive nuclear staining; HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using immunohistochemistry (IHC), in situ hybridization (ISH) or both; HER-2 is negative if a single test (or all tests) performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single probe or HER-2/chromosome enumeration probe [CEP] ratio < 2.0 with an average copy number < 4.0 signals per cell by dual probe); if HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+; HER-2 equivocal is not eligible

    Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed

    Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant

    Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants

    Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: the tumor with the highest recurrence score should be used)

    Patients must be high risk by belonging to one of the following risk groups:

    Completion of adjuvant chemotherapy and pathologically negative lymph nodes, and a tumor measuring >= 2 cm in greatest diameter, and an Oncotype DX® recurrence score > 25 (completed as standard of care); patients with micrometastases as the only nodal involvement (pN1mi) are eligible, and will be categorized as node-negative

    Completion of adjuvant chemotherapy, and pathologically 1-3 positive lymph nodes, and either an Oncotype DX® recurrence score > 25 (screened via S1007 or otherwise) or tumor tissue with pathological grade III following local practice; if Oncotype DX® is done, then RS must be > 25; if the test is not done, but the patient has grade III disease then the patient is eligible and Oncotype DX® does not need to be performed

    Completion of adjuvant chemotherapy and pathologically 4 or more positive lymph nodes

    Completion of neoadjuvant chemotherapy and 1 or more positive nodes pathologically determined prior to or after chemotherapy

    NOTE: in the lymph node positive groups, at least one metastasis >= 2.0 mm must be present; patients with micrometastases as the only nodal involvement (pN1mi) are eligible and will be categorized as node-negative

    Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins

    Patients who had breast-conserving surgery must have completed whole-breast radiation; use of regional nodal-basin radiation will be at the discretion of the investigator according to institutional guidelines

    Patients with >= 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy according to standard of care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients

    Patients must be registered no sooner than 21 days after completion of radiation therapy and must have recovered (=< grade 1) from any of the effects of radiation

    Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)

    For patients with 1-3 positive lymph nodes, sentinel-node biopsy alone is allowed provided that the patient completed either whole-breast or chest-wall radiation and the primary tumor is < 5 cm

    All patients with >= 4 positive lymph nodes must have completed ALND (with or without prior sentinel-node biopsy)

    Patients must have completed standard neoadjuvant or adjuvant taxane and/or anthracycline based chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 cycles (a cycle of weekly paclitaxel is considered 3 doses); patients must be registered within 42 weeks after the last dose of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer

    Patients must not be receiving or planning to receive trastuzumab; concurrent bisphosphonate therapy is allowed; patients must not have prior exposure to mechanistic target of rapamycin (serine/threonine kinase) (mTOR) inhibitors (rapamycin, everolimus, temsirolimus, deforolimus); patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study

    Absolute neutrophil count (ANC) >= 1,500/mL

    Hemoglobin >= 9 g/dL

    Platelet count >= 100,000/mL

    Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome)

    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 1.5 x institutional upper limit of normal (IULN)

    Alkaline phosphatase =< 1.5 x IULN

    Serum creatinine level =< IULN

    Fasting cholesterol =< 300 mg/dL and triglycerides =< 2.5 x IULN; patients may be on lipid-lowering agents to reach these values

    Patients must have a complete history and physical examination within 28 days prior to registration

    Patients must have a performance status of 0-2 by Zubrod criteria

    Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia

    Patients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)

    Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed

    Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline cluster of differentiation (CD)4 count is > 500 cells/mm³ AND not taking anti-retroviral therapy; patients with known hepatitis are not eligible unless there is a known negative hepatitis panel; patients must not have any known uncontrolled underlying pulmonary disease

    Patients must be able to take oral medications; patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

    Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette–Guérin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment

    Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or CYP3A4 inducers

    No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years

    Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy and barrier contraceptive devices; however, if at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures

    Patients must have pre-treatment blood and tissue specimens submitted for translational medicine as outlined; with patient consent, residuals will be banked for future research

    Patients (at National Cancer Institute [NCI] Community Oncology Research Program [NCORP] Institutions only) must be offered the opportunity to participate in the S1207-E01 Behavioral and Health Outcomes study (BAHO); NOTE: patients who have already started endocrine therapy are eligible for the BAHO study

    Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

    As a part of the Oncology Patient Enrollment Network (OPEN) registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

    Principal Investigator: William B Farrar, MD

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  • open for enrollment

    HSP90 Inhibitor AT13387 and Paclitaxel in Treating Patients with Advanced Triple Negative Breast Cancer

    Protocol: OSU-15149

    Eligibility:

    Inclusion Criteria:

    Patients must have histologically confirmed measurable or unmeasurable advanced or metastatic breast cancer for which standard curative measures do not exist or are no longer effective

    Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam

    Primary and/or metastatic breast tumor must be negative for over-expression of estrogen and progesterone receptors; patients with weak estrogen receptor and/or progesterone receptor expression (< 10% on immunohistochemistry [IHC]) will be eligible

    Primary and/or metastatic breast tumor must be negative for human epidermal growth factor receptor (HER-2/neu) over-expression based on IHC (0 or 1+, 2+ if fluorescence in-situ hybridization [FISH] test is negative) or FISH (HER2/copy number of centromere of chromosome 17 [CEP17] ratio < 2.0 or < 4 Her-2/neu signals per nucleus)

    Any number of prior therapies for metastatic breast cancer is allowed; patients with weakly estrogen receptor positive breast cancer who received any number of endocrine agents for metastatic breast cancer will also be eligible

    Prior taxane is allowed (as long as the patient is not experiencing grade > 1 neuropathy and had no history of disease progression on a taxane therapy within 6 months prior to study enrollment)

    Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

    Life expectancy of greater than 12 weeks

    Leukocytes >= 2,000/uL

    Absolute neutrophil count >= 1,500/uL

    Platelets >= 100,000/uL

    Total bilirubin within normal institutional limits

    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal (except for patients with liver metastases in whom AST/ALT can be < 5 x institutional upper limit of normal)

    Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min for patients with creatinine levels above institutional normal

    Left ventricular ejection fraction of > 50% on baseline echocardiography or multi-gated acquisition (MUGA) scan

    Corrected QT interval (QTc) of < 480 milliseconds

    Female subjects with child bearing potential must have a negative pregnancy test at screening; child bearing potential is defined as sexually active patients with menses less than 1 year prior to enrollment, < 65 years of age, have no history of oophorectomy or hysterectomy

    Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and 3 months after completion of study treatment administration; adequate contraception includes methods such as oral contraceptives, double barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

    Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study

    Patients who are receiving any other investigational agents within 4 weeks or 5 half-lives (whichever is later) prior to the first dose of the study regimen

    Prior radiation therapy within 2 weeks prior to the first dose of the study regimen

    Patients in whom prior treatment related toxicities have not recovered to grade 1 or less (except for alopecia)

    Recent initiation of bone modifying therapy with a bisphosphonate or denosumab unless it has been started more than 4 weeks prior to the first dose of the study regimen; patients who are already enrolled in this study can initiate bone modifying therapy after the first set of re-staging scans (>= 8 weeks from cycle 1, day 1)

    Prior therapy with AT13387 or another HSP90 inhibitor

    Patients with known brain metastases should be excluded from this clinical trial; however, patients with previously treated and stable brain metastases are eligible as long as they are no longer requiring steroids, completed radiation therapy more than 2 weeks prior to the first dose of study regimen and have no seizures or worsening neurologic symptoms

    History of grade 3-4 immediate hypersensitivity reaction to paclitaxel

    History of clinically significant allergic reactions attributed to compounds of similar chemical or biologic composition to AT13387 or paclitaxel

    The use of CYP2C8 and CYP3A4 inhibitors/inducers while not prohibited in this study, is discouraged whenever feasible; concurrent use of strong CYP2C8 and CYP3A4 inhibitors/inducers should be documented and the principal investigator (PI) of the study shall be notified prior to dosing; as part of the enrollment/informed consent procedures, the patients will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AT13387 and paclitaxel

    Patients who are human immunodeficiency virus (HIV) positive on highly active anti-retroviral therapy (HAART) will be excluded from the study

    Inability to understand and sign informed consent

    Any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient

    Principal Investigator: Robert Wesolowski, MD

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  • open for enrollment

    Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel with or without Carboplatin in Treating Patients with Triple-Negative Breast Cancer

    Protocol: NRG-BR003

    Eligibility:

    Inclusion Criteria:

    The patient must have signed and dated an institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines

    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination

    All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met:

    By pathologic evaluation, primary tumor must be pT1-3

    By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b

    If pN0, tumor must be > 3.0 cm

    The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative as follows:

    Immunohistochemistry (IHC) 0-1+; or

    IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or

    ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells

    The tumor must have been determined to be estrogen receptor (ER)-and progesterone receptor (PgR)-negative assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; patients with < 1% ER and PgR staining by IHC are considered negative

    The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy

    For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)

    For patients who undergo mastectomy, the margins must be free of residual gross tumor; (patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy [RT] of the chest wall will be administered)

    The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.

    Sentinel lymphadenectomy alone:

    • If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;
    • If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a and the patient has undergone breast conserving surgery (with planned breast radiotherapy), the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes

    Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or

    Axillary lymphadenectomy with or without SN isolation procedure

    The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days

    Absolute neutrophil count (ANC) must be >= 1200/mm^3

    Platelet count must be >= 100,000/mm^3

    Hemoglobin must be >= 10 g/dL

    Total bilirubin must be =< upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin

    Alkaline phosphatase must be =< 2.5 x ULN for the lab

    Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab

    Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULN

    Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the requirements above are met

    Patients with alkaline phosphatase that is > ULN but =< 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease

    Adequate renal function determined within 6 weeks prior to randomization defined as the most recent serum creatinine =< ULN or measured or calculated creatinine clearance > 60 mL/min

    Left ventricular ejection fraction (LVEF) assessment must be performed within 90 days prior to randomization; (LVEF assessment performed by 2-dimensional [D] echocardiogram is preferred; however, multi gated acquisition [MUGA] scan may be substituted based on institutional preferences;) the LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal

    Exclusion Criteria:

    T4 tumors including inflammatory breast cancer

    Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 90 days prior to randomization

    Synchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)

    Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)

    History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization

    Previous therapy with anthracyclines or taxanes for any malignancy

    Chemotherapy administered for the currently diagnosed breast cancer prior to randomization

    Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization

    Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:

    Active cardiac disease

    • Angina pectoris that requires the current use of anti-anginal medication;
    • Ventricular arrhythmias except for benign premature ventricular contractions;
    • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
    • Conduction abnormality requiring a pacemaker;
    • Valvular disease with documented compromise in cardiac function; or
    • Symptomatic pericarditis

    History of cardiac disease

    • Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function;
    • History of documented congestive heart failure (CHF); or
    • Documented cardiomyopathy

    Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)

    Active hepatitis B or hepatitis C with abnormal liver function tests

    Patients known to be human immunodeficiency virus (HIV) positive with a baseline cluster of differentiation (CD)4 count of < 250 cells/mm^3 or have a history of acquired immune deficiency syndrome (AIDS) indicator conditions

    Intrinsic lung disease resulting in dyspnea

    History of hospitalization in past 12 months for diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic nonketotic syndrome (HHNS)

    Active infection or chronic infection requiring chronic suppressive antibiotics

    Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0

    Conditions that would prohibit administration of corticosteroids

    Chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)

    Known hypersensitivity to any of the study drugs or excipients, e.g., polysorbate 80 and Cremophor® EL

    Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up

    Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

    Pregnancy or lactation at the time of study entry; (note: pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to randomization)

    Use of any investigational product within 4 weeks prior to randomization

    Principal Investigator: Bhuvaneswari Ramaswamy, MD

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  • open for enrollment

    Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer

    Protocol: OSU-13165

    Eligibility:

    Inclusion Criteria:

    Women diagnosed with breast cancer stages I-III initiating first line adjuvant or neoadjuvant doxorubicin hydrochloride (DOX) chemotherapy

    Postmenopausal defined as amenorrhea > 12 months or follicle stimulating hormone (FSH) and estradiol in institutional postmenopausal range

    Ability to understand English and read and write at the 8th grade level and give a written informed consent document

    Exclusion Criteria:

    Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease, with the exception of osteoarthritis and fibromyalgia

    Concurrent other malignancy or metastatic malignancy of any kind

    Reported diagnosis of major depression or anxiety disorder prior to breast cancer (BC) diagnosis

    Currently prescribed psychotropic medications including anti-depressants

    Known bleeding disorders

    History of diabetes mellitus, heart disease or stroke

    Current use of warfarin or other anticoagulants

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements

    Pregnant or nursing women

    Concurrent use of daily full dose aspirin (>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products or steroids; one month washout period is required prior to randomization

    Unable to give informed consent

    Tetracycline allergy

    Any contraindication to magnetic resonance imaging (MRI)/PET examination including but not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia; (however, this portion is optional and if patient is otherwise eligible, can enroll in study without participating in imaging study)

    Principal Investigator: Maryam B Lustberg, MD, MPH

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  • open for enrollment

    Lymph Node Dissection and Radiation Therapy in Treating Patients with Breast Cancer Previously Treated with Chemotherapy and Surgery

    Protocol: ALLIANCE-A011202

    Eligibility:

    Inclusion Criteria:

    Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition

    No inflammatory breast cancer

    No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix

    All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy

    Note: Biopsy of intramammary nodes does not fulfill eligibility criteria

    Patients must have had estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER2) status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy

    Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled

    Patients must have completed all chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery); patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes

    Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered; more than 4 cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist

    Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen); therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an institutional review board (IRB)-approved clinical trial

    All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy

    Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact eligibility

    No neoadjuvant endocrine therapy

    No neoadjuvant radiation therapy

    No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy

    No prior history of ipsilateral breast cancer (invasive disease or ductal carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed

    No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis

    No history of prior or concurrent contralateral invasive breast cancer; benign breast disease; LCIS or DCIS of contralateral breast is allowed

    Patients must not be pregnant or nursing

    Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential

    Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

    INTRA-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA

    Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy

    A minimum of 1 sentinel node and a maximum of 6 total nodes (sentinel + non-sentinel) are identified and excised by the surgeon; patients who do not have an identifiable sentinel lymph node will not proceed to registration/randomization

    At least one lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm in greatest dimension identified on intra-operative pathologic assessment

    Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+)

    If on final pathology, more than 8 lymph nodes are seen pathologically, then the patient should discontinue study

    Axillary lymph node dissection (ALND) is not to be performed prior to registration/randomization

    POST-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA

    For cases where ALND has not been performed and one of the following is true: 1) intra-operative evaluation of sentinel lymph node could not be/was not performed and final pathology identified a positive lymph node (sentinel or non-sentinel) with metastasis greater than 0.2 mm OR 2) lymph node (sentinel or non-sentinel) considered negative on intra-operative evaluation was found to be positive on final pathology (with metastasis greater than 0.2 mm)

    Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy; negative margin (by either breast conservation or mastectomy) on final pathology where negative margin is defined as no tumor on ink

    At least one lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm in greatest dimension identified by H&E staining on final pathology (for cases where intra-operative evaluation was not performed, or was negative and completion dissection was not performed)

    Among the minimum of 1 and the maximum of 6 lymph nodes (sentinel + non-sentinel) identified and excised by the surgeon, no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised;

    Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+)

    For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration /randomization

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