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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

    Phase II w/wo nivolumab in first- or second-line metastatic triple-negative breast cancer

    Protocol: OSU-17384

    Principal Investigator: Robert Wesolowski, MD

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  • open for enrollment

    Circadian Thermal Sensing to Detect Breast Disease

    Protocol: OSU-15211

    Eligibility:

    Inclusion Criteria: - Women with a BI-RADS category 4 or 5 designation on mammogram - Women with a BI-RADS category 4 or 5 designation on breast ultrasound - Women with a BI-RADS category 4 or 5 designation on breast MRI - Women who are willing to undergo a complete evaluation and/or biopsy procedure if recommended by the treating physician Exclusion Criteria: - Less than 21 years of age - Unable to sign the consent form - Pregnant or lactating - Physically unable to wear the Cyrcadia CBR™ for 24 hours - Previous mastectomy - Any breast surgery or biopsy within the last 90 days - Any trauma to the breast within the last 90 days - Any biopsy or treatment for the BI-RADS category 4 or 5 abnormality - Refusal to undergo recommended diagnostic evaluation of the BI-RADS category 4 or 5 abnormality

    Principal Investigator: William B Farrar, 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

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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

    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

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