Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

Protocol: OSU-16010

Full Title

PALLAS: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer

Purpose

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III

study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine

therapy for patients with HR+ / HER2- early breast cancer (EBC).

The purpose of the PALLAS study is to determine whether the addition of palbociclib to

adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2-

early breast cancer. Assessment of a variety of correlative analysis, including evaluation

of the effect of palbociclib in genomically defined tumor subgroups, is planned.

Are you eligible?

Inclusion Criteria:

Signed informed consent prior to study specific procedures.

Age ≥18 years (or per national guidelines).

Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000

patients) or Stage III early invasive breast cancer

Patients with multicentric and/or multifocal and/or bilateral early invasive breast

cancer are eligible if all histopathologically examined tumors meet pathologic

criteria for ER+ and/or PR+ and HER2-.

Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive

breast cancer.

Patients must have undergone breast surgery for the current malignancy. FFPE tumor

tissue block must be confirmed to be received at the central sample repository prior

to randomization.

ECOG performance status 0-1.

Patients must be able and willing to swallow and retain oral medication.

Serum or urine pregnancy test must be negative in premenopausal women within 14 days

of randomization, or in women with amenorrhea of less than 12 months at time of

randomization.

Patients who received neo/adjuvant therapy must be after last dose of chemotherapy

and/or biologic therapy and must have sufficient resolution of side effects.

Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be

after last dose of radiotherapy and must have sufficient resolution of side effects.

Patients must have sufficient resolution of any surgical side effects (no active

wound healing complications).

-Patients must either be initiating or have already started adjuvant hormonal treatment. -

Patients who already received neo/adjuvant endocrine therapy are eligible as long as

they are enrolled within 12 months of initial histological diagnosis and after

completing no more than 6 months of adjuvant endocrine therapy.

Absolute neutrophil count ≥ 1,500/µL

Platelets ≥ 100,000/ mm3

Hemoglobin ≥ 10g/dL

Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin

within normal range in patients with documented Gilbert's Syndrome.

Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT)

≤ 1.5 × institutional ULN.

Serum creatinine within normal institutional limits or creatinine clearance ≥ 60

mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

Exclusion Criteria:

Concurrent therapy with other Investigational Products.

Prior therapy with any CDK inhibitor.

Patients with Stage I or IV breast cancer are not eligible.

History of allergic reactions attributed to compounds of chemical or biologic

composition similar to palbociclib.

Patients receiving any medications or substances that are potent inhibitors or

inducers of

CYP3A isoenzymes within 7 days of randomization.

Uncontrolled intercurrent illness that would limit compliance with study

requirements.

Pregnant women, or women of childbearing potential without a negative pregnancy test

within 14 days prior to randomization.

-Patients with a history of any malignancy are ineligible (for exceptions see: Pallas -

Protocol, v1.0, Exclusion criteria 8).

Patients who previously received endocrine therapy within 5 years prior to diagnosis

of the current malignancy.

Patients on combination antiretroviral therapy.

Patients with clinically significant history of any liver disease.

Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen

therapy is allowable).

Breast Cancer