PALbociclib CoLlaborative Adjuvant Study

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02513394

Run by

Alliance Foundation Trials, LLC.

People needed

5796

Starts

2015-08-01

Expected to finish

2028-12-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 adequate (definitive) 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 below the upper limit of the institutional normal range (ULN) or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

You may not qualify if…

• 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
• Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
• Patients on antiretroviral therapy.
• Patients with clinically significant history of any chronic liver disease.
• Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).

Where it is running

• Southern Cancer Center PC - Providence — Mobile, Alabama, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Cancer Center — Anchorage, Alaska, United States
• Mayo Clinic in Arizona — Phoenix, Arizona, United States
• Kaiser Permanente Anaheim Medical Center — Anaheim, California, United States
• Kaiser Permanente Baldwin Park Medical Center — Baldwin Park, California, United States
• Kaiser Permanente Bellflower Medical Center — Bellflower, California, United States
• Kaiser Permanente Fontana Medical Center — Fontana, California, United States
• Marin Cancer Care — Greenbrae, California, United States
• Marin Cancer Center — Greenbrae, California, United States
• Kaiser Permanente Harbor City Medical Center — Harbor City, California, United States
• Kaiser Permanente Irvine Medical Center — Irvine, California, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• Long Beach Memorial Medical Center - Todd Cancer Institute — Long Beach, California, United States
• Kaiser Permanente Sunset Medical Center — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Kaiser Permanente Oakland Medical Center — Oakland, California, United States
• Palo Alto Medical Foundation Health Care — Palo Alto, California, United States
• Kaiser Permanente Panorama City Medical Center — Panorama City, California, United States
• Kaiser Permanente Riverside Medical Center — Riverside, California, United States
• Kaiser Permanente Roseville Medical Center — Roseville, California, United States
• Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
• University of California — San Diego, California, United States
• Kaiser Permanente San Diego Medical Center — San Diego, California, United States
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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