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ACTIVE NOT RECRUITING

NCT02513394

PHASE3

PALbociclib CoLlaborative Adjuvant Study

Sponsor: Alliance Foundation Trials, LLC.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5796

Start Date

2015-08

Completion Date

2028-12

Last Updated

2026-02-10

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

Palbociclib

DRUG

Standard Adjuvant Endocrine Therapy

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 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. 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 * 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).

Locations (437)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

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

Sharp Memorial Hospital

San Diego, California, United States

Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

UCSF Helen Diller Comprehensive Cancer Center

San Francisco, California, United States

Kaiser Permanente San Jose Medical Center

San Jose, California, United States

Kaiser Permanente San Leandro Medical Center

San Leandro, California, United States

Kaiser Permanente San Marcos Medical Center

San Marcos, California, United States

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, United States

Kaiser Permanente South San Francisco Medical Center

South San Francisco, California, United States

Stanford Women's Cancer Center

Stanford, California, United States

Kaiser Permanente Vallejo Medical Center

Vallejo, California, United States

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, United States

Kaiser Permanente Cadillac Medical Center

West Los Angeles, California, United States

Kaiser Permanente Woodland Hills Medical Center

Woodland Hills, California, United States

Western States Cancer Research NCORP

Denver, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Memorial Sloan Cancer Center - Hartford Healthcare Center Institute at HOCC

New Britain, Connecticut, United States

Christiana Health System - Christiana Hospital

Newark, Delaware, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine Sylvester Cancer Center

Miami, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Advent Health Orlando

Orlando, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Cancer Center LAPS

Chicago, Illinois, United States

Cancer Care Specialist of Central Illinois

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

NorthShore University Health System - Evanston Hospital

Evanston, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Joliet Oncology Hematology Associates Limited

Joliet, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

OSF Saint Anthony Medical Center

Rockford, Illinois, United States

Orchard Healthcare Research Inc.

Skokie, Illinois, United States

NorthShore Hematology Oncology-Libertyville

Skokie, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Indiana University - Melvin and Bren Simon Cancer Center LAPS

Indianapolis, Indiana, United States

IU Health Ball Memorial Hospital

Muncie, Indiana, United States

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

McFarland Clinic, P.C.

Ames, Iowa, United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Iowa Oncology Research Assoc

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates - Des Moines

Des Moines, Iowa, United States

Covenant Medical Center

Waterloo, Iowa, United States

University of Kentucky-Markey Cancer Center

Lexington, Kentucky, United States

Norton Cancer Institute - Brownsboro

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Eastern Maine Medical Center d/b/a Northern Light Cancer Institute

Bangor, Maine, United States

New England Cancer Specialists - Scarborough

Scarborough, Maine, United States

Anne Arundel Medical Center

Annapolis, Maryland, United States

Mercy Medical Center