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PALbociclib CoLlaborative Adjuvant Study

Trial Status: Closed to Accrual

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.

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).

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL
Emory University Hospital Midtown
Status: CLOSED_TO_ACCRUAL
Contact: Jane Lowe Meisel

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Danvers
Mass General / North Shore Cancer Center
Status: ACTIVE
Milford
Dana-Farber / Brigham and Women's Cancer Center at Milford Regional
Status: ACTIVE
South Weymouth
Dana-Farber / Brigham and Women's Cancer Center at South Shore
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Christian Hospital
Status: CLOSED_TO_ACCRUAL
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Nashua
Norris Cotton Cancer Center-Nashua
Status: ACTIVE

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: CLOSED_TO_ACCRUAL

New Mexico

Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: CLOSED_TO_ACCRUAL
New Mexico Oncology Hematology Consultants
Status: CLOSED_TO_ACCRUAL
Presbyterian Kaseman Hospital
Status: CLOSED_TO_ACCRUAL
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Las Cruces
Memorial Medical Center - Las Cruces
Status: CLOSED_TO_ACCRUAL

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
New York
Icahn School of Medicine at Mount Sinai
Status: CLOSED_TO_ACCRUAL
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Thomas Jefferson University Hospital
Status: CLOSED_TO_ACCRUAL
University of Pennsylvania / Abramson Cancer Center
Status: COMPLETED
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
South Jordan
South Jordan Health Center
Status: CLOSED_TO_ACCRUAL

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Daeryl Williamson

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Alliance Foundation Trials, LLC.

  • Primary ID AFT-05
  • Secondary IDs NCI-2015-02057, 2014-005181-30, BIG 14-03, ABCSG 42, s16-00989
  • Clinicaltrials.gov ID NCT02513394