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PALLAS AFT – 05


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
Therapeutic Area Breast Cancer
Principal Investigator John Erban, MD
Min Age 18 Years
Gender Both
Contact Madeline Arthur
617-636-7651
More Information https://clinicaltrials.gov/ct2/show/NCT02513394

Overview

The purpose of this study is to compare any good and bad effects of using 2 years of Palbociclib in combination with standard anti-hormone therapy to using standard anti-hormone therapy alone and to evaluate the likelihood that invasive breast cancer returns.

Study Details

Inclusion Criteria

  • Pre- and postmenopausal women or men with Stage II or Stage III 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

Exclusion Criteria

  • Patients with Stage I or IV breast cancer are not eligible
  • Prior therapy with any CDK inhibitor.

Study Requirements

Participants will either be in Arm A or Arm B. Arm A is the experimental arm with Palbociclib given at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years. Arm B participants will receive standard adjuvant endocrine therapy for a duration of at least 5 years. Participants will also have bloods draws and take part in questionnaires for this study.