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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
More Information


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.