A Study Evaluating a New Oral Study Drug in Hormone-Receptor Positive Breast Cancer Patients, Following Chemotherapy and Surgery.

What we are studying

The type of breast cancer that you have is usually treated after surgery with standard endocrine therapy for at least five years. In this study, standard endocrine therapy will be given to all patients. In addition to standard endocrine therapy, half of the patients (about 400 patients) will receive the study treatment, palbociclib, and the other half will receive a placebo for the same period of time. If the tests and exams show that you can be in the study and if you agree to take part, you will be randomly assigned (randomized) to one of two Arms (groups): palbociclib or placebo. This means that a computer program will put you into an Arm by chance. Neither you nor your doctor/study team will know which Arm you are in. You will have an equal chance of being placed in either of the two Arms. You will receive appropriate therapy on either Arm of the study. This means that in all cases you will be treated with endocrine therapy, which is the standard treatment for your stage and type of breast cancer. Your health and well-being will be closely monitored.

Who we are studying

  • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Hormone-Receptor (HR) positive
  • HER2 negative
  • Received chemotherapy before surgery
  • Less than 16 weeks since surgery
  • Less than 10 weeks since completion of any radiotherapy after surgery

What is involved

  • Physical exams
  • Medical History
  • 10+ Office visits for the study over the next year
  • HR and HER2 testing
  • Blood draws
  • Quality of Life questionnaires



Contact Information

Study Coordinator
Stacey Lewis

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.