A Phase III Study of Standard Hormonal Therapy Alone and with Palbociclib in Patients with Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer

Full Title

AFT-05: PALLAS: 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

Purpose

Palbociclib is a drug approved to treat metastatic breast cancer that is fueled by estrogen and does not produce HER2. It is given in combination with hormonal therapies. Palbociclib blocks the activity of two enzymes (called CDK4 and CDK6) that are involved in the growth of some breast cancers.

In this study, researchers want to see if adding palbociclib to standard hormonal therapy is better than standard hormonal therapy alone in patients with early-stage breast cancers that are fueled by estrogen and are HER2-negative. Patients will be randomly assigned to receive palbociclib plus hormonal therapy (such as tamoxifen, anastrozole, letrozole, or exemestane), or hormonal therapy alone. All of these medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage II or III breast cancer that is hormone receptor-positive and HER2-negative.
  • Patients must have started or be planning to start hormonal therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Diana Lake at 646-888-5444.

Protocol

16-073

Phase

III

Investigator

Co-Investigators

Diseases