A Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer.
- Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps which is known to regulate cell growth. Laboratory testing has suggested palbociclib may stop the growth of hormone receptor positive breast cancer.
- Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation. During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor. It is standard of care for premenopausal women to take tamoxifen and for postmenopausal women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone receptor positive breast cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Pilot Feasibility Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive Invasive Breast Carcinoma|
- Treatment Discontinuation Rate [ Time Frame: 2 Years ] [ Designated as safety issue: No ]To evaluate the treatment discontinuation rate at 2 years for patients receiving combination therapy with endocrine therapy plus palbociclib.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: Palbociclib, Aromatase Inhibitor
CDK 4/6 inhibitor
Other Names:Drug: Endocrine Therapy
After the screening procedures confirms that the participant is able to participate in the study. The participant will be given a dosing diary for each treatment cycle. Each treatment cycle lasts 28 days, during which time the participant will take Palbociclib once a day on days 1-21 of each 28 day cycle and the aromatase inhibitor that the participant is already taking once a day every day. The diary will also include special instructions for taking the study drug(s).
All participants participating in the research study will receive the same dose of Palbociclib.
While participating in the research study the participant will have the following tests and procedures:
- Clinical Exams: The participant will have a physical exam on the first day of the month for first three months of therapy. After that, the participant will have a physical exam every other month until the end of the first year of therapy. After the first year, the participant will have a physical exam every 3 months during the second year of therapy. During the physical exam, the participant will be asked questions about their general health, questions about any problems that they may be experiencing, and any medications they are taking.
- Blood tests: The participant will have blood drawn on the first and fifteenth days of the first three months of therapy. After that, the participant will have blood drawn every month for the remainder of the first year of treatment and the every other month until the end of therapy. These tests will be used to determine if the participant is having any side effects related to the study drug.
- Electrocardiograms (EKG): The participant will have an EKG performed on the first day of the first three months of therapy. After that, the participant will have an EKG every other month until the end of the first year of therapy. After the first year of therapy, the participant will have an EKG every 3 months during the second year of therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02040857
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|United States, Indiana|
|Indiana University Health Hospital|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|MGH/North Shore Cancer Center|
|Danvers, Massachusetts, United States, 01923|
|DF/DWCC at Milford Regional Cancer Center|
|Milford, Massachusetts, United States, 01757|
|South Shore Hospital|
|Weymouth, Massachusetts, United States, 02190|
|United States, New Hampshire|
|Dana-Farber/New Hampshire Oncology-Hematology|
|Londonderry, New Hampshire, United States, 03053|
|United States, Pennsylvania|
|University of Pennsylvania-Abramson Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Erica Mayer, MD, MPH||Dana-Farber Cancer Institute|