Study on Palbociclib and Bicalutamide for Treating Androgen Receptor Positive Metastatic Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT02605486
This clinical trial is testing the safety and effectiveness of combining two drugs, palbociclib and bicalutamide, to treat a specific type of breast cancer that is positive for androgen receptors and has spread to other parts of the body.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to see if the combination of palbociclib and bicalutamide is safe and effective for treating a type of breast cancer that is positive for androgen receptors and has spread beyond the breast. Patients will take these medications at home, with palbociclib taken daily for three weeks followed by a week off, and bicalutamide taken daily. The study will monitor patients for side effects and how well the cancer responds to the treatment.
Description
Patients will take the study medications at home. Those who qualify and agree to participate will start treatment with bicalutamide taken once daily and palbociclib taken daily for three weeks, followed by a one-week break. This four-week period is considered one treatment cycle. During the first two cycles, patients will be checked for side effects every two weeks, and then every four weeks in later cycles. These checks will include medical history, physical exams, and blood tests. Patients will keep a diary to track their medication use. Scans to check the cancer's response will be done every eight weeks for the first six cycles, and then every twelve weeks.
In Phase I, the study will determine the best doses of the drugs to use in Phase II. In Phase II, patients will receive the doses determined in Phase I.
Eligibility Criteria
Inclusion Criteria
- Female patients with confirmed invasive breast cancer.
- Cancer must be negative for estrogen and progesterone receptors (less than 1%) and normal for HER2.
- Cancer must be metastatic, meaning it has spread beyond the breast.
- Tissue sample must be available for androgen receptor testing.
- Androgen receptor testing must show the cancer is positive for androgen receptors (1% or more).
- No limit on previous chemotherapy or hormone therapy, but must have had at least one prior hormone therapy if estrogen receptor positive.
- At least two weeks since last chemotherapy, hormone therapy, or radiation, with side effects returned to mild or baseline levels.
- May receive bone-strengthening treatments for bone metastases.
- If there is a history of brain metastases, they must be stable for at least three months.
- No prior treatment with bicalutamide.
- At least three weeks since major surgery with full recovery.
- ECOG performance status of 0 to 2, meaning fully active or able to carry out light work.
- Age 18 or older and postmenopausal.
- No other active cancer requiring treatment.
- Must agree to use effective contraception and not breastfeed during the study.
- Must be able to understand and sign informed consent.
- Must be able to swallow the study medications.
- Must have adequate organ and bone marrow function as shown by specific blood tests.
Exclusion Criteria
- Not recovered from side effects of previous treatments to mild levels.
- Receiving other experimental cancer treatments.
- Previous treatment with CDK4/6 inhibitors or anti-androgen therapy.
- Allergic reactions to similar drugs.
- Uncontrolled illnesses, including infections, heart problems, or psychiatric conditions.
- Pregnant or breastfeeding women.
- History of long-QT syndrome or family history of it.
- Taking medications that affect the metabolism of palbociclib.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Cancer Center @ Suffolk | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Nassau | 11553 | Uniondale | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.