Olaparib, Palbociclib and Fulvestrant for BRCA-Associated, ER/PR-Positive, Her2-Negative Metastatic Breast Cancer
Clinicaltrials.gov identifier:
NCT03685331
Treatment
Study Contact Information:
Contact: Payal D. Shah, MD by phone: 855-216-0098
Alexandra Torres by phone: 855-216-0098
or Email: [email protected]
HOPE: Olaparib, Palbociclib and Fulvestrant for BRCA-Associated, ER/PR-Positive, Her2-Negative Metastatic Breast Cancer
About the Study
The goal of this study is to find the best dose and measure side effects of palbociclib when given together with and fulvestrant, in treating people with hormone receptor-positive (HR+), metastatic breast cancer who have a or mutation. Palbociclib and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Fulvestrant is a type of treatment that may prevent breast cancer cell growth by blocking and progesterone receptor stimulation.
Type of Study
Phase I of this study is a , dose-escalation study to find the ideal dose of Palbociclib.
Phase II study is study where participants will receive the dose of Palbociclib determined by Phase 1.
What the Study Entails
Patients enrolled in Phase 1 will receive:
- 300 mg by mouth twice a day, days 1-28
- Fulvestrant 500 mg intramuscularly, Day 1 + 500 mg intramuscularly Cycle 0 Day 15
- Palbociclib by mouth, days 1-21 on a 28-day cycle (dose will be determined by dose-escalation schedule)
Treatment will continue until disease progression, unacceptable , or withdrawal of consent.
Study participants will be followed for an estimated average of 7 months.
Study Site
Pennsylvania, Philadephia
Abramson Cancer Center of the University of Pennsylvania
Contact: Payal D. Shah, MD by phone 855-216-0098 or [email protected]
Men and women age 18 years and older can be considered for enrollment in this study if they have:
- Inherited or tumor-based mutation in or
- or locally advanced unresectable (unable to be removed with surgery) breast cancer that is ER and/or PR positive and
- Received treatment with 0-2 prior lines of chemotherapy for breast cancer
- For patients who have received prior platinum-based chemotherapy, contact the study team for inclusion eligibility criteria.
- Deemed a candidate for endocrine therapy
- At least one lesion (measurable and/or non-measurable) that can be assessed by standard imaging (CT or )
- A life expectancy > 16 weeks
- Have had other malignancy within the last 5 years (contact the study team for a list of exceptions)
- Have MDS or features suggestive of MDS/AML (Myelodysplastic syndromes and acute myeloid leukemia)
- Have symptomatic uncontrolled brain metastases
- Are immunocompromised
- Have known active hepatitis
- Have had a prior bone marrow transplant
- Patients who previously progressed on or palbociclib for breast cancer treatment are excluded from Phase 2 of this study.