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Olaparib, Palbociclib and Fulvestrant for BRCA-Associated, ER/PR-Positive, Her2-Negative Metastatic Breast Cancer

Olaparib, Palbociclib and Fulvestrant for BRCA-Associated, ER/PR-Positive, Her2-Negative Metastatic Breast Cancer

Clinicaltrials.gov identifier:
NCT03685331

Treatment:
Breast

Study Contact Information:

Contact: Payal D. Shah, MD by phone:  855-216-0098
Alexandra Torres by phone: 855-216-0098
or Email: PennCancerTrials@emergingmed.com  


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 olaparib and fulvestrant, in treating people with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer who have a BRCA1 or BRCA2 mutation. Palbociclib and Olaparib 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 estrogen and progesterone receptor stimulation.

Type of Study

Phase I of this study is a non-randomized, dose-escalation study to find the ideal dose of Palbociclib. 

Phase II study is non-randomized study where participants will receive the dose of Palbociclib determined by Phase 1. 

What the Study Entails

Patients enrolled in Phase 1 will receive:

  • Olaparib 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 toxicity, 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 PennCancerTrials@emergingmed.com  

This Study is Open To:

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 BRCA1 or BRCA2
  • Metastatic or locally advanced unresectable (unable to be removed with surgery) breast cancer that is ER and/or PR positive and HER2-negative
  • Received treatment with 0-2 prior lines of chemotherapy for metastatic 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 MRI)
  • A life expectancy > 16 weeks
This Study is Not Open To:
  • 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 olaparib or palbociclib for metastatic breast cancer treatment are excluded from Phase 2 of this study.