Trials / Completed
CompletedNCT03685331
HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer
Harnessing Olaparib, Palbociclib and Endocrine Therapy: A Phase I/II Trial of Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer (HOPE)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this research study is to learn whether the investigational combination of olaparib, palbociclib, and fulvestrant is safe in patients with estrogen receptor-positive breast cancer and BRCA1 or BRCA2 mutations.
Conditions
- Metastatic Breast Cancer
- Locally Advanced Breast Cancer
- Advanced Breast Cancer
- BRCA2 Mutation
- BRCA1 Mutation
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palbociclib | Combination of palbociclib, olaparib, and fulvestrant. |
| DRUG | Olaparib | Combination of palbociclib, olaparib, and fulvestrant. |
| DRUG | Fulvestrant | Combination of palbociclib, olaparib, and fulvestrant. |
Timeline
- Start date
- 2020-10-15
- Primary completion
- 2025-08-01
- Completion
- 2025-12-01
- First posted
- 2018-09-26
- Last updated
- 2026-01-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03685331. Inclusion in this directory is not an endorsement.