Clinical Trial: NCT03685331
HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Abramson Cancer Center at Penn Medicine |
| Information Provided By: | Abramson Cancer Center at Penn Medicine |
| Last Update Posted: | 2026-01-09 |
Study Overview
Brief 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.
Official Title
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)
Conditions
Metastatic Breast Cancer, Locally Advanced Breast Cancer, Advanced Breast Cancer, BRCA2 Mutation, BRCA1 Mutation
Intervention / Treatment
- Drug: Palbociclib
- Drug: Olaparib
- Drug: Fulvestrant
Other Study ID Numbers
- UPCC 21118
Start Date (Actual)
2020-10-15
Primary Completion Date (Actual)
2025-08-01
Study Completion Date (Actual)
2025-12-01
Enrollment (Actual)
9
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Abramson Cancer Center at Penn Medicine |
| Information Provided By: | Abramson Cancer Center at Penn Medicine |
| Last Update Posted: | 2026-01-09 |
Study Overview
Brief 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.
Official Title
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)
Conditions
Metastatic Breast Cancer, Locally Advanced Breast Cancer, Advanced Breast Cancer, BRCA2 Mutation, BRCA1 Mutation
Intervention / Treatment
- Drug: Palbociclib
- Drug: Olaparib
- Drug: Fulvestrant
Other Study ID Numbers
- UPCC 21118
Start Date (Actual)
2020-10-15
Primary Completion Date (Actual)
2025-08-01
Study Completion Date (Actual)
2025-12-01
Enrollment (Actual)
9
Study Type
Interventional
Phase
Phase 1