HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer

Phase 1 Completed 9 enrolled Abramson Cancer Center at Penn Medicine

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2020-10-15
Primary completion: 2025-08-01
Completion: 2025-12-01

Publications

Bruno L, Ostinelli A, Waisberg F, Enrico D, Ponce C, Rivero S, Blanco A, Zarba M, Loza M, Fabiano V, Amat M, Pombo MT, Noro L, Chacon M, Colo F, Chacon R, Nadal J, Nervo A, Costanzo V. Cyclin-Dependent Kinase 4/6 Inhibitor Outcomes in Patients With Advanced Breast Cancer Carrying Germline Pathogenic Variants in DNA Repair-Related Genes. JCO Precis Oncol. 2022 Mar;6:e2100140. doi: 10.1200/PO.21.00140.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fulvestrant	Small molecule	500 mg	Intramuscular
Subject	Olaparib	Small molecule	300 mg	Oral
Subject	Palbociclib	Small molecule	75 mg	Oral
Subject	Palbociclib	Small molecule	100 mg	Oral
Subject	Palbociclib	Small molecule	125 mg	Oral

HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer

Summary

Timeline

Publications

Drugs

Indications