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

COMPLETEDPHASE1

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)

NCT03685331•Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Females/males ≥ age 18
•Germline or somatic deleterious or suspected deleterious mutation in BRCA1 or BRCA2
•Metastatic or locally advanced unresectable breast cancer that is ER and/or PR positive (\>1%) and HER2 nonamplified
•Prior treatment with 0-2 prior lines of chemotherapy for metastatic breast cancer
•Regarding prior platinum-based chemotherapy:
•2. Patients who received platinum for advanced breast cancer are eligible to enter the study provided there was no evidence of disease progression during the platinum chemotherapy.
•3. Patients who received prior platinum-based as a potentially curative treatment for a prior non-breast cancer (e.g., ovarian cancer) with no evidence of disease for 5 years or greater prior to study entry are permitted.
•Deemed a candidate for endocrine therapy (any prior endocrine therapy is permitted; no prior endocrine therapy is also permitted)
•Adequate organ and bone marrow function
•ECOG performance status 0-1
+13 more criteria

Exclusion Criteria

•Involvement in study planning or conduct
•Regarding prior olaparib or palbociclib,
•a) Phase II: Patients who previously progressed on olaparib or palbociclib for metastatic breast cancer treatment are excluded
•Participation in another clinical study with an investigational product during the last 3 weeks
•Systemic chemotherapy or radiotherapy (except palliative) within 3 weeks of start of study treatment
•Major surgery within 2 weeks of start of study treatment
•Other malignancy within the last 5 years with exceptions listed in the protocol
•Concomitant strong or moderate CYP3A inhibitors/ inducers
•Persistent toxicity of prior cancer therapy that is grade ≥ 2 except for alopecia or neuropathy
•MDS or features suggestive of MDS/AML
+10 more criteria

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

October 15, 2020

Primary Completion Date

August 1, 2025

Completion Date

December 1, 2025

Last Updated

January 9, 2026

Enrollment

ACTUAL participants

Conditions

Metastatic Breast CancerLocally Advanced Breast CancerAdvanced Breast CancerBRCA2 MutationBRCA1 Mutation

Interventions

Palbociclib

DRUG

Olaparib

DRUG

Fulvestrant

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

View study

RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

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A Study of Surgery and Radiotherapy in People With Breast Cancer