Triple-Drug Combo for BRCA-Mutated Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByPayal D. Shah, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Abramson Cancer Center at Penn Medicine

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults with estrogen receptor-positive, HER2-negative metastatic breast cancer who have a BRCA1 or BRCA2 mutation. They should be relatively healthy and not have had certain treatments recently. Women must use two forms of contraception, and men must also ensure their partners use contraception to prevent pregnancy.

Inclusion Criteria

My breast cancer is advanced, cannot be surgically removed, and is hormone receptor positive but not HER2 positive.

I have had up to 2 chemotherapy treatments for my advanced breast cancer.

I am fully active or can carry out light work.

I am postmenopausal.

I agree to use two effective birth control methods during and for 1 month after the study.

I am a male and will use two effective birth control methods during and 3 months after the study.

I have a harmful BRCA1 or BRCA2 gene mutation.

Exclusion Criteria

I have brain metastases that are causing symptoms and are not under control.

My heart's electrical cycle is longer than normal, or I have a family history of long QT syndrome.

I cannot swallow or absorb pills.

I am not allergic to olaparib, palbociclib, fulvestrant, or their ingredients.

I have active hepatitis.

I have not been treated with olaparib or palbociclib for my metastatic breast cancer.

I have not had major surgery in the last 2 weeks.

I am not taking strong or moderate drugs that affect liver enzyme CYP3A.

I have lasting side effects from cancer treatment, but not hair loss or nerve issues.

My condition is either MDS or shows signs of MDS/AML.

I have had a bone marrow transplant in the past.

Participant Groups

The HOPE trial is testing the safety of combining three drugs: Olaparib, Palbociclib, and Fulvestrant in patients with specific genetic mutations associated with breast cancer. The goal is to see if this combination works better than current treatments.

4Treatment groups

Experimental Treatment

Group I: Phase IIExperimental Treatment3 Interventions

(28-day cycle) Olaparib 300 mg by mouth twice a day, days 1-28; fulvestrant 500 mg intramuscularly once monthly on Day 1 of each cycle + 500 mg intramuscularly on Cycle 1 Day 15; palbociclib dose as per maximum tolerated dose determined during Phase I, by mouth daily, days 1-21 Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.

Group II: Phase I Level 2Experimental Treatment3 Interventions

(28-day cycle) 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 125 mg by mouth daily, days 1-21, beginning at cycle 1 Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.

Group III: Phase I Level 1Experimental Treatment3 Interventions

(28-day cycle) 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 100 mg by mouth daily, days 1-21, beginning at cycle 1 Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.

Group IV: Phase I Level 0Experimental Treatment3 Interventions

(28-day cycle) 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 75 mg by mouth daily, days 1-21, beginning at cycle 1

Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Faslodex for: