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Hormone Therapy

Triple-Drug Combo for BRCA-Mutated Breast Cancer

Phase 1

Waitlist Available

Led By Payal D. Shah, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Symptomatic uncontrolled brain metastases

QTc >470 msec on 2 or more time points or a family history of long QT syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of study treatment until the date of progression, an estimated average of 7 months

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing the safety of a three-drug combo for breast cancer patients with BRCA1 or BRCA2 mutations.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from Olaparib include nausea, fatigue, blood cell count changes leading to infections or bleeding problems; Palbociclib may cause low white blood cell counts increasing infection risk; Fulvestrant can cause injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am fully active or can carry out light work.

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I am postmenopausal.

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

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

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I have a harmful BRCA1 or BRCA2 gene mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I cannot swallow or absorb pills.

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

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I have active hepatitis.

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

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

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

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

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

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I have had a bone marrow transplant in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of study treatment until the date of progression, an estimated average of 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of study treatment until the date of progression, an estimated average of 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of study treatment until the date of progression, an estimated average of 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

24-week clinical benefit rate

Objective response rate

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

FDA approved

Olaparib

FDA approved

Fulvestrant

FDA approved

0 / 18Eligibility criteria met