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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
24-week clinical benefit rate
Objective response rate
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
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,641 Total Patients Enrolled
45 Trials studying Breast Cancer
60,849 Patients Enrolled for Breast Cancer
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,041 Total Patients Enrolled
42 Trials studying Breast Cancer
35,333 Patients Enrolled for Breast Cancer
Payal D. Shah, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.People with weakened immune systemsI am not allergic to olaparib, palbociclib, fulvestrant, or their ingredients.I have active hepatitis.I have not had a blood transfusion in the last 120 days.You have a disease that can be measured or seen on a CT or MRI scan.I have not been treated with olaparib or palbociclib for my metastatic breast cancer.I haven't had chemotherapy or radiotherapy (except for pain relief) in the last 3 weeks.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 am 18 years old or older.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 had platinum-based chemo for breast cancer over a year before my metastatic diagnosis.I had platinum chemotherapy for advanced breast cancer without the cancer getting worse.I had platinum-based treatment for a cancer other than breast cancer, and have been disease-free for over 5 years.My organs and bone marrow are working well.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 am willing to follow the study rules, use birth control, stop certain medications, and undergo a biopsy if needed.I have had a bone marrow transplant in the past.I have a harmful BRCA1 or BRCA2 gene mutation.You are expected to live for at least 16 weeks.I haven't had any other cancer in the last 5 years, except for those allowed in the study.I am considered suitable for hormone therapy for my cancer.You are not in good health and may be at risk for medical complications.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Level 0
- Group 2: Phase I Level 1
- Group 3: Phase I Level 2
- Group 4: Phase II
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are participating in the trial?
"Affirmative. The information contained in the clinicaltrials.gov database confirms that this research project, which was initially posted on October 15th 2020, is still actively recruiting participants. A total of 54 individuals are required to be enrolled from a single medical facility."
Answered by AI
Is there a precedent for using Fulvestrant in clinical trials?
"At present, 412 clinical studies are in progress for Fulvestrant. Of those trials, 68 have reached the late stage of development known as Phase 3. These experiments are mainly based within Rochester, Minnesota; however there are 19,790 locations conducting research with this drug globally."
Answered by AI
Is the program currently enrolling participants?
"Sources on clinicaltrials.gov reveal that this medical experiment is in search of participants. The trial was inaugurated on October 15th 2020 and its parameters were most recently modified on August 17th 2022."
Answered by AI
In what cases is Fulvestrant typically utilized?
"Fulvestrant can mitigate the symptoms of chemotherapy, progression, disease and pharmacotherapy."
Answered by AI
Has the FDA sanctioned the use of Fulvestrant for treatment?
"As this is a Phase 1 trial, with limited data on safety and efficacy, Fulvestrant was assigned an estimation of 1 out of 3 on the scale."
Answered by AI
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