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PARP Inhibitor

Pembrolizumab + Olaparib for Breast Cancer

Phase 2
Recruiting
Led By Yuan Yuan, MD
Research Sponsored by Yuan Yuan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have ECOG 0 or 1
Have documented BRCA deleterious germline or somatic mutation and/or HDR-defect
Must not have
Is receiving systemic steroid therapy within three days prior to the first dose of pembrolizumab or receiving any other form of immunosuppressive medication
Is expected to require any other form of systemic or localized antineoplastic therapy while on trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial will evaluate the use of immunotherapy and PARP inhibition to treat advanced breast cancer associated with a germline BRCA mutation or HDR-defect.

Who is the study for?
This trial is for adults with advanced breast cancer that's linked to a BRCA mutation or HDR-defect. Participants must have measurable disease, adequate organ function, and a life expectancy of at least 16 weeks. Women should be postmenopausal or use two forms of contraception; men must use condoms. Exclusions include recent other treatments, additional cancers needing treatment, inability to take oral meds, certain infections like HIV/Hepatitis B/C, active autoimmune diseases, and known allergies to the drugs tested.
What is being tested?
The study tests pembrolizumab (an immunotherapy drug) combined with olaparib (a PARP inhibitor) in patients with incurable advanced breast cancer due to BRCA mutations or HDR defects. The main goal is to see how well this combination works by measuring the overall response rate according to specific criteria.
What are the potential side effects?
Possible side effects may include immune-related reactions affecting organs, infusion-related symptoms during administration of pembrolizumab, nausea from olaparib intake along with potential blood cell count changes leading to anemia or infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have a confirmed BRCA mutation or HDR defect.
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My breast cancer has a BRCA mutation or HDR defect and is getting worse despite treatment.
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I have a tumor that can be measured and hasn't been treated with radiation.
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I am postmenopausal or cannot have children and agree to use two effective birth control methods.
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I have a preserved tumor sample available for testing.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on steroids or immunosuppressants as of three days ago.
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I will not need any cancer treatment other than the trial.
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I have another cancer that is getting worse or needs treatment.
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I have a history of HIV or active Hepatitis B/C.
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I have an autoimmune disease treated with medication in the last 2 years.
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I have received an organ or tissue transplant from another person.
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I have cancer that has spread to my brain or spinal cord.
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I have a lung condition not caused by an infection.
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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I cannot take pills by mouth and have stomach issues affecting medication absorption.
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I have not received a live vaccine in the last 30 days.
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I have not had chemotherapy, targeted therapy, or radiation in the last 3 weeks.
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I have lasting side effects from cancer treatment, but not hair loss.
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I have active tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR) per RECIST1.1
Secondary study objectives
Clinical Benefit Rate (CBR = CR+PR+SD) per RECIST 1.1
Duration of Response (DOR) for Complete Response (CR) and Partial Response (PR) per RECIST 1.1
Overall survival (OS)
+1 more
Other study objectives
Exploratory: CBR based on immune-related (ir)RECIST
Exploratory: DOR based on immune-related (ir)RECIST
Exploratory: ORR based on immune-related (ir)RECIST
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + OlaparibExperimental Treatment2 Interventions
This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

Yuan YuanLead Sponsor
1 Previous Clinical Trials
41 Total Patients Enrolled
Monica MitaLead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled
2 Trials studying Breast Cancer
82 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,963 Total Patients Enrolled
58 Trials studying Breast Cancer
7,388 Patients Enrolled for Breast Cancer

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03025035 — Phase 2
Breast Cancer Research Study Groups: Pembrolizumab + Olaparib
Breast Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03025035 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03025035 — Phase 2
~4 spots leftby Aug 2026
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