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PARP Inhibitor
Olaparib + Pembrolizumab for Breast Cancer
Phase 2
Recruiting
Led By Ayca Gucalp, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed histologically confirmed Stage T1c-3N0-3 TNBC (ER/PgR negativity will be defined using IHC per ASCO/CAP criteria/HER2-negativity will be defined using ISH or IHC assays per ASCO/CAP criteria) OR Hormone receptor-positive, HER2-negative breast cancer defined as per ASCO/CAP criteria
All patients must have a germline mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test the efficacy of combining two drugs, pembrolizumab and olaparib, given before surgery, to treat TNBC or HR+ HER2- breast cancers. The study drugs could potentially shrink the cancer, but they may also cause side effects. The goal of the trial is to see if the study drugs will shrink the cancer by a certain percentage compared with its current size, which may improve the outcome of surgery.
Who is the study for?
This trial is for adults with newly diagnosed Stage T1c-3N0-3 Triple Negative Breast Cancer or Hormone Receptor-positive HER2-negative breast cancer, who have a certain gene mutation (BRCA1/2, PALB2, RAD51C/D). They must be able to undergo surgery after treatment and agree to use contraception. Exclusions include prior cancer treatments within 4 weeks, severe allergies to the drugs being tested, active infections or pneumonitis, certain heart conditions, and pregnancy.Check my eligibility
What is being tested?
The study tests combining Olaparib and Pembrolizumab before surgery in patients with specific types of breast cancer. The goal is to see if these drugs can shrink tumors more effectively than current standards. Participants will receive both medications and their tumor size will be measured for comparison.See study design
What are the potential side effects?
Possible side effects from Olaparib may include nausea, fatigue, blood cell count changes leading to infection risk or anemia; while Pembrolizumab could cause immune system-related issues like inflammation in organs or skin problems. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is either triple-negative or hormone receptor-positive and HER2-negative.
Select...
I have a genetic mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
Select...
I agree to have surgery, including lymph node removal and breast removal if needed, after initial treatment.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
pathologically negative MRI-guided biopsy
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Olaparib in Combination with PembrolizumabExperimental Treatment2 Interventions
Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks in conjunction with olaparib (for the first 12 weeks) and cytotoxic chemotherapy (after olaparib has been completed) if administered prior to surgery and if the patient is not deemed to have tumor growth.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,123 Total Patients Enrolled
58 Trials studying Breast Cancer
7,475 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,875 Total Patients Enrolled
202 Trials studying Breast Cancer
81,080 Patients Enrolled for Breast Cancer
Ayca Gucalp, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your tumor should be at least 1.5 cm in size.My recent tests show my organs are functioning well.I am a woman of childbearing potential and my recent pregnancy test was positive.I have not taken any strong antibiotics in the last 2 weeks.My breast cancer has spread to other parts of my body.I have had or currently have lung inflammation treated with steroids.I had radiotherapy less than 2 weeks before starting the study treatment.I have been diagnosed with HIV.I haven't had any severe infections or been hospitalized for infection complications in the last 4 weeks.I have received treatment to fight or prevent breast cancer.I have had breast cancer before.I have a genetic mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.I have an autoimmune disease treated with medication in the last 2 years.I have a history of Hepatitis B or active Hepatitis C.You have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or olaparib.I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.I agree to have surgery, including lymph node removal and breast removal if needed, after initial treatment.My breast cancer is either triple-negative or hormone receptor-positive and HER2-negative.I have not had any cancer treatment or experimental drugs in the last 4 weeks.I have an active TB infection.You cannot have an MRI scan or are allergic to the contrast dye used for the scan.I have not received a live vaccine in the last 30 days.You have a disease that can be measured using a specific medical assessment.I am fully active or can carry out light work.Your heart's pumping ability, measured by a special heart scan, is at least 53%.I have been treated with drugs targeting immune checkpoints.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have another cancer that has gotten worse or needed treatment in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib in Combination with Pembrolizumab
Awards:
This trial has 1 awards, including:- 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.
When was Pembrolizumab given the green light by the FDA?
"Pembrolizumab is a Phase 2 medication, which means that while there is some data supporting its safety, there is no evidence of its efficacy. Our Power team rated it as a 2."
Answered by AI
Are people with the relevant medical condition able to sign up for this clinical trial at this time?
"The clinical trial is searching for participants and was originally posted on 1/31/2022. The last update occurred on 5/12/2022, as indicated by the information available on clinicaltrials.gov."
Answered by AI
How many subjects are included in this research project?
"That is accurate. The information available on clinicaltrials.gov outlines that the recruitment for this trial is ongoing. This trial was posted on 1/31/2022 and was updated most recently on 5/12/2022. There are 23 patients needed to be recruited from 7 sites total."
Answered by AI
Are there multiple sites within the city where this research is being conducted?
"There are seven active clinical trial sites, some of which include Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) in Basking Ridge, Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) in Commack, and Memorial Sloan Kettering Westchester (Limited Protocol Activities) in Harrison."
Answered by AI
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