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Olaparib + Pembrolizumab for Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- 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.
- Group 1: Olaparib in Combination with Pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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