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Olaparib + Pembrolizumab for Breast Cancer
Study Summary
This trial is comparing the efficacy of two different treatments for triple negative breast cancer - olaparib plus pembrolizumab versus chemotherapy plus pembrolizumab. The primary hypotheses are that olaparib plus pembrolizumab will be superior to chemotherapy plus pembrolizumab in terms of progression-free survival and overall survival.
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.Trial Design
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Who is running the clinical trial?
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- I have a recent biopsy (within 3 years) of a tumor that wasn't treated with radiation.I am currently being treated for an infection.I am not pregnant or breastfeeding, can test negative for pregnancy, and will use birth control or abstain from sex.I have had serious heart failure or a heart attack in the last 6 months.I haven't had major surgery in the last 2 weeks or still recovering from one.I have received an organ or tissue transplant from another person.I still have side effects from past treatments that haven't fully gone away.I have not had a live vaccine in the last 30 days.I agree to use contraception or remain abstinent and not donate sperm while on the study drugs and for 95 days after.I am allergic to pembrolizumab, olaparib, carboplatin, gemcitabine, or their components.I have been treated with specific immune therapy drugs or was in a study for pembrolizumab.I have cancer that has spread to my brain or spinal cord.I have stopped any medications that can't be taken with the study drugs 7 days before starting the trial.You have been diagnosed with HIV.My cancer has not worsened by Week 18 according to a specific assessment.I have not had active treatment for another cancer, except for certain skin cancers or in situ cancers, in the last 5 years.I have been treated with anthracycline or taxane for my cancer unless it was not suitable for me.I have a history of Hepatitis B or active Hepatitis C.I have had a bone marrow or cord blood transplant.I have an active case of tuberculosis.I cannot take pills by mouth or have a condition that affects how my body absorbs them.I have moderate to severe nerve pain or damage.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I stopped taking carboplatin and gemcitabine because of side effects.I am taking medication that strongly affects liver enzymes and cannot stop during the study.I stopped taking pembrolizumab because of side effects.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with olaparib or another PARP inhibitor before.I have been treated for an autoimmune disease in the last 2 years.I have been diagnosed with MDS/AML or have symptoms suggesting it.You are expected to live for at least 27 weeks from the start of the study treatment.I am taking medication that strongly affects liver enzymes and can't stop during the study.I have or had lung disease that affects the tissue and space around the air sacs.I had radiotherapy less than 2 weeks before starting the study treatment.You have a very bad allergic reaction (Grade 3 or higher) to the study medications or any of their ingredients.Have a disease that can be measured using specific guidelines.I've had fewer than 4 rounds of chemo with pembrolizumab.I have had lung inflammation that needed steroids or have it now.I don't have health issues that could affect the study's results or my participation.My organs are functioning well, as tested within the last 10 days.I have not taken any colony-stimulating factors in the last 2 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I have only mild side effects from my initial cancer treatment, not including hair loss.My triple-negative breast cancer is either inoperable and untreated by chemotherapy, or it has spread and hasn't been treated with chemotherapy.I've had 4 to 6 rounds of initial cancer treatment without stopping pembrolizumab, carboplatin, or gemcitabine.I can start the required medication doses after initial treatment.
- Group 1: Pembrolizumab + Olaparib
- Group 2: Pembrolizumab + Carboplatin + Gemcitabine
- 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
What mitigating measures are taken to ensure the safe use of Pembrolizumab?
"While there is evidence of Pembrolizumab's safety, no clinical data exists for its efficacy in this Phase 2 trial; thereby earning it a score of 2."
What are the anticipated outcomes of this clinical research?
"Merck Sharp & Dohme Corp., the sponsor of this study, has declared Overall Survival (OS) as its primary outcome that will be monitored for a maximum of 72 months. Secondary outcomes to be evaluated include Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Change From Baseline in Emotional Functioning With The EORTC QLQ-C30, and Time To Deterioration in HRQoL Utilizing The EOR"
What is the size of the cohort participating in this research?
"At the present moment, this specific study is not enrolling. It was posted on December 19th 2019 and last updated on October 10 2022; if you wish to explore other options, there are 2351 trials actively recruiting patients with triple negative breast neoplasms and 2018 studies involving Pembrolizumab that require participants."
Are volunteers currently being accepted for this experiment?
"Currently, this clinical trial is not accepting new participants. Initially posted on December 19th 2019 and last updated October 10th 2022, the study has been suspended for now. For individuals seeking out other trials, 2351 studies are actively searching for people with triple negative breast neoplasms while 2018 medical research projects centered around Pembrolizumab require enrollees."
To what extent has research been conducted on Pembrolizumab?
"At the present time, there are 2018 clinical trials underway exploring Pembrolizumab. Of these studies, 419 are in Phase 3 and have a global presence with 89680 being conducted across various locations worldwide; notably, Shanghai is hosting many of them."
What are the venues in which this study is being conducted?
"This trial is being conducted at 30 different settings, including Texas Oncology-New Braunfels (Site 0168) in New Braunfels, McGill University Health Centre ( Site 0002) in Montreal, and MSKCC-Bergen (Site 0162) situated in Montvale."
What maladies are typically treated by Pembrolizumab?
"Pembrolizumab is approved for use in treating a variety of cancers, such as non-Hodgkin's lymphoma and recurrent cervical cancer, as well as malignant melanomas on the skin."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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