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.
- Triple Negative Breast Cancer
2 Primary · 18 Secondary · Reporting Duration: Up to approximately 72 months
2 Treatment Groups
pembrolizumab + carboplatin and gemcitabine
1 of 2
pembrolizumab + olaparib
1 of 2
460 Total Participants · 2 Treatment Groups
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Who is running the clinical trial?
Age 18+ · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
How old are they?
|18 - 65||100.0%|
What site did they apply to?
|UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)||100.0%|
What portion of applicants met pre-screening criteria?
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." - Anonymous Online Contributor
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor