All > Metastatic Triple Negative Breast Cancer > Lynparza

Pembrolizumab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Virginia Oncology Associates ( Site 0164), Virginia Beach, VABreast CancerPembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 18 Secondary · Reporting Duration: Up to approximately 72 months

Month 72
Change From Baseline in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score
Change From Baseline in Health Outcomes using the European Quality of Life 5-dimension, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Change From Baseline in Health Outcomes using the European Quality of Life 5-dimension, 5-level Questionnaire (EuroQoL EQ-5D-5L) Visual Analogue Scale (VAS) Score
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) Items 29 and 30 Score
Change From Baseline in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score
Malignant Neoplasms
Change From Baseline in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life (QoL) Questionnaire (EORTC QLQ-BR23) Items 1-4, 6, 7, and 8 Score
Month 72
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experienced At Least One Adverse Event (AE)
Overall Survival (OS)
Overall Survival (OS) in Participants with Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors
Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors with a Combined Positive Score (CPS) ≥10
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants with Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors with a Combined Positive Score (CPS) ≥10
Time to Deterioration in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score
Time to Deterioration 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) Items 29 and 30 Score
Time to Deterioration in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score
Time to Deterioration in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1- 5 Score
Time to Deterioration in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life (QoL) Questionnaire (EORTC QLQ-BR23) Items 1-4, 6, 7, and 8 Score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Trial Design

2 Treatment Groups

pembrolizumab + carboplatin and gemcitabine
1 of 2
pembrolizumab + olaparib
1 of 2

Experimental Treatment

460 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

pembrolizumab + carboplatin and gemcitabineExperimental Group · 3 Interventions: Pembrolizumab, Carboplatin, Gemcitabine · Intervention Types: Biological, Drug, Drug
pembrolizumab + olaparibExperimental Group · 4 Interventions: Pembrolizumab, Carboplatin, Olaparib, Gemcitabine · Intervention Types: Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Carboplatin
FDA approved
Olaparib
FDA approved
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 72 months

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,864 Total Patients Enrolled
18 Trials studying Breast Cancer
5,560 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,711 Previous Clinical Trials
4,967,238 Total Patients Enrolled
54 Trials studying Breast Cancer
7,183 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,656 Previous Clinical Trials
7,957,144 Total Patients Enrolled
7 Trials studying Breast Cancer
1,733 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of breast cancer called TNBC that has come back and can't be removed with surgery, or has spread to other parts of your body and has not yet been treated with chemotherapy.
You have a disease that can be evaluated and measured using a specific set of criteria (RECIST 1.1).
You have received at least 4 cycles but not more than 6 cycles of initial treatment with pembrolizumab, carboplatin, and gemcitabine without stopping treatment permanently.
You are expected to live for at least 27 weeks from the start of the study treatment.
You have given a recently obtained or saved (within the last 3 years) sample of a tumor that has not been treated with radiation before.
You are able to perform daily activities without help or with minimal help, as evaluated by a healthcare professional within a week before starting the treatment.
Your organs must be working properly within the 10 days before starting treatment.
If you are a male participant, you must agree to use contraception or be abstinent and not donate sperm during the study and for a certain period after the study ends.
If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study treatment. You also cannot be pregnant or breastfeeding during the study and must agree to use contraception or be abstinent during the treatment and for a certain amount of time afterwards (180 days for olaparib and chemotherapy; 120 days for pembrolizumab). Additionally, you cannot donate eggs during this time.
You have received certain chemotherapy drugs called anthracycline and/or taxane as part of your cancer treatment before, unless you were not able to receive them or your doctor thought it was not the best option for you.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
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?
Met criteria100.0%
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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