Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03393845|
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Pembrolizumab Drug: Fulvestrant||Phase 2|
This is a non-randomized, multi-site, open-label Phase II trial for subjects with metastatic, hormone receptor positive, HER2 negative breast cancer. The study will enroll 47 patients to evaluate the anti-tumor activity of pembrolizumab with fulvestrant as measured by RECIST 1.1 tumor response and by progression free survival. We expect that if the immune response is augmented by the addition of pembrolizumab, significant change in durability of response will be noted.
Patients will be treated with pembrolizumab dosed at 200 mg intravenous infusion in combination with standard fulvestrant 500mg intramuscular injection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042|
|Actual Study Start Date :||January 29, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: Pembrolizumab + Fulvestrant
Pembrolizumab 200m IV q3W + Fulvestrant. Loading dose 500mg IV IM q2W x3 followed by 500mg IM q4W
Pembrolizumab 200mg IV, 21 day cycles
Other Name: Keytruda
Fulvestrant, 500mg IM, 28 day cycles.
- Overall Response Rate [ Time Frame: 36 months ]To evaluate the overall response rate (ORR) defined as the percentage of patiences that achieve CR, PR, or SD for a minimum of four months, of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer per RECIST version 1.1 criteria and irRECIST.
- Safety profile of pembrolizumab plus fulvestrant [ Time Frame: 36 months ]To describe the toxicity profile of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer. The toxicity profile will report all grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4
- Progression free survival [ Time Frame: 36 months ]Progression free survival is defined as the time from date of treatment start until the criteria for disease progression is met or death from any cause. PFS will be assessed by RECIST 1.1 and irRECIST
- Durable response rate [ Time Frame: 36 months ]Durable response rate is defined as the number of months that a stable disease, partial or complete response is observed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393845
|Contact: Nancy Chan, MD||1 email@example.com|
|Contact: Dylan Cregar||317-634-5842 ext firstname.lastname@example.org|
|United States, Michigan|
|Michigan State University, Breslin Cancer Center||Recruiting|
|Lansing, Michigan, United States, 48910|
|Contact: Deimante Tamkus, M.D. 517-975-9547 Deimante.Tamkus@hc.msu.edu|
|Contact: Marybeth Blythe 517.975.9535 email@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Eugene Sehi 402-559-8514 firstname.lastname@example.org|
|Principal Investigator: Pavankumar Tandra, MD|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Nancy Chan, MD 732-235-9692 email@example.com|
|Principal Investigator: Nancy Chan, MD|
|Sub-Investigator: Deborah Toppmeyer, MD|
|Principal Investigator:||Nancy Chan||Rutgers Cancer Institute of New Jersey|