Pembrolizumab in Hormone Receptor-positive, hyperMUTATted Metastatic Breast Cancer Identified by Whole exOme sequeNcing ('MUTATION2')
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|ClinicalTrials.gov Identifier: NCT03492918|
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : February 8, 2019
Abbreviated Title : Pembrolizumab in hypermutated breast cancer Trial Phase : II Clinical Indication : Hormone receptor-positive metastatic breast cancer Trial Type : Interventional Type of control : None Route of administration : Intravenous Trial Blinding : None Treatment Groups : Pembrolizumab Number of trial subjects : Approximately 150 patients will be prescreened with whole exome sequencing. Then 30 patients will be enrolled in the treatment phase.
Estimated enrollment period : 12 months Estimated duration of trial : The sponsor estimates that the trial will require approximately 24 months from the time the first subject signs the informed consent until the last subject's last visit.
Duration of Participation : 12 months Estimated average length of treatment per patient : 8 months
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pembrolizumab in Hormone Receptor-positive, hyperMUTATted Metastatic Breast Cancer Identified by Whole exOme sequeNcing ('MUTATION2')|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: pembrolizumab group
Drug:Pembrolizumab Dose/Potency:200 mg Dose Frequency:Q3W Route of Administration:IV infusion Regimen/Treatment Period:Day 1 of each 3 week cycle Use:Experimental
Trial treatment should be administered on Day 1 of each cycle after all procedures/assessments have been completed as detailed on the Trial Flow Chart. Trial treatment may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons.
All trial treatments will be administered on an outpatient basis. Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Other Name: Keytruda
- Change of objective response rate(ORR) by RECIST 1.1 [ Time Frame: Every 3 cycles (each cycle is 21 days) ]Objective response rate (ORR) based on RECIST 1.1 in hormone receptor-positive, hypermutated metastatic breast cancer identified by whole exome sequencing (WES) Hypothesis: Pembrolizumab in patients with hormone receptor-positive, hypermutated metastatic breast cancer identified by WES will result in clinically meaningful ORR based on RECIST 1.1
- Clinical benefit rate(CBR) by RECIST 1.1 [ Time Frame: through study completion, an average of 1 year ]
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): NCT03492918
|Korea, Republic of|
|Yonsei Cancer Center at Yonsei University Health System||Not yet recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Joo Hyuk Sohn, MD, PhD 82-2-2228-8135 firstname.lastname@example.org|