A Randomized Phase II Study Of Eribulin Mesylate With or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer
- Registration Number
- NCT03051659
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic hormone receptor positive breast cancer.
- Detailed Description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
In this research study, The investigators are evaluating the safety and effectiveness of Eribulin mesylate with or without Pembrolizumab in metastatic hormone receptor positive breast cancer.
The FDA (the U.S. Food and Drug Administration) has not approved the combination of Pembrolizumab and Eribulin mesylate for Breast Cancer.
The FDA has not approved Pembrolizumab for this specific type of breast cancer but it has been approved in the United States for other diseases.
The FDA has approved Eribulin mesylate as a treatment option for this type of breast cancer.
Pembrolizumab is a medicine that may treat cancer by working with the immune system. The immune system is the body's natural defense against disease. The immune system sends types of cells called "T cells" throughout the body to detect and fight infections and diseases, including cancer. For some types of cancer, the T cells do not work as they should and are prevented from attacking the tumors. Pembrolizumab is thought to work by blocking a protein in the T cells called PD-1 ("programmed death 1"), which then may allow these cells and other parts of the immune system to attack tumors.
Eribulin mesylate is developed from a natural substance found in a sea sponge. Eribulin mesylate works by preventing cancer cells from multiplying.
The combination of Pembrolizumab and Eribulin mesylate is investigational. The study drugs, when given separately, work in different ways to stop the cancer cells from growing and spreading. However, it is not known if giving the two study drugs at the same time will have a better anti-cancer effect than giving each treatment on its own.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eribulin Mesylate Eribulin Mesylate -Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4mg/m\^2 intravenously. Eribulin Mesylate Combine with Pembrolizumab Pembrolizumab * Pembrolizumab will be administered in clinic once per cycle, given 200mg/m\^2 intravenously prior to Eribulin Mesylate. * Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4 mg/m\^2 intravenously. Eribulin Mesylate Combine with Pembrolizumab Eribulin Mesylate * Pembrolizumab will be administered in clinic once per cycle, given 200mg/m\^2 intravenously prior to Eribulin Mesylate. * Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4 mg/m\^2 intravenously.
- Primary Outcome Measures
Name Time Method Median Progression Free Survival (PFS) Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. Median follow-up 10.5 months with range 0.43-19 months. Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. If after Cycle 18 scans, a participant has SD or better by RECIST the frequency of assessments may be reduced to every 4 cycles, up to a maximum of 18 months. The objective response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Median Duration of Response (DOR) Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. If after Cycle 18 scans, a participant has SD or better by RECIST the frequency of assessments may be reduced to every 4 cycles. DOR is defined as the time from CR or PR achieved until renewed disease progression is detected. DOR will be calculated per RECIST 1.1 and irRECIST criteria.
Median Overall Survival (OS) Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. Median follow-up 10.5 months with range 0.43-19 months. OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. Patients who discontinued treatment to pursue potentially curative resection were censored for progression-free survival at the time of surgery. Patients who had not experienced cancer progression or died were censored at their last known follow-up date.
Clinical Benefit Rate (CBR) Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. If after Cycle 18 scans, a participant has SD or better by RECIST the frequency of assessments may be reduced to every 4 cycles, up to a maximum of 18 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Number of Participants With Grade 3 or Higher Treatment-Related Toxicity Disease assessments is performed every 3 cycles (3 weeks/cycle) for the first 18 cycles. If after Cycle 18 scans, a participant has SD or better by RECIST the frequency of assessments may be reduced to every 4 cycles, up to a maximum of 18 months. All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
Trial Locations
- Locations (3)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States