Pembrolizumab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerPembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if adding immunotherapy to chemotherapy can help control hormone receptor positive breast cancer that has spread.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: 2 years

2 years
Duration of Response
Efficacy in Patients Receiving Pembrolizumab after Progression on Eribulin Mesylate
Heart rate
Incidence Rate of each Toxicity (safety and tolerability).
Objective Response Rate
Overall Survival Rate
Progression Free Survival
Mesylates
27 weeks
Clinical Benefit Rate
Month 18
Clinical Benefit Rate (CBR)
Number of Participants With Grade 3 or Higher Treatment-Related Toxicity
Objective Response Rate (ORR)
Week 3
Median Duration of Response (DOR)
Month 19
Median Overall Survival (OS)
Median Progression Free Survival (PFS)

Trial Safety

Safety Progress

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

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

2 Treatment Groups

Eribulin Mesylate
1 of 2
Eribulin Mesylate Combine with Pembrolizumab
1 of 2

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Eribulin Mesylate
Drug
Experimental Group · 1 Intervention: Eribulin Mesylate · Intervention Types: Drug
Eribulin Mesylate Combine with PembrolizumabExperimental Group · 2 Interventions: Eribulin Mesylate, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,708 Total Patients Enrolled
134 Trials studying Breast Cancer
21,578 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,676 Previous Clinical Trials
4,955,680 Total Patients Enrolled
52 Trials studying Breast Cancer
6,811 Patients Enrolled for Breast Cancer
Sara Tolaney, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
102 Total Patients Enrolled
3 Trials studying Breast Cancer
102 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:
In order to be eligible for study participation, patients must have histologically or cytologically confirmed Stage IV invasive breast cancer
Subjects with at least one lesion that is not within a previously radiated field must have a CT or MRI scan to determine if the lesion has progressed since radiation therapy.
Participants are allowed to have received up to 2 prior lines of chemotherapy in the metastatic setting
The person must not have taken any biologic or investigational therapy in the past 21 days before starting the new therapy.
The patient must discontinue all hormonal therapy at least 14 days before starting the study's treatment
The participants must have received or been intolerant to at least two lines of hormonal therapies (including the adjuvant or metastatic setting) or be appropriate candidates for chemotherapy.
People in this study may have received radiation therapy in the past, either to treat their metastatic cancer or an earlier stage of cancer
The participants must have a specific type of breast cancer- HR positive, HER2-negative- in order to partake in the study
Patients must discontinue any prior targeted therapy ≥ 14 days before the first dose of study therapy.
People who are taking bisphosphonates or denosumab may continue to do so during the course of the study.