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
Effectiveness Progress
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
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
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: DrugEribulin 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.
References
- Tolaney, Sara M., Romualdo Barroso-Sousa, Tanya Keenan, Tianyu Li, Lorenzo Trippa, Ines Vaz-Luis, Gerburg Wulf, et al.. 2020. “Effect of Eribulin with or Without Pembrolizumab on Progression-free Survival for Patients with Hormone Receptor–positive, erbb2-negative Metastatic Breast Cancer”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2020.3524.
- Keenan, Tanya E., Jennifer L. Guerriero, Romualdo Barroso-Sousa, Tianyu Li, Tess O’Meara, Anita Giobbie-Hurder, Nabihah Tayob, et al.. 2021. “Molecular Correlates of Response to Eribulin and Pembrolizumab in Hormone Receptor-positive Metastatic Breast Cancer”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-021-25769-z.
- Sara Tolaney 2017. "A Randomized Phase II Study Of Eribulin Mesylate With or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03051659.
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Conditions
Cancer Related
Treatments