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Microtubule Inhibitor

Pembrolizumab for Breast Cancer

Phase 2
Waitlist Available
Led By Sara Tolaney, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biphosphonates/Denosumab: Participants on bisphosphonates/denosumab may continue receiving bisphosphonate therapy during study treatment.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
If you are taking medication called bisphosphonates or denosumab, you can still participate in the study and continue taking those medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Progression Free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Median Duration of Response (DOR)
Median Overall Survival (OS)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Eribulin Mesylate Combine with PembrolizumabExperimental Treatment2 Interventions
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.
Group II: Eribulin MesylateExperimental Treatment1 Intervention
-Eribulin mesylate will be administered on Days 1 and 8 of each 21 day cycle for 1.4mg/m^2 intravenously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin Mesylate
2014
Completed Phase 4
~3410
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,610 Total Patients Enrolled
57 Trials studying Breast Cancer
7,366 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,316 Total Patients Enrolled
140 Trials studying Breast Cancer
22,481 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

Media Library

Eribulin Mesylate (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03051659 — Phase 2
Breast Cancer Research Study Groups: Eribulin Mesylate Combine with Pembrolizumab, Eribulin Mesylate
Breast Cancer Clinical Trial 2023: Eribulin Mesylate Highlights & Side Effects. Trial Name: NCT03051659 — Phase 2
Eribulin Mesylate (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03051659 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects have been observed in patients who take Pembrolizumab?

"Given the Phase 2 status of Pembrolizumab, our team at Power rated its safety as a 2. This score is based on existing data that confirms it has some level of safety but no evidence yet to support efficacy."

Answered by AI

What is the aggregate amount of individuals partaking in this experiment?

"Currently, this trial is not enrolling new patients. It was first posted on March 22nd 2017 and last modified April 18th 2022. For individuals hoping to explore other options, there are 2600 different studies involving breast cancer currently recruiting participants as well as 995 clinical trials examining the efficacy of Pembrolizumab."

Answered by AI

What goals is this research attempting to accomplish?

"This trial's primary aim is to measure Progression Free Survival. Secondary goals include assessing the Objective Response Rate and determining the safety and efficacy of pembrolizumab after progression on eribulin mesylate monotherapy. Disease assessments are conducted every 3 weeks for 18 cycles, while follow-up data collection will last up to 10.5 months with a range between 0.43 - 19 months. ORR is determined by complete disappearance or at least 30% decrease in target lesions per RECIST 1.1 criteria respectively; Overall response must meet incomplete/stable disease requirements for non-target lesions and no new lesion development as"

Answered by AI

Is participation in this scientific investigation still available?

"According to the records on clinicaltrials.gov, this medical experiment is no longer recruiting participants; the first posting was made on March 22nd 2017 and it has since been updated for the last time on April 18th 2022. Nevertheless, there are 3595 other studies that may be seeking volunteers right now."

Answered by AI

What other research has been carried out regarding the efficacy of Pembrolizumab?

"At the moment, 995 studies concerning Pembrolizumab are being conducted; 132 of those experiments are in Phase 3. Although Houston, Texas is where most trials take place, there are 36946 seperate locations running investigations into this particular treatment."

Answered by AI

What maladies are often remedied with Pembrolizumab?

"Pembrolizumab can be utilized to ameliorate malignant neoplasms, unresectable melanoma, and microsatellite instability high cases."

Answered by AI
~11 spots leftby Mar 2025