18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Progression Free Survival (PFS)Primary· 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.
Group
Value
95% CI
Eribulin Mesylate
4.2
3.7 – 6.1
Eribulin Mesylate Combine With Pembrolizumab
4.1
3.5 – 6.2
Objective Response Rate (ORR)Secondary· 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.
Group
Value
95% CI
Eribulin Mesylate
34
20.5 – 49.9
Eribulin Mesylate Combine With Pembrolizumab
27
14.9 – 42.8
Median Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Eribulin Mesylate
12.5
8.6 – NA
Eribulin Mesylate Combine With Pembrolizumab
13.4
10.4 – NA
Median Duration of Response (DOR)Secondary· 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.
Group
Value
95% CI
Eribulin Mesylate
2.1
1.0 – 4.6
Eribulin Mesylate Combine With Pembrolizumab
0.6
0 – 1.0
Clinical Benefit Rate (CBR)Secondary· 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.
Group
Value
95% CI
Eribulin Mesylate
21
Eribulin Mesylate Combine With Pembrolizumab
22
Number of Participants With Grade 3 or Higher Treatment-Related ToxicitySecondary· 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.
Group
Value
95% CI
Eribulin Mesylate
44
Eribulin Mesylate Combine With Pembrolizumab
44
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Eribulin Mesylate Combine With Pembrolizumab
Serious: 27/44 (61%)
Deaths: 19/44
Eribulin Mesylate
Serious: 25/44 (57%)
Deaths: 21/44
Serious adverse events (44 terms)
Reaction
System
Eribulin Mesylate Combine …
Eribulin Mesylate
Neutrophil count decreased
Investigations
—
—
Aspartate aminotransferase increased
Investigations
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Alanine aminotransferase increased
Investigations
—
—
Hypokalemia
Metabolism and nutrition disorders
—
—
Peripheral sensory neuropathy
Nervous system disorders
—
—
Alkaline phosphatase increased
Investigations
—
—
Anemia
Blood and lymphatic system disorders
—
—
Fatigue
General disorders
—
—
Hyperglycemia
Metabolism and nutrition disorders
—
—
Lung infection
Infections and infestations
—
—
Mucositis oral
Gastrointestinal disorders
—
—
White blood cell decreased
Investigations
—
—
Colitis
Gastrointestinal disorders
—
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
—
Hypotension
Vascular disorders
—
—
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
—
—
Thromboembolic event
Vascular disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Anorexia
Metabolism and nutrition disorders
—
—
Blood bilirubin increased
Investigations
—
—
Cardiac disorders - Other, specify
Cardiac disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Other adverse events (138 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06590558 — Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Er
· Phase 1
· withdrawn
NCT05041101 — Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer
· Phase 1, PHASE2
· terminated
NCT04579224 — Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothel
· Phase 3
· active not recruiting
NCT04345913 — Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer
· Phase 1, PHASE2
· active not recruiting
NCT05206656 — Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
· Phase 2
· completed
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
NCT06148038 — CBD for Breast Cancer Primary Tumors
· Phase 1
· recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R
· Phase 2
· recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
· Phase 2
· recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
· NA
· recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
· Phase 2
· recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 6 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03051659.