Adults 18 to 80, any sex, with Malignant Solid Tumour or Breast Cancer Nos Metastatic Recurrent. 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.
Maximum Tolerated Dose (MTD) in Participants With Any Solid Tumor (Phase Ib)Primary· Up to 24 months
Standard dose-confirmation design of 3 to 6 participants per cohort (3+3 design) was used to determine the MTD of eribulin in combination with cyclophosphamide for participants with any solid tumor. The highest dose level or MTD is reached when no more than one of six participants experience a Dose Limiting Toxicity (DLTs). A DLT is defined as any treatment-related toxicity in first 28 days of therapy with a grade 3 or 4 non-hematologic toxicity, a grade 4 neutropenia or thrombocytopenia lasting \>7 days or febrile neutropenia, or any clinically significant toxicity grade 2 or higher that requ
Clinical Benefit Rate for Patients With Advanced Breast Cancer (ABC) (Phase II)Primary· Up to 24 months
The clinical benefit rate is defined as the proportion of participants with confirmed complete response (CR), partial response (PR) and stable disease (SD) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Responses are determined by changes in the largest diameter of the tumor lesions and the shortest diameter in the case of malignant lymph nodes. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter, PR is defined as at least a 30% decrease in the sum of
Group
Value
95% CI
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
.135
Number of Participants With Treatment-related ToxicitiesSecondary· Up to 24 months
Safety of combination of eribulin and cyclophosphamide in participants was assessed by monitoring the frequency of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with an attribute of possibly, probably, or definitely related to treatment. Number of participants by toxicity will be reported.
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
5
Number of Participants With Dose Limiting Toxicity (DLT) for Participants With Any Solid Tumor (Phase 1b)Secondary· Up to 24 months
For the purposes of Phase Ib dose escalation, DLTs will be defined as any treatment-related toxicity occurring within the first 21 days of combination therapy as grade 3 or 4 clinically evident non-hematologic toxicity; grade 4 neutropenia or thrombocytopenia lasting \> 7 days or febrile neutropenia; or any clinically significant toxicity grade 2 or higher that requires more than 14 days to resolve.
Overall Response Rate (ORR) for Participants With Advanced Breast Cancer (Phase II)Secondary· Up to 24 months
The ORR is defined as the proportion of participants displaying a CR or PR per RECIST criteria recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response will depend on the achievement of both measurement and confirmation criteria with CR defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter and PR is defined as at least a 30% dec
Group
Value
95% CI
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
.131
Time to Progression for Participants With Advanced Breast Cancer (Phase II)Secondary· Up to 24 months
Time to progression will be evaluated as time from first treatment to tumor progression in weeks. Disease progression will be measured using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST 1.1 criteria.
Group
Value
95% CI
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
16.4
13.8 – 21.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide (Cytoxan®) given together at different doses. This study will look at what effects, good and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide has been approved for different types of cancers (including breast cancer). However, the combination of eribulin and cyclophosphamide is considered experimental; that means this combination has not been approved by the FDA.
The funding for this study is provided by Eisai Inc., the maker of eribulin.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat
· Phase 2
· not yet recruiting
NCT07461454 — YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer
· Phase 3
· not yet recruiting
NCT06957431 — Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma
· Phase 1
· recruiting
NCT06942234 — Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer
· Phase 1, PHASE2
· recruiting
NCT06102824 — Organoid-based Functional Precision Therapy for Advanced Breast Cancer
· Phase 2
· recruiting
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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 University of California, San Francisco
Last refreshed: 3 February 2021
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/NCT01554371.