Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane

Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane - Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009716

Enrollment

Registered

2013-01-07

Start date

2013-01-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced and recurrent breast cancer

Interventions

Combination therapy of Eribulin and S1

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1)histlogically or cytologically confirmed breast cancer. (2) patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence. (3) patients without history of prior treatment with eribulin and S1. (4) patients at least 20 years of age but not older than 75 at the time of informed. (5) ECOG perfomance status 0-1. (6) patients with evaluable lesion by RECIST criteria. (7) required baseline laboratory parameters (within 2 weeks before registration) WBC >3,000/mm3 , neutrophil >1,500/mm3 Plt >100,000/mm3 Hb >9.0g/dL AST and ALT <=100IU/L total bilirubin <=1.5mg/dL creatinine clearance <=60 ml/min (8) no carry-over effect or side effect that could affect the study outcome of prior treatment (without alopecia and neuropathy of grade 1). (9) written informed consent was obtained (10) with life expectancy greater than 3 months.

Exclusion criteria

Exclusion criteria: (1) with symptoms of infectious disease (2) pleural effusion, peritoneal effusion which needs drainage (3) brain metastasis with the necessity of treatment (4) patients with following serious complication 1) Ischemic heart disease and arrhythmic cardiac disease with poor control. 2) ischemic heart disease within 6 months, 3) liver cirrhosis, 4) watery diarrhea 5) interstitial pneumonia or pulmonary fibrosis by chest radiograph 6) bleeding tendency 7) another serious complication (5) patients who need to receive continuous corticosteroid administration (6) positive for HBs antigen (7) patients who treated by widespread radiation therapy (8) pregnant or nursing women (9) patients who are participating in the other clinical trial (10) patients who judged improper to entry this trial by physician

Design outcomes

Primary

Measure	Time frame
DLT;Dose Limiting Toxicity MTD;Maximum Tolerated Dose	—

Secondary

Measure	Time frame
Overall response rate, Progression free survival, Adverse Event	—

Countries

Japan

Contacts

Public ContactJunji Tsurutani

Kinki University Hospital, Faculty of medicine Depertment of medical oncology

072-366-0221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026