Phase I Clinical Study of Combination Therapy with Eribulin and Capecitabine in Patients with Progressive Recurring Breast Cancer(JBCRG-18Cape)

Phase 1

• Conditions: Progressive Recurring Breast Cancer

• Registration Number: JPRN-UMIN000009611
• Lead Sponsor: JBCRG (Japan Breast Cancer Research Group)

Brief Summary

Results One patient had grade 4 DLTs at level 0 (Cr 7.65 mg/dL and UA 13.4 mg/dL), considered associated with study drugs. Level 1 dosing was taken as the RD. Of three patients in level 1, one achieved PR and one had prolonged SD. Conclusions Eribulin with capecitabine in the level 1 dosing schedule was associated with manageable toxicities and promising clinical activity. This combination is recommended for phase II investigation.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-26
• Study Completion: 2014-11-30
• Results First Posted: 2018-01-25
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who were administered with capecitabine in the treatment immediately prior to this clinical study. 2) Patients with coexisting infection or cases with pyrexia suspected of infection. 3) Patients with serious drug allergy. 4) Patients with serious renal disorder and hepatic disorder (jaundice). 5) Patients with clear indications of interstitial pneumonia or pulmonary fibrosis in chest X-ray. 6) Patients with large pleural/peritoneal effusion (patients required drainage) 7) Patients with poorly-controlled hypertension and diabetes mellitus. 8) Patients with continuous systemic administration (oral or intravenous) of steroid. 9) Pregnant patients or cases with possible pregnancy. 10) Patients with active multiple primary cancer. 11) Cases with preexisting condition of psychiatric disorder or central nervous system disorder. 12) Patients with active brain metastasis. 13) Patients participating in other clinical study. 14) Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study. 15) Patients with hepatitis B antibody.

Study & Design

• Study Type: Interventional
• Study Design: Not specified