Study on the clinical efficacy of Eribulin as the first- or second-line treatment in patients with recurrent HER2- negative breast cancer (randomized Phase II study)(JBCRG-19)

Phase 2

• Conditions: Patients with recurrent HER2-negative breast cancer with a history of neoadjuvant or adjuvant therapy with anthracyclines and taxanes with no or one prior metastatic breast cancer chemotherapy regimens. Prior hormonal therapy for metastatic breast cancer is permitted.

• Registration Number: JPRN-UMIN000009886
• Lead Sponsor: JBCRG(Japan Breast Cancer Research Group)

Brief Summary

Results The median PFS was 6.6 months with eribulin versus 4.2 months with TPC (hazard ratio: 0.72 [95% confidence interval (CI), 0.40-1.30], p = 0.276). Median TTF was 6.0 months with eribulin versus 3.6 months with TPC (hazard ratio: 0.66 [95% CI, 0.39-1.14], p = 0.136). Other endpoints were also similar between groups. Conclusions Eribulin seemed to improve PFS or TTF compared with TPC without statistical significance. Further validation studies are needed.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-01
• Study Completion: 2018-11-10
• Results First Posted: 2021-06-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with infectious complications, or with a fever and suspected infection. 2) Patients with a severe drug allergy. 3) Patients with severe renal impairment or hepatic dysfunction (jaundice). 4) Patients with clear interstitial pneumonia or pulmonary fibrosis on chest X-ray. 5) Patients with a large amount of pleural effusion or ascites (patients who need drainage) 6) Patients with poorly controlled hypertension or diabetes. 7) Patients who have undergone continuous and systemic administration of steroids (oral or intravenous). 8) Pregnant patients or patients who may be pregnant. 9) Active multiple primary cancers. 10) Patients with a history of a psychiatric disorder that causes a clinical problem, or a central nervous system disorder. 11) Patients with active brain metastasis. 12) Patients who are receiving another treatment at the time. 13) Patients who are judged to be unsuitable as a subject of the treatment by the investigator (subinvestigator) (including those with significant disease progression or cases that are likely to develop a life-threatening condition if a response is not immediately obtained).

Study & Design

• Study Type: Interventional
• Study Design: Not specified