NCT01401959

Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.

Detailed description

This is a non-randomized, open-label trial to evaluate 6 cycles of eribulin in female patients with invasive breast cancer who do not achieve pathologic complete response (pCR) after treatment with a standard neoadjuvant chemotherapy and surgery regimen. Patients will be randomized into three cohorts according to tumor-type: triple-negative (Cohort A), hormone-receptor-positive/HER2-negative (Cohort B), and HER2-positive (Cohort C) tumors. Patients will receive eribulin for 6 cycles (1 cycle = 21 days). Patients with HER2-positive tumors will also receive trastuzumab. Patients in all cohorts will be allowed to receive locoregional radiotherapy and/or adjuvant hormonal therapy per institutional guidelines.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin	1.4 mg/m\^2 IV Days 1 and 8, every 21 days for six cycles
DRUG	Trastuzumab	6 mg/kg IV Day 1 every 21 days

Timeline

• Start date: 2011-09-23
• Primary completion: 2017-04-03
• Completion: 2017-04-03
• First posted: 2011-07-26
• Last updated: 2018-06-15
• Results posted: 2018-05-07

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study