Conditions: Estrogen Receptor Positive Tumor Breast Cancer
Keywords: Estrogen Receptor-Positive Early Stage Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 77
Healthy volunteers: no

Brief summary:
This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: eribulin mesylate intervention 2: capecitabine
Intervention descriptions: intervention 1: Cohort I \& II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles intervention 2: Cohort 1: capecitabine 900 mg/m2 orally twice daily on Days 1 - 14 of a 21-day cycle for 4 cycles Cohort II: fixed dose of 1500 mg oral capecitabine twice daily, 7 days on then 7 days off for 4 cycles

Protocol document: