Conditions: HER2 Negative Breast Cancer
Keywords: breast cancer eribulin Halaven taxotere
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 76
Healthy volunteers: no

Brief summary:
The investigators propose a randomized phase II study evaluating the pCR and toxicity profiles of combination eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC) as neoadjuvant therapy for locally advanced HER2-negative breast cancer.

Detailed description:

Arms:
arm 1: Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard arm 2: Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard

Interventions: intervention 1: Eribulin intervention 2: Cyclophosphamide intervention 3: Docetaxel
Intervention descriptions: intervention 1: 1.4 mg/m2 IV (Days 1 \& 8), given short (≤15 minute) IV infusion, per institutional standard intervention 2: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard. intervention 3: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks.

Protocol document: