At a glance
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Engaging the Immune System to Improve the Efficacy of Neoadjuvant Chemo-endocrine Therapy for Premenopausal Luminal B Breast Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Epirubicin, Cyclophosphamide, and 3 other interventions for Breast Cancer. Completed, enrolled 43 participants across 5 sites.
Detailed Summary
Multicentric, phase II neoadjuvant trial in hormone-positive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients receive as neoadjuvant treatment before surgery: three courses of anthracycline-based chemotherapy followed by exemestane p.o. daily plus nivolumab i.v. 2-weekly for 8 courses. GnRH analogues are started concomitantly with chemotherapy and maintained until the completion of neoadjuvant treatment.
Study Details
Timeline
Interventions
Epirubicin 90 mg/mq i.v. every 3 weeks for three cycles
Cyclophosphamid 600 mg/mq i.v. every 3 weeks for three cycles
Triptorelin 3.75 mg i.m. every 4 weeks until surgery
Exemestane 25 mg oral continuous daily dose until surgery
Nivolumab 240 mg flat dose i.v. every two weeks for 8 cycles