Spots Global Cancer Trial Database for Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients

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Trial Identification

Brief Title: Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients

Official Title: Engaging the Immune System to Improve the Efficacy of Neoadjuvant Chemo-endocrine Therapy for Premenopausal Luminal B Breast Cancer Patients

Study ID: NCT04659551

Conditions

Breast Cancer

Interventions

Study Description

Brief 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.

Detailed Description: This is a multicenter, phase II neoadjuvant trial in hormone-sensitive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients will undergo a core-biopsy of the primary tumor, for the histological diagnosis and the biological characterization of the tumor. After confirmation of eligibility and informed consent signature, the patients will start neoadjuvant treatment including: Epirubicin 90 mg/mq + Cyclophosphamide 600 mg/mq i.v. every 3 weeks for 3 courses, followed by the combination of Nivolumab (240 mg flat dose i.v. each 2 weeks) for 8 courses and exemestane 25 mg (orally, continuous daily dose, to be continued until surgery). Patients will start LHRH analogue (Triptorelin 3.75mg 1 fl i.m. every 28 days) concomitantly to anthracycline-based chemotherapy, to be continued until surgery.