NCT04659551

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Epirubicin	Epirubicin 90 mg/mq i.v. every 3 weeks for three cycles
DRUG	Cyclophosphamide	Cyclophosphamid 600 mg/mq i.v. every 3 weeks for three cycles
DRUG	Triptorelin	Triptorelin 3.75 mg i.m. every 4 weeks until surgery
DRUG	Exemestane	Exemestane 25 mg oral continuous daily dose until surgery
DRUG	Nivolumab	Nivolumab 240 mg flat dose i.v. every two weeks for 8 cycles

Timeline

• Start date: 2017-10-05
• Primary completion: 2020-05-25
• Completion: 2020-05-25
• First posted: 2020-12-09
• Last updated: 2020-12-09

Locations

5 sites across 1 country: Italy