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Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Completed PHASE2 INTERVENTIONAL NCT04659551

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

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

Primary Outcomes

Measure: pathological complete response (pCR)
TimeFrame: up to 7 months from enrolment
Description: ypT0ypN0

Trial Information

NCT ID

NCT04659551

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Istituto Oncologico Veneto IRCCS

Last Updated

December 15, 2025