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

NCT04659551 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-12-09

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Principal Investigators

  • Pierfranco Conte, MD · University of Padova

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2020-05-25
Completion
2020-05-25

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659551 on ClinicalTrials.gov