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Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localized Luminal B HER2(-) and Triple Negative Breast Cancer.

NCT03356860 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-11-20

No results posted yet for this study

Summary

The study has a phase Ib and a phase II part.

* The phase Ib aims to evaluate the safety and tolerability of durvalumab in combination with a dose- dense EC regimen in a neoadjuvant setting for early breast cancer.
* The phase II aims to explore the efficacy of durvalumab in combination with a dose-dense EC regimen in a neoadjuvant setting for early breast cancer.

Conditions

Interventions

DRUG

Paclitaxel

80mg/m2 IV weekly from week 1 to week12

DRUG

Epirubicin

90 mg/m2 IV Q 2 weeks from week 14 to week 20

DRUG

Cyclophosphamide

600 mg/m2 IV Q 2 weeks from week 14 to week 20

DRUG

Durvalumab

Durvalumab 1500 mg IV at week 14 and 18

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER

  • Grand Hôpital de Charleroi

    lead OTHER

Principal Investigators

  • Javier Carrasco, MD, PhD · GHdC

  • Jean-Luc Canon, MD · GHdC

  • François Duhoux, MD, PhD · Cliniques universitaires Saint-Luc (UCL)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-13
Primary Completion
2022-11-21
Completion
2023-12-31

Countries

  • Belgium

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 NCT03356860 on ClinicalTrials.gov