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

Sponsor
Grand Hôpital de Charleroi
Study ID
NCT03356860
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    80mg/m2 IV weekly from week 1 to week12
  • Epirubicin — DRUG
    90 mg/m2 IV Q 2 weeks from week 14 to week 20
  • Cyclophosphamide — DRUG
    600 mg/m2 IV Q 2 weeks from week 14 to week 20
  • Durvalumab — DRUG
    Durvalumab 1500 mg IV at week 14 and 18

Study Details

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.

Key Dates

Start date
Apr 13, 2017
Status verified
Nov 2024
Primary completion
Nov 21, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab
    Patients will received paclitaxel 80 mg/m2 IV weekly from week 1 to 12 and then an association of epirubicin 90 mg/m2 IV and cyclophosphamide 600 mg/m2 IV Q 2 weeks from week 14 to 20. Durvalumab will be administered at 1500 mg IV at week 14 and week 18.
  • Active Comparator: Standard
    Patients will received paclitaxel 80 mg/m2 IV weekly from week 1 to 12 and then an association of epirubicin 90 mg/m2 IV and cyclophosphamide 600 mg/m2 IV Q 2 weeks from week 14 to 20.

Primary Outcome Measure

Adverse events [ Time Frame: 74 weeks ]

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