NCT03356860

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

A Phase IB/II Study of Durvalumab (MEDI4736) Combined With Dose-dense EC in a Neoadjuvant Setting for Patients With Locally Advanced Luminal B HER2(-) or Triple Negative Breast Cancers.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Grand Hôpital de Charleroi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer
• Triple Negative Breast Cancer
• Luminal B

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-13
• Primary completion: 2022-11-21
• Completion: 2023-12-31
• First posted: 2017-11-29
• Last updated: 2024-11-20

Locations

4 sites across 1 country: Belgium