NCT03818685

Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease

A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in Triple Negative Breast Cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy.

Detailed description

This trial is an open-label, randomised, multicentric, comparative, Phase II study aiming to evaluate the clinical benefit of a combined treatment associating radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine (standard treatment) in early TNBC patients who have Residual cancer burden (RCB) II or III residual disease after neoadjuvant chemotherapy. Following validation of eligibility criteria, patients will be randomised (1:1) to receive: * Arm A: Nivolumab (360 mg IV, every 3 weeks) for 8 doses and Ipilimumab (1 mg/kg, IV, every 6 weeks or every 2 doses of Nivolumab in case of dose delays) for 4 doses. * Arm B: Capecitabine (1000 mg/m2 twice a day, Bis In Die \[BID\]), 14 days on / 7 days off for 8 cycles. In both arms, radiotherapy will be administered as per standard practice and has to be initiated one week before C1D1.

Conditions

• Breast Cancer
• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Nivolumab	Radiotherapy will be maintained in each Arm.
DRUG	Ipilimumab	Radiotherapy will be maintained in each Arm.
DRUG	Capecitabine	Radiotherapy will be maintained in each Arm.

Timeline

• Start date: 2019-07-02
• Primary completion: 2024-03-15
• Completion: 2024-05-01
• First posted: 2019-01-28
• Last updated: 2024-02-12

Locations

17 sites across 1 country: France