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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03818685
Study type Interventional
Source Centre Leon Berard
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 2, 2019
Completion date May 1, 2024

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