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

Sponsor
Centre Leon Berard
Study ID
NCT03818685
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Radiotherapy will be maintained in each Arm.
  • Ipilimumab — DRUG
    Radiotherapy will be maintained in each Arm.
  • Capecitabine — DRUG
    Radiotherapy will be maintained in each Arm.

Study Details

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.

Key Dates

Start date
Jul 2, 2019
Status verified
Feb 2024
Primary completion
Mar 15, 2024
Completion
May 1, 2024

Study Design

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

Arms

  • Experimental: Nivolumab + Ipilimumab
    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.
  • Active Comparator: Capecitabine
    Capecitabine (1000 mg/m2 twice a day, Bis In Die), 14 days on / 7 days off for 8 cycles.

Primary Outcome Measure

Disease free survival (DFS) [ Time Frame: At 2 years ]

Related Studies