Pre-operAtive Non-Anthracycline Chemotherapy, Durvalumab +/- RAdiation Therapy in Triple Negative Breast Cancer
Status:
Withdrawn
Trial end date:
2027-07-01
Target enrollment:
Participant gender:
Summary
This phase II randomized trial is for patients with clinical stage II-III, ER and PR <10%,
HER2-negative invasive breast carcinoma (triple negative breast cancer) for whom adjuvant RT
is planned and pre-operative RT is deemed feasible by the treating radiation oncologist.
Subjects will be randomized into arm A or B and treatment will last for 16 weeks. Both groups
will receive Durvalumab 750mg IV Q2 weeks x 2 then a biopsy prior to durvalumab 1500mg IV Q4
weeks x 3 with paclitaxel and carboplatin IV weekly x 12. Arm B will receive radiation (24 Gy
total) starting with the second durvalumab dose every other day (8Gy per fraction) for one
week. Following treatment, subjects will receive SOC breast surgery and continue on to
physician's choices SOC treatment during the 3 year follow up period.
This study hopes to explore the impact of checkpoint blockade administration with a non-
anthracycline chemotherapy regimen plus RT on post-surgery pathologic complete response (pCR)
rate in the breast and axilla (ypT0/Tis ypN0) following 12 weeks of treatment and surgery.