Sacituzumab Govitecan in Primary HER2-negative Breast Cancer
Status:
Recruiting
Trial end date:
2028-12-01
Target enrollment:
Participant gender:
Summary
Phase III, prospective, multi-center, randomized, open label, parallel group, study in
patients with HER2-negative breast cancer with residual disease after neoadjuvant
chemotherapy with 1:1 allocation to:
- Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
- Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based
chemotherapy for eight cycles or observation.
Treatment in either arm will be given for eight cycles.
In patients with HR-positive breast cancer, endocrine-based therapy will be administered
according to local guidelines. The start of endocrine therapy will be at the discretion of
the investigator; however, it will be encouraged to start after surgery/radiotherapy in
patients without additional cytotoxic agents.