Phase III postneoadjuvant study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment - SASCIA
Study of the German Breast Group (GBG) in collaboration with the AGO-B
Phase III, prospective, multi-center, randomized, open label, parallel group, study evaluating activity of sacituzumab govitecan in HER2-negative patients at high risk of relapse after NACT.
A total of 1200 patients will be enrolled in the study.
Recruiting has started.
The first patient was recruited on November 6th, 2020.
Prospective, multi-center, randomized, open label, parallel group, phase III with 1:1 allocation to:
Arm A: Sacituzumab govitecan (days 1, 8 q3w);
Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy or observation. The latter would include adjuvant endocrine therapy according to local guidelines for HR-positive patients).
Treatment in either arm will be given for eight cycles.
Endocrine therapy will be administered according to local guidelines for HR-positive patients. 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. In patients receiving either sacituzumab govitecan or active TPC, endocrine therapy should start thereafter.
All patients received neoadjuvant chemotherapy and had residual disease.
Inclusion and exclusion criteria and detailed study information are available in the documents below.
The following documents are availbale for download
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