OnCo
trialsTrialActive

ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)

Tests whether giving a TROP2 ADC after surgery can cure more of the triple-negative patients whose cancer survived pre-surgery chemo-immunotherapy.

International randomised phase 3 in the highest-risk curable TNBC population: residual disease (non-pCR) after KEYNOTE-522-type neoadjuvant therapy. Primary endpoint invasive disease-free survival. If positive, it would be the first ADC in the curative TNBC setting and the KATHERINE moment for TNBC. Readout is event-driven; our estimate is 2027.

Setting
Stage II–III TNBC with residual invasive disease after neoadjuvant therapy and surgery: adjuvant sacituzumab govitecan + pembrolizumab vs pembrolizumab ± capecitabine
Phase
Phase 3
Sponsor
Gilead / Alliance Foundation Trials
Registry
Enrolled
1514
Replication
Ongoing; no results.

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