Breast Cancer · Medical · Relapsed / Refractory

ASCENT

In previously treated metastatic triple-negative breast cancer, does sacituzumab govitecan improve outcomes compared with physician's-choice chemotherapy?

Trial design and population

Population / eligibility

529 patients were randomized; the primary efficacy population comprised 468 patients with relapsed/refractory metastatic TNBC after at least two prior systemic therapies, including ≥1 for metastatic disease, and excluded brain metastases.

Intervention vs comparator

Sacituzumab govitecan 10 mg/kg IV days 1 and 8 every 21 days vs eribulin, vinorelbine, capecitabine or gemcitabine.

Sample size

529 randomized; primary efficacy population 468

Primary endpoint

PFS and OS

Key results

Final analysis: median PFS 4.8 vs 1.7 months (HR 0.41, 95% CI 0.33–0.52); median OS 11.8 vs 6.9 months (HR 0.51, 95% CI 0.42–0.63).

Source-reported outcome visualization

Median overall survival · Final analysis

Sacituzumab govitecan

11.8 months

Physician's choice

6.9 months

Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.

Absolute Effect

Median OS difference 4.9 months is not a fixed-time absolute risk difference; no NNT is calculated from medians.

NNT: Not calculated; median OS difference is not a valid NNT. Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.

NNH: Not quantifiable. Grade ≥3 neutropenia was common (about 51%) and grade ≥3 diarrhoea about 10%; febrile neutropenia and discontinuation require attention. UGT1A1*28 may increase neutropenia risk.

Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.

Safety and treatment burden

Grade ≥3 neutropenia was common (about 51%) and grade ≥3 diarrhoea about 10%; febrile neutropenia and discontinuation require attention. UGT1A1*28 may increase neutropenia risk.

Follow-up, maturity and limitations

Follow-up: Final efficacy analysis published 2024.

Primary efficacy population excluded active brain metastases. Treatment sequence depends on prior therapies and current standards; myelosuppression and diarrhoea require proactive supportive care.

Clinical interpretation

Sacituzumab govitecan markedly improves PFS and OS over single-agent chemotherapy in previously treated metastatic TNBC.

Current-practice context · reviewed 20 October 2026

This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.

Primary and authoritative sources

Bardia A, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial. JCO. 2024. Source ↗

ClinicalTrials.gov NCT02574455 Source ↗