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Moved Trodelvy into first-line use for triple-negative patients who cannot receive immunotherapy.
FDA reports 558 randomized patients with previously untreated unresectable locally advanced or metastatic TNBC who were not candidates for PD-1/PD-L1 therapy. Sacituzumab govitecan versus chemotherapy improved median PFS, 9.7 versus 6.9 months (HR 0.62, 95% CI 0.50 to 0.77). Overall survival was immature at approval. ClinicalTrials.gov lists 623 actual participants; the difference from the FDA efficacy-study population is retained without inventing a reconciliation. These are advanced-disease outcomes, not postoperative recurrence prevention.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
558 randomised.
95% CI 44 to 56 · 95% CI 41 to 53
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Sacituzumab govitecan | - | 9.7 months | 0.62 (0.5 to 0.77) | <0.0001 | link |
| Chemotherapy | - | 6.9 months | ||||
| Overall survival | Sacituzumab govitecan | - | Immature at FDA approval on June 24, 2026. | - | - | link |
| Chemotherapy | - | - | ||||
| Confirmed objective response rate (FDA approval analysis) | Sacituzumab govitecan | - | 50% | - | - | link |
| Chemotherapy | - | 47% |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
NCCN is the source of the category grades on the triple-negative breast cancer page and the first major guideline to place an antibody-drug conjugate first line for the disease.
The first-line overall survival result that made an antibody-drug conjugate the standard for PD-L1-negative or immunotherapy-ineligible metastatic triple-negative disease, and the reason the sequencing question (which TROP2 drug first, what after it) is now urgent.
This is the paper Europe PMC returns for registry id NCT05382299 with the most citations, so it is the natural first reading for anyone following the ASCENT-03 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Sacituzumab govitecan is a standard second-line or later treatment for metastatic triple-negative breast cancer, roughly doubling survival compared with the chemotherapies it was tested against. Patients should expect neutropenia and diarrhoea, which are manageable with growth factor support and loperamide. Trials are now testing it earlier, in first-line combinations with pembrolizumab and after surgery for residual disease.
Shares Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology, TROP2 PET to choose and sequence TROP2 ADCs, ASCENT, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line.
Shares Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology, Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial, TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line.
Shares Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares Gilead Sciences (incl. Kite), Sacituzumab govitecan, Metastatic triple-negative breast cancer, Topoisomerase-I inhibitors (and ADC payloads).
Shares TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer.
Shares Gilead Sciences (incl. Kite), Sacituzumab govitecan, Metastatic triple-negative breast cancer, Topoisomerase-I inhibitors (and ADC payloads).
Shares TROP2 PET to choose and sequence TROP2 ADCs, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Sacituzumab govitecan, Antibody-drug conjugate (ADC).
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer, Sacituzumab govitecan, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/