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Moved Trodelvy into first-line use for triple-negative patients who cannot receive immunotherapy.
ASCENT-03, trial NCT05382299 sponsored by Gilead and reported at ESMO 2025, moved sacituzumab govitecan into first-line use for metastatic triple-negative breast cancer patients who cannot receive PD-1 inhibitors. It randomised 558 patients to sacituzumab govitecan or chemotherapy, met its primary progression-free survival endpoint by blinded review, and led to FDA approval of first-line monotherapy in 2026, with overall survival immature at the first analysis and crossover to sacituzumab permitted on progression. OnCo links it to triple-negative breast cancer, sacituzumab govitecan, the TNBC and TROP2 ADC roadmaps and the ASCENT paper, and it is consistent with ASCENT and with TROPION-Breast02, which tested datopotamab deruxtecan in the same population. How to choose between the two TROP2 ADCs, which have never been compared directly, is the open question.
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.
Immature at the primary analysis; crossover to sacituzumab permitted on progression.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Sacituzumab govitecan | 279 | 9.7 months | 0.62 (0.5 to 0.77) | <0.0001 | link |
| Chemotherapy (TPC) | 279 | 6.9 months | ||||
| Objective response rate | Sacituzumab govitecan | - | 48% | - | - | - |
| Chemotherapy (TPC) | - | 44% | ||||
| Overall survival | Sacituzumab govitecan | - | Immature at the primary analysis; crossover to sacituzumab permitted on progression. | - | - | - |
| Chemotherapy (TPC) | - | - |
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.