Every pivotal FDA-registration trial in metastatic triple-negative breast cancer — approval dates, biomarker & companion-diagnostic wording, and PFS/OS — with each figure traced to a live primary source.
| FDA date | Drug / trial | Population / comparator | Biomarker & companion Dx | Median PFS | Median OS | FDA action / status | Pub. |
|---|---|---|---|---|---|---|---|
| 2026-06-24 | Sacituzumab govitecan (Trodelvy) + pembrolizumab ASCENT-04 / KEYNOTE-D19 · NCT05382286 Gilead Sciences · N=443 · 1L |
Previously untreated PD-L1-positive locally advanced unresectable/metastatic TNBC vs Pembrolizumab + chemo (physician's choice) |
PD-L1 CPS ≥10 Label: PD-L1 (CPS ≥10) "as determined by an FDA-authorized test" (22C3 pharmDx). SG is Trop-2-directed (no Trop-2 test). |
11.2 vs 7.8 mo, HR 0.65 (95% CI 0.51–0.84, P<0.001) | Immature at analysis | Approved 1L mTNBC, PD-L1 CPS≥10 (SG + pembrolizumab) ACTIVE – NEW 1L combination indication |
Tolaney SM et al. N Engl J Med 2026;394:354–66 (PMID 41564397) |
| 2026-06-24 | Sacituzumab govitecan (Trodelvy) monotherapy ASCENT-03 · NCT05382299 Gilead Sciences · N=558 randomized (623 registered) · 1L |
Previously untreated advanced TNBC, not candidates for PD-1/PD-L1 inhibitors vs Chemo (paclitaxel/nab-paclitaxel/gem-carbo) |
None required (Trop-2 ADC; enrolled CPS<10 and IO-ineligible CPS≥10) No companion diagnostic. Clinical eligibility: "not candidates for PD-1 or PD-L1 inhibitor-based therapy." |
9.7 vs 6.9 mo, HR 0.62 (95% CI 0.50–0.77, P<0.001) | Immature at analysis | Approved 1L mTNBC single agent (PD-1/PD-L1-ineligible) ACTIVE – NEW 1L single-agent indication |
Cortés J et al. N Engl J Med 2025;393:1912–25 (PMID 41124233) |
| 2026-05-22 | Datopotamab deruxtecan (Datroway) TROPION-Breast02 · NCT05374512 AstraZeneca / Daiichi Sankyo · N=644 · 1L |
Previously untreated locally recurrent inoperable/metastatic TNBC, immunotherapy not an option vs Chemo (investigator's choice) |
None required (Trop-2 ADC; stratified by PD-L1 status) No companion diagnostic. Clinical eligibility: "not candidates for PD-1/PD-L1 inhibitor therapy." |
10.8 vs 5.6 mo, HR 0.57 (99% CI 0.44–0.73, P<0.0001) | 23.7 vs 18.7 mo, HR 0.79 (95.01% CI 0.64–0.98, P=0.029) — significant | Approved 1L mTNBC (PD-1/PD-L1-ineligible) ACTIVE – NEW 1L single-agent indication (2nd Trop-2 ADC in this setting) |
Dent R et al. Ann Oncol 2026 (PMID 41937088) |
| 2022-08-05 | Trastuzumab deruxtecan (Enhertu) DESTINY-Breast04 · NCT03734029 AstraZeneca / Daiichi Sankyo · N=557 (63 HR-negative, 11.3%) · 2L+ (post-chemo) |
HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer; small HR-negative cohort is the TNBC-relevant slice vs Chemo (physician's choice: eribulin/capecitabine/gemcitabine/paclitaxel/nab-pac) |
HER2-low (IHC 1+ or IHC 2+/ISH-) Label: HER2-low "as determined by an FDA-authorized test" (HER2 IHC, e.g. PATHWAY/VENTANA & HercepTest). Reclassifies ~60% of traditional TNBC out of the TNBC-ADC pathway. |
All pts 9.9 vs 5.1 mo, HR 0.50 (P<0.001); HR-negative subgroup 8.5 vs 2.9 mo, HR 0.46 (exploratory) | All pts 23.4 vs 16.8 mo, HR 0.64; HR-negative subgroup 18.2 vs 8.3 mo, HR 0.48 (exploratory) | Approved HER2-low MBC (incl. HR-negative) ACTIVE – HER2-low indication; parallel pathway, not a TNBC-protocol trial |
Modi S et al. N Engl J Med 2022;387:9–20 (PMID 35665782) |
| — | Atezolizumab (Tecentriq) + paclitaxel IMpassion131 · NCT03125902 Roche/Genentech · N=651 · 1L |
Metastatic TNBC, previously untreated (confirmatory) vs Placebo + paclitaxel |
PD-L1 IC ≥1% (SP142) Confirmatory trial for SP142 IC≥1% population; did not confirm benefit. |
5.7 vs 5.6 mo, HR 0.82 (PD-L1+, NS) | 22.1 vs 28.3 mo (numerically favored placebo) | None – failed primary endpoint NEGATIVE – triggered withdrawal of atezolizumab TNBC indication |
Miles D et al. Ann Oncol 2021;32:994–1004 (PMID 34219000) |
| — | Pembrolizumab (Keytruda) monotherapy KEYNOTE-119 · NCT02555657 Merck (MSD) · N=622 · 2L/3L |
Metastatic TNBC, previously treated (1–2 prior lines) vs Chemo (physician's choice) |
PD-L1 CPS (stratified ≥10 / ≥1 / ITT) No mTNBC monotherapy indication resulted. |
Not met | No significant OS benefit (CPS≥10 HR 0.78, NS) | None – failed primary endpoint NEGATIVE – monotherapy not approved in mTNBC |
Winer EP et al. Lancet Oncol 2021;22:499–511 (PMID 33676601) |
| 2020-11-13 (accel); 2021-07-26 (full) | Pembrolizumab (Keytruda) + chemotherapy KEYNOTE-355 · NCT02819518 Merck (MSD) · N=847 (ITT) · 1L |
Locally recurrent unresectable/metastatic TNBC, previously untreated vs Placebo + chemo (nab-pac/pac/gem-carbo) |
PD-L1 CPS ≥10 Label: PD-L1 (CPS ≥10) "as determined by an FDA-authorized test". CDx: PD-L1 IHC 22C3 pharmDx (Agilent/Dako). |
9.7 vs 5.6 mo, HR 0.65 (CPS≥10) | 23.0 vs 16.1 mo, HR 0.73 (CPS≥10, P=0.0185) | Accelerated 2020-11-13; full 2021-07-26 (CPS≥10) ACTIVE – 1L standard for PD-L1 CPS≥10 |
Cortes J et al. Lancet 2020;396:1817–28 (PMID 33278935); Cortes J et al. N Engl J Med 2022;387:217–26 (PMID 35857659) |
| 2020-04-22 (accel); 2021-04-07 (full) | Sacituzumab govitecan (Trodelvy) ASCENT (confirmatory) · NCT02574455 Gilead (Immunomedics) · N=529 enrolled (468 without brain mets, primary analysis) · 2L+ |
Relapsed/refractory mTNBC, ≥2 prior therapies (≥1 for metastatic) vs Chemo (eribulin/vinorelbine/capecitabine/gemcitabine) |
None (Trop-2 ADC; not biomarker-selected) No companion diagnostic; approval not biomarker-restricted. |
5.6 vs 1.7 mo, HR 0.41 (P<0.001) | 12.1 vs 6.7 mo, HR 0.48 (P<0.001) | Accelerated 2020-04-22; full 2021-04-07 (2L+) ACTIVE – 2L+ indication (one of three SG mTNBC settings) |
Bardia A et al. N Engl J Med 2021;384:1529–41 (PMID 33882206) |
| 2019-03-08 | Atezolizumab (Tecentriq) + nab-paclitaxel IMpassion130 · NCT02425891 Roche/Genentech · N=902 · 1L |
Unresectable locally advanced/metastatic TNBC, previously untreated vs Placebo + nab-paclitaxel |
PD-L1 IC ≥1% (SP142) Original label: PD-L1 tumor-infiltrating immune cells (IC) ≥1%. CDx: VENTANA PD-L1 (SP142) Assay. (Indication withdrawn 2021.) |
7.5 vs 5.0 mo, HR 0.62 (PD-L1+) | 25.0 vs 18.0 mo, HR 0.62 (PD-L1+, not formally tested*) | Accelerated approval (PD-L1 IC≥1%) WITHDRAWN (voluntary 2021-08) after IMpassion131 failed confirmation |
Schmid P et al. N Engl J Med 2018;379:2108–21 (PMID 30345906); Adams S et al. Ann Oncol 2020;31:582–9 (PMID 32178964) |
| 2018-10-16 | Talazoparib (Talzenna) EMBRACA · NCT01945775 Pfizer · N=431 · Advanced (≤3 prior chemo) |
gBRCA1/2-mutated, HER2- locally advanced/metastatic breast cancer (~45% TNBC) vs Chemo (physician's choice) |
Germline BRCA1/2 mutation Label: "Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA." CDx: BRACAnalysis CDx (Myriad). |
8.6 vs 5.6 mo, HR 0.54 (P<0.001) | 19.3 vs 19.5 mo, HR 0.85 (NS) | Approved (gBRCAm HER2- MBC) ACTIVE – genotype indication (gBRCAm), not TNBC-restricted |
Litton JK et al. N Engl J Med 2018;379:753–63 (PMID 30110579) |
| 2018-01-12 | Olaparib (Lynparza) OlympiAD · NCT02000622 AstraZeneca · N=302 · Metastatic (≤2 prior chemo) |
gBRCA1/2-mutated, HER2- metastatic breast cancer (~50% TNBC) vs Chemo (capecitabine/vinorelbine/eribulin) |
Germline BRCA1/2 mutation Label: "Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza." CDx: BRACAnalysis CDx (Myriad). |
7.0 vs 4.2 mo, HR 0.58 (P<0.001) | 19.3 vs 19.6 mo, HR 0.90 (NS) | Approved (gBRCAm HER2- MBC) ACTIVE – genotype indication (gBRCAm), not TNBC-restricted |
Robson M et al. N Engl J Med 2017;377:523–33 (PMID 28578601) |