What changed: Triple-negative breast cancer (TNBC)

When this page itself was last checked or edited.

First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible (TROPION-Breast02)

Adjuvant RCC with belzutifan; with sacituzumab govitecan in first-line PD-L1+ TNBC

First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04)

Positive interim phase 3 in pretreated TNBC (BL-B01D1-307) announced; regulatory submissions follow

First-line unresectable/metastatic TNBC, PD-1/PD-L1 inhibitor ineligible

Platinum-resistant PD-L1+ ovarian cancer; adjuvant RCC with belzutifan; with sacituzumab govitecan in 1L TNBC

First-line metastatic TNBC: monotherapy (PD-1 ineligible) or with pembrolizumab (PD-L1 CPS ≥10)

PFS and OS significantly improved at interim analysis (numbers presented ASCO 2026).

Iza-bren phase 3 positive (Feb 2026); FDA approves Dato-DXd and sacituzumab govitecan first line (Q2 2026).

PFS HR 0.

PFS HR 0.

OS 23.

ASCENT-03, ASCENT-04, and TROPION-Breast02 all positive; TROPION-Breast02 shows OS benefit.

NMPA approval, pretreated advanced TNBC (OptiTROP-Breast01); first TROP2 ADC approved in China

Pretreated advanced TNBC; later EGFR-mutant NSCLC after TKI

Ongoing; the first block results and de-escalation rates were reported from 2024.

Cancer detection 6.

5-year DFS 86.

OS HR 0.

DESTINY-Breast04 includes TNBC patients with HER2-low tumours.

EMA approval, pretreated metastatic TNBC

TNBC indication withdrawn after IMpassion131

High-risk early TNBC, neoadjuvant and adjuvant (KEYNOTE-522)

Full approval in metastatic TNBC (ASCENT); accelerated approval in urothelial cancer

High-risk early TNBC, neoadjuvant + adjuvant (KEYNOTE-522)

mTNBC ≥2 lines; HR+ 2023

iDFS HR 0.

Neoadjuvant/adjuvant pembrolizumab approved for stage II-III TNBC; OS benefit confirmed 2024.

One year of olaparib after standard therapy improves iDFS and OS in gBRCA carriers.

Metastatic TNBC, PD-L1 CPS ≥10, with chemotherapy (KEYNOTE-355)

Accelerated approval, metastatic TNBC after ≥2 prior therapies

Triple-negative breast cancer, CPS ≥10 (pembrolizumab plus chemotherapy)

Metastatic TNBC, PD-L1 CPS ≥10, with chemotherapy

Metastatic TNBC, ≥2 prior lines (accelerated; full 2021)

OS 12.

5-year ipsilateral breast tumour relapse 1.

PFS HR 0.

OS HR 0.

EFS HR 0.

Circulating tumour DNA matched tissue genotyping with about 93 percent sensitivity; neratinib (HER2 mutations) and capivasertib plus fulvestrant (AKT1 mutations, receptor-positive) met their response thresholds; extended-dose fulvestrant for ESR1 mutations did not.

KEYNOTE-355 in CPS ≥10 disease.

ASCENT: OS 12.1 vs 6.7 months in pretreated disease; first ADC for TNBC.

PD-L1+ metastatic TNBC with nab-paclitaxel (accelerated; IMpassion130)

Companion diagnostic for atezolizumab in PD-L1 IC ≥1% triple-negative breast cancer

10-year ipsilateral breast tumour recurrence 4.

PFS HR 0.

IMpassion130: atezolizumab + nab-paclitaxel improves PFS in PD-L1+ metastatic TNBC (approval later withdrawn).

OlympiAD and EMBRACA lead to olaparib and talazoparib approvals.

5-year local relapse 0.

Breakthrough Therapy designation for pretreated metastatic TNBC

Multiple graduations (veliparib-carboplatin, neratinib, pembrolizumab, MK-2206, T-DM1 plus pertuzumab, durvalumab plus olaparib, cemiplimab plus fianlimab); pembrolizumab's graduation preceded its approval in early triple-negative breast cancer.

10-year overall survival 82.

10-year disease-free survival 82.

GeparSixto and CALGB 40603 show platinum increases pathologic complete response.

Pathological complete response and early MRI volume change predicted recurrence-free survival, most strongly in triple-negative, HER2-positive and MammaPrint high-risk tumours.

No overall benefit; node-positive 5-year DFS 65.

10-year local-regional relapse 4.

Breast cancer events 16.

Defined by absence of ER, PR, HER2; recognised as the subtype with the fewest treatment options, which set the research agenda that followed.

Perou and Sørlie's expression profiling separates basal-like from luminal breast cancers.

82b: 10-year locoregional recurrence 9% vs 32%; overall survival 54% vs 45%.