OncoMatch/Clinical Trials/NCT06081244
NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
Is NCT06081244 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Sacituzumab govitecan and Pembrolizumab for triple negative breast cancer.
Treatment: Sacituzumab govitecan · Pembrolizumab — TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative or low positive (≤10% positive cells in IHC) (≤10% positive cells in IHC)
ER + PR negative or low positive (≤10% positive cells in IHC)
Required: PR (PGR) negative or low positive (≤10% positive cells in IHC) (≤10% positive cells in IHC)
ER + PR negative or low positive (≤10% positive cells in IHC)
Required: HER2 (ERBB2) negative (IHC 0 - 1+ or IHC 2+ with FISH negative) (IHC 0 - 1+ or IHC 2+ with FISH negative)
HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative)
Disease stage
Required: Stage I, II
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Exception: for any non-oncological reason unless clarified with sponsor
Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor
Lab requirements
Blood counts
Leucocytes ≥3.5 10^9/L, Neutrophils > 1.5 10^9/L, Platelets ≥100 10^9/L, Haemoglobin ≥10 g/dL
Kidney function
Creatinine ≤1.5 × ULN OR clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
AP < 5.0 ULN, AST ≤2.5 x ULN, ALT ≤2.5 x ULN, Total bilirubin ≤1 x ULN
Cardiac function
LVEF within normal limits of each institution, measured by echocardiography and normal ECG (within 42 days prior to treatment)
Laboratory requirements: Leucocytes ≥3.5 10^9/L, Neutrophils > 1.5 10^9/L, Platelets ≥100 10^9/L, Haemoglobin ≥10 g/dL, AP < 5.0 ULN, AST ≤2.5 x ULN, ALT ≤2.5 x ULN, Total bilirubin ≤1 x ULN, Creatinine ≤1.5 × ULN OR clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN; LVEF within normal limits of each institution, measured by echocardiography and normal ECG (within 42 days prior to treatment)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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