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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06081244 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 negative or low positive (≤10% positive cells in IHC) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative or low positive (≤10% positive cells in IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (IHC 0 - 1+ or IHC 2+ with FISH negative) is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify