OncoMatch/Clinical Trials/NCT04501523
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
Is NCT04501523 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab and capecitabine for triple-negative breast cancer.
Treatment: Tislelizumab · capecitabine — Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 wild-type (≤ 1% of cells stain weakly positive)
ER will be considered negative if ≤ 1% of cells stain weakly positive
Required: PR (PGR) wild-type (≤ 1% of cells stain weakly positive)
PR will be considered negative if ≤ 1% of cells stain weakly positive
Required: HER2 (ERBB2) wild-type (IHC 0 or 1+, or 2+ with FISH ratio < 2.0 or < 6 copies per cell)
HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cell
Disease stage
Required: Stage II, III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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