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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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)
Demographics
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04501523 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received neoadjuvant chemotherapy.
Does this trial require ESR1?
Yes, ESR1 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR wild-type is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
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