OncoMatch/Clinical Trials/NCT04803539
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
Is NCT04803539 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including capecitabine and capecitabine + camrelizumab + apatinib for breast cancer.
Treatment: capecitabine · capecitabine + camrelizumab + apatinib — Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 wild-type (ER <=1%)
TNBC is defined as ER <=1%
Required: PR (PGR) wild-type (PR <=1%)
TNBC is defined as ... PR <=1%
Required: HER2 (ERBB2) wild-type (IHC=1, or IHC=2 and FISH negative)
HER2 receptor IHC=1, or IHC=2 and FISH negative
Disease stage
Required: Stage II, III
Excluded: Stage IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: adjuvant chemotherapy — adjuvant
Patient receives adjuvant chemotherapy according to the NCCN guidelines
Cannot have received: anti-PD-1/PD-L1 therapy
Patient has previously received any PD1/PDL1 blockage treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04803539 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1 therapy disqualifies patients from enrollment.
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.
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