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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 (May 2026). This Phase 2/3 trial studies multiple treatments including capecitabine and capecitabine + camrelizumab + apatinib for breast cancer.

Phase 2/3RecruitingSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT04803539Data as of May 2026

Treatment: capecitabine · capecitabine + camrelizumab + apatinibCirculating 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.

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Extracted eligibility criteria

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)

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.

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