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OncoMatch/Clinical Trials/NCT04437160

Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

Is NCT04437160 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Epirubicin or Pirarubicin and Cyclophosphamide for triple negative breast cancer.

Phase 2RecruitingChinese Academy of Medical SciencesNCT04437160Data as of May 2026

Treatment: Epirubicin or Pirarubicin · CyclophosphamideThis study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) negative (ihc 0/1+ or ish non-amplified)

Required: ESR1 negative (< 10%)

Required: PR (PGR) negative (< 10%)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: platinum-based chemotherapy — neoadjuvant

Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.

Must have received: taxane — neoadjuvant

Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.

Cannot have received: anthracycline

Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).

Cannot have received: other cytotoxic chemotherapy

Exception: except platinum and taxanes

Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).

Cannot have received: platinum-based chemotherapy

Exception: alone

Previous neoadjuvant chemotherapy with platinum or taxanes alone.

Cannot have received: taxane

Exception: alone

Previous neoadjuvant chemotherapy with platinum or taxanes alone.

Cannot have received: adjuvant therapy

Patients have received other adjuvant therapy.

Lab requirements

Blood counts

Adequate hematologic function

Kidney function

Patients without severe kidney disease

Liver function

Patients without severe liver disease

Cardiac function

Patients without severe heart disease

Patients without severe heart, lung, liver and kidney disease. Adequate hematologic and end-organ function.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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