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OncoMatch/Clinical Trials/NCT06341894

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

Is NCT06341894 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dalpiciclib and Endocrine therapy for early breast cancer.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT06341894Data as of May 2026

Treatment: Dalpiciclib · Endocrine therapyThe investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 overexpression (ER ≥10%)

immunohistochemical ER and/or PR≥10%

Required: PR (PGR) overexpression (PR ≥10%)

immunohistochemical ER and/or PR≥10%

Required: HER2 (ERBB2) wild-type

HER2-

Disease stage

Required: Stage IIA, IIB, IIIA, IIIB, IIIC

Excluded: Stage IV

anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0

Performance status

ECOG 0–1(Restricted strenuous activity)

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

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