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OncoMatch/Clinical Trials/NCT06167694

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer

Is NCT06167694 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies HRS-8080; Dalpiciclib Isethionate Tablets for unresectable or metastatic breast cancer.

Phase 1/2RecruitingShandong Suncadia Medicine Co., Ltd.NCT06167694Data as of May 2026

Treatment: HRS-8080; Dalpiciclib Isethionate TabletsThis is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: endocrine therapy — advanced/metastatic

Dose-exploration stage: advanced stage has received at least 1 line of endocrine therapy progression in the past

Cannot have received: nitrosourea

Received nitrosourea or mitomycin within 6 weeks before the first dose in this study

Cannot have received: mitomycin

Received nitrosourea or mitomycin within 6 weeks before the first dose in this study

Cannot have received: cytotoxic chemotherapy

cytotoxic drugs ... within 4 weeks before the first medication

Cannot have received: immunotherapy

immunotherapy ... within 4 weeks before the first medication

Cannot have received: targeted therapy

targeted therapy ... within 4 weeks before the first medication

Cannot have received: anti-tumor traditional Chinese medicine

anti-tumor traditional Chinese medicine ... within 4 weeks before the first medication

Cannot have received: other clinical investigational drugs

other clinical investigational drugs within 4 weeks before the first medication

Cannot have received: endocrine therapy

He received endocrine therapy ... within 2 weeks before the first dose

Cannot have received: palliative radiotherapy

He received ... palliative radiotherapy within 2 weeks before the first dose

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

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