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OncoMatch/Clinical Trials/NCT05628870

A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer

Is NCT05628870 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies HRS-1358 for breast cancer.

Phase 1RecruitingShandong Suncadia Medicine Co., Ltd.NCT05628870Data as of May 2026

Treatment: HRS-1358The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: endocrine therapy — metastatic or advanced

Cannot have received: similar drugs

Lab requirements

Blood counts

Kidney function

Liver function

Adequate organ functions as defined

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

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