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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 (Jun 2026). This Phase 1 trial studies HRS-1358 for breast cancer.

Phase 1RecruitingShandong Suncadia Medicine Co., Ltd.NCT05628870Data as of Jun 2026Location: China

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

Treatments studied

Other

HRS-1358

Cancer type

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75
Female only

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.

Frequently asked questions

Is NCT05628870 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior similar drugs disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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