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OncoMatch/Clinical Trials/NCT07354022

A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.

Is NCT07354022 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including HRS-8080 Tablet ; Dalpiciclib Isethionate and Fulvestrant for locally advanced or metastatic breast cancer.

Phase 3RecruitingShandong Suncadia Medicine Co., Ltd.NCT07354022Data as of May 2026

Treatment: HRS-8080 Tablet ; Dalpiciclib Isethionate · FulvestrantThe study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Metastatic disease required

locally advanced or metastatic breast cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: adjuvant endocrine therapy — adjuvant

Patients with prior adjuvant endocrine resistance following curative-intent surgery

Cannot have received: fulvestrant or other novel SERMs (fulvestrant)

Exception: excluding tamoxifen and toremifene

Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene)

Lab requirements

Blood counts

Kidney function

Liver function

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

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