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Clinical Trials in China / NCT07354022
Recruiting Phase 3

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.

NCT07354022 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Phase
Phase 3
Started
2026-05-05
Last updated
2026-06-02

Condition(s) studied

Locally Advanced or Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

HRS-8080 Tablet ; Dalpiciclib IsethionateFulvestrant injection ;Dalpiciclib Isethionate

HRS-8080 Tablet ; Dalpiciclib Isethionate: * HRS-8080 Tablet * Dalpiciclib Isethionate

Fulvestrant injection ;Dalpiciclib Isethionate: * Fulvestrant injection * Dalpiciclib Isethionate

Study summary

The 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Women aged 18 - 75 years old; 2. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1; 3. Patients with histologically confirmed locally advanced or metastatic breast cancer; 4. Patients with prior adjuvant endocrine resistance following curative-intent surgery; 5. Menstrual status: postmenopausal, perimenopausal, or premenopausal; 6. Presence of evaluable lesions; 7. Organ function must meet required criteria. Exclusion Criteria: 1. Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy; 2. Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene); 3. Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression; 4. Patients with a history of clinically significant cardiovascular disease; 5. Participants who have not recovered from adverse effects caused by prior therapies; 6. Participants with a history of another malignancy within the past 5 years or currently having another malignancy; 7. Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General Hospital Fifth Medical Center Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07354022 on ClinicalTrials.gov ↗ ← All trials in China