> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evluate-efficacy-and-safety-of-hrs-8080-combined-9ef76a92-dc01-4670-a800-b7bf49422ca3 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) Participants 912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) Lead sponsor Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) Start date 2026-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Short title** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Official title** A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Dates **Completion date** 2031-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **First posted** 2026-01-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Registry last updated** 2026-06-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Start date** 2026-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Size and sites **Participants** 912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Planned participants** 912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Lead sponsor** Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Identifiers **Registry ID** NCT07354022 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **ClinicalTrials.gov ID** NCT07354022 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Outcomes ### Primary outcomes 1. Investigator assessed Progression free survival (PFS) Timeframe: Up to 5 years. PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study. ### Secondary outcomes 1. Progression free survival (PFS) evaluated by the blinded independent central review (BICR) Timeframe: Up to 5 years 2. Overall response rate (ORR) Timeframe: Up to 5 years 3. Clinical benefit rate (CBR) Timeframe: Up to 5 years 4. Duration of response (DOR) Timeframe: Up to 5 years 5. Overall survival (OS) Timeframe: Up to 8 years 6. The incidence and severity of adverse events (AEs) Timeframe: Up to 5 years 7. The incidence and severity of serious adverse events (SAEs) Timeframe: Up to 5 years 8. Number of participants with vital sign abnormalities over the course of the study. Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature Timeframe: Up to 5 years 9. Number of participants with clinical laboratory test abnormalities for haematology and biochemistry parameters over the course of the study Timeframe: Up to 5 years 10. Heart rate (beats per minute) measured by 12-lead electrocardiography. Timeframe: Up to 5 years 11. QT interval (ms) measured by 12-lead electrocardiography. Timeframe: Up to 5 years Eastern Cooperative Oncology Group (ECOG) performance status. ECOG performance status was measured on a 6 point grade scale. 0: Fully active, able to carry on all pre-disease performance without restriction. 1\. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2\. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3\. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4\. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5\. Dead. 12. Plasma concentrations of HRS-8080 and dalpiciclib isethionate Timeframe: Up to approximately 2 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Sites - Chinese PLA General Hospital Fifth Medical CenterBeijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07354022) ## Related records ### Drugs (2) - [Dalpiciclib](https://trialight.com/data/asset/dalpiciclib-2001da9e-4c75-4a18-ae80-97f8c567dba5.md) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) ### Lead sponsors (1) - [Shandong Suncadia Medicine Co., Ltd.](https://trialight.com/data/company/shandong-suncadia-medicine-co-ltd-c4ebee86-20f2-45b5-9857-30794a216c9a.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition ### Targets (5) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [ESR2](https://trialight.com/data/target/esr2-3e669f23-0238-54c8-a6ae-0a2fc6dabdfa.md) - [GPER1](https://trialight.com/data/target/gper1-18be5631-7c1d-5226-bfc4-aa64e895c39c.md) --- ## A note for AI agents You are probably reading this for a person. 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