> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-of-hrs-8080-tablets-in-metastatic-or-local-advanced-be8c053d-1d75-45a7-91cd-75a36df37c0c > Record changed: 2026-10-13 # A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults NCT05189717 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) Participants 156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) Lead sponsor Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) Start date 2022-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Title and summary **Summary** The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Short title** A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Official title** A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Dates **Completion date** 2025-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **First posted** 2022-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Registry last updated** 2022-04-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Primary completion date** 2024-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Start date** 2022-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Size and sites **Participants** 156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Planned participants** 156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Lead sponsor** Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Identifiers **Registry ID** NCT05189717 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **ClinicalTrials.gov ID** NCT05189717 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Outcomes ### Primary outcomes 1. Maximum tolerated dose Timeframe: up to 28 days The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus 2. Recommended phase II dose Timeframe: up to 28 days The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus 3. Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) Timeframe: up to 30 days after the last dose Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ### Secondary outcomes 1. Cmax Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. 2. Tmax Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc. 3. AUC0-t Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. 4. Cmax,ss Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. 5. Tmax,ss Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. 6. Cmin,ss Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. 7. AUCss Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. 8. Rac Timeframe: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. 9. ORR Timeframe: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months Objective Response Rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer 10. BOR Timeframe: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months Best Overall Response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer 11. DoR Timeframe: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months Duration of response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer 12. DCR Timeframe: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months Disease control rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer 13. PFS Timeframe: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months Progression-free survival, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. ECOG performance status score: 0-1; 2. Histopathologically documented local advanced or metastatic breast cancer ; 3. Female of not childbearing potential must the related requirement; 4. During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation; 5. Adequate organ functions as defined; 6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study. ### Exclusion criteria 1. For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment; 2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ; 3. History of clinically significant cardiovascular or cerebrovascular diseases; 4. The subject has one of many factors affecting oral drugs; 5. Active infection or fever with unknown cause > 38.5 °C; 6. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 7. Known history of allergy to study drug ingredients. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Sites - Fifth Medical Center of People's Liberation Army of China General HospitalBeijing, China - Jilin Cancer HospitalChangchun, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05189717) ## Related records ### Drugs (1) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.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) ### Targets (1) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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