A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-8080 Tablet, Fulvestrant injection, Exemestane tablets, Everolimus Tablets.
- Who it may be relevant to
- Registry conditions: Locally Advanced Breast Cancer, Metastatic Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy
Overview
This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.
Interventions
- Drug HRS-8080 Tablet
HRS-8080 tablet orally administered. - Drug Fulvestrant injection
Fulvestrant injection. - Drug Exemestane tablets
Exemestane tablets orally administered. - Drug Everolimus Tablets
Everolimus tablets orally administered. - Drug Anastrozole Tablets
Anastrozole tablets orally administered. - Drug Letrozole Tablets
Letrozole tablets orally administered.
Primary outcome measures
- Progression free survival (PFS) evaluated by the blinded independent central review (BICR). [Time frame: Approximately 2 years.]
Secondary outcome measures (7)
- Progression free survival (PFS) evaluated by investigators. [Time frame: Approximately 2 years.]
- Overall response rate (ORR). [Time frame: Approximately 2 years.]
- Clinical benefit rate (CBR). [Time frame: Approximately 2 years.]
- Duration of response (DOR). [Time frame: Approximately 2 years.]
- Overall survival (OS). [Time frame: Approximately 3 years.]
- Adverse events (AEs). [Time frame: Approximately 2 years.]
- Serious adverse events (SAEs). [Time frame: Approximately 2 years.]
Eligibility criteria
Inclusion criteria
- Women aged 18 to 75 years old (including both values).
- ECOG Physical Strength Status (PS) : 0 to 1 point.
- Patients with locally advanced or metastatic breast cancer confirmed by histology.
- Patients previously received 1-2 lines of endocrine therapy.
- Expected survival > 6 months.
- The functional level of the organs must meet the requirements.
- Subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.
Exclusion criteria
- Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.
- A history of severe clinical cardiovascular diseases.
- Patients with uncontrollable tumor-related pain as judged by investigators.
- Severe infection exists within 4 weeks before the first study administration.
- Patients with clinically significant endometrial abnormalities.
- Untreated active hepatitis.
- Patients known to be allergic to HRS-8080 components.
- Pregnant and lactating women, or those planning to become pregnant during the study period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Sun Yat-sen University Cancer Center — Guangzhou
- Hunan Cancer Hospital — Changsha
Identifiers
NCT: NCT07024173 · HRS-8080-303