A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
NCT ID: NCT07024173
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2025-07-23
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HRS-8080 Group
HRS-8080 Tablet
HRS-8080 tablet orally administered.
Fulvestrant Group
Fulvestrant injection
Fulvestrant injection.
Exemestane in combination with Everolimus Group
Exemestane tablets
Exemestane tablets orally administered.
Everolimus Tablets
Everolimus tablets orally administered.
Exemestane or Anastrozole or Letrozole Group
Exemestane tablets
Exemestane tablets orally administered.
Anastrozole Tablets
Anastrozole tablets orally administered.
Letrozole Tablets
Letrozole tablets orally administered.
Interventions
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HRS-8080 Tablet
HRS-8080 tablet orally administered.
Fulvestrant injection
Fulvestrant injection.
Exemestane tablets
Exemestane tablets orally administered.
Everolimus Tablets
Everolimus tablets orally administered.
Anastrozole Tablets
Anastrozole tablets orally administered.
Letrozole Tablets
Letrozole tablets orally administered.
Eligibility Criteria
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Inclusion Criteria
2. ECOG Physical Strength Status (PS) : 0 to 1 point.
3. Patients with locally advanced or metastatic breast cancer confirmed by histology.
4. Patients previously received 1-2 lines of endocrine therapy.
5. Expected survival \> 6 months.
6. The functional level of the organs must meet the requirements.
7. 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
2. A history of severe clinical cardiovascular diseases.
3. Patients with uncontrollable tumor-related pain as judged by investigators.
4. Severe infection exists within 4 weeks before the first study administration.
5. Patients with clinically significant endometrial abnormalities.
6. Untreated active hepatitis.
7. Patients known to be allergic to HRS-8080 components.
8. Pregnant and lactating women, or those planning to become pregnant during the study period.
18 Years
75 Years
FEMALE
No
Sponsors
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Shandong Suncadia Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Hunan Cancer Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HRS-8080-303
Identifier Type: -
Identifier Source: org_study_id
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