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NCT07024173 | RECRUITING | Locally Advanced Breast Cancer

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
Sponsor:

Shandong Suncadia Medicine Co., Ltd.

Brief Summary:

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.

Condition or disease

Locally Advanced Breast Cancer

Metastatic Breast Cancer

Intervention/treatment

HRS-8080 Tablet

Fulvestrant injection

Exemestane tablets

Everolimus Tablets

Anastrozole Tablets

Letrozole Tablets

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-07-23
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Women aged 18 to 75 years old (including both values).
  • 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
  • 1. Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.
  • 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.
A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

Location Details

NCT07024173

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Guangdong

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510000

RECRUITING

China, Hunan

Hunan Cancer Hospital

Changsha, Hunan, China, 410000