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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Min Li
min.li.ml150@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2027-12
Participants
Target number of participants: 240
Treatments
Experimental: HRS-8080 Group
Active_comparator: Fulvestrant Group
Active_comparator: Exemestane in combination with Everolimus Group
Active_comparator: Exemestane or Anastrozole or Letrozole Group
Related Therapeutic Areas
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov