A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
Recruiting · NCT07024173 · Interventional (participants receive a specific treatment) · Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Anastrozole TabletsEverolimus TabletsExemestane tabletsFulvestrant injectionHRS-8080 TabletLetrozole Tablets
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed.
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China
- Hunan Cancer Hospital - Changsha, Hunan, China