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

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 3

Conditions: Locally Advanced Breast Cancer; Metastatic Breast Cancer

Treatments: Drug: Fulvestrant injection; Drug: Letrozole Tablets; Drug: HRS-8080 Tablet; Drug: Everolimus Tablets; Drug: Anastrozole Tablets; Drug: Exemestane tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024173

HRS-8080-303

Details and patient eligibility

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

HRS-8080 Group

Experimental group

Treatment:

Drug: HRS-8080 Tablet

Fulvestrant Group

Active Comparator group

Treatment:

Drug: Fulvestrant injection

Exemestane in combination with Everolimus Group

Active Comparator group

Treatment:

Drug: Exemestane tablets

Drug: Everolimus Tablets

Exemestane or Anastrozole or Letrozole Group

Active Comparator group

Treatment:

Drug: Exemestane tablets

Drug: Anastrozole Tablets

Drug: Letrozole Tablets