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

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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07024173

Enrollment

240

Registered

2025-06-17

Start date

2025-07-23

Completion date

2027-12-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Breast Cancer, Metastatic Breast Cancer

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.

Interventions

DRUGHRS-8080 Tablet

HRS-8080 tablet orally administered.

DRUGFulvestrant injection

Fulvestrant injection.

DRUGExemestane tablets

Exemestane tablets orally administered.

DRUGEverolimus Tablets

Everolimus tablets orally administered.

DRUGAnastrozole Tablets

Anastrozole tablets orally administered.

DRUGLetrozole Tablets

Letrozole tablets orally administered.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS) evaluated by the blinded independent central review (BICR).	Approximately 2 years.

Secondary

Measure	Time frame
Progression free survival (PFS) evaluated by investigators.	Approximately 2 years.
Overall response rate (ORR).	Approximately 2 years.
Clinical benefit rate (CBR).	Approximately 2 years.
Duration of response (DOR).	Approximately 2 years.
Overall survival (OS).	Approximately 3 years.
Adverse events (AEs).	Approximately 2 years.
Serious adverse events (SAEs).	Approximately 2 years.

Countries

China

Contacts

CONTACTMin Li

min.li.ml150@hengrui.com+86-0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026