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OncoMatch/Clinical Trials/NCT07024173

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

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

Is NCT07024173 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments for locally advanced breast cancer.

Phase 3RecruitingShandong Suncadia Medicine Co., Ltd.NCT07024173Data as of Oct 2026Location: China

Treatment: HRS-8080 Tablet · Fulvestrant · Exemestane tablets · Everolimus Tablets · Anastrozole Tablets · Letrozole Tablets — 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.

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Extracted eligibility criteria

Treatments studied

Endocrine / hormonal

Fulvestrant

Other

HRS-8080 TabletExemestane tabletsEverolimus TabletsAnastrozole TabletsLetrozole Tablets

Cancer type

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75
Female only

Prior therapy

Must have received: endocrine therapy

Patients previously received 1-2 lines of endocrine therapy.

Cannot have received: systemic anti-tumor treatment (excluding chemotherapy, endocrine therapy, and CDK4/6 inhibitor); prior use of PI3K inhibitors or AKT inhibitors is permitted for patients with known PIK3CA mutations or PIK3CA/AKT/PTEN alterations

Exception: prior use of PI3K inhibitors or AKT inhibitors is permitted for patients with known PIK3CA mutations or PIK3CA/AKT/PTEN alterations

Patients previously received other systemic anti-tumor treatments besides chemotherapy、endocrine therapy and CDK4/6i (prior use of PI3K inhibitors or AKT inhibitors is permitted for patients with known PIK3CA mutations or PIK3CA/AKT/PTEN alterations).

Lab requirements

Blood counts

Kidney function

Liver function

The functional level of the organs must meet the requirements.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07024173 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic anti-tumor treatment (excluding chemotherapy, endocrine therapy, and CDK4/6 inhibitor); prior use of PI3K inhibitors or AKT inhibitors is permitted for patients with known PIK3CA mutations or PIK3CA/AKT/PTEN alterations disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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