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NCT Number: NCT07024173

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

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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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRS-8080 Tablet

Drug

HRS-8080 tablet orally administered.

Fulvestrant injection

Drug

Fulvestrant injection.

Exemestane tablets

Drug

Exemestane tablets orally administered.

Everolimus Tablets

Drug

Everolimus tablets orally administered.

Anastrozole Tablets

Drug

Anastrozole tablets orally administered.

Letrozole tablets

Drug

Letrozole tablets orally administered.

Primary outcomes

  1. Progression free survival (PFS) evaluated by the blinded independent central review (BICR).

    Time frame: Approximately 2 years.

Secondary outcomes

  1. Progression free survival (PFS) evaluated by investigators.

    Time frame: Approximately 2 years.

  2. Overall response rate (ORR).

    Time frame: Approximately 2 years.

  3. Clinical benefit rate (CBR).

    Time frame: Approximately 2 years.

  4. Duration of response (DOR).

    Time frame: Approximately 2 years.

  5. Overall survival (OS).

    Time frame: Approximately 3 years.

  6. Adverse events (AEs).

    Time frame: Approximately 2 years.

  7. Serious adverse events (SAEs).

    Time frame: Approximately 2 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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