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

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

Recruiting
18-75 years
Female
Phase 3

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Overview

This study is a multicenter, open-label, randomized controlled, Phase 3 clinical trial.

Eligibility

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.

Study details
    Locally Advanced Breast Cancer
    Metastatic Breast Cancer

NCT07024173

Shandong Suncadia Medicine Co., Ltd.

16 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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