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Compares treatment options for Locally Advanced Breast Cancer
Official title A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07024173
What this study is testing
What is HRS-8080 Tablet?
HRS-8080 Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for locally advanced breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.