HRS-6209 added to other treatments for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional trial will enroll women with advanced breast cancer who have radiographic progression after prior systemic therapy. Participants receive HRS-6209 capsules in combination with other regimens (for example letrozole or HRS-2189) in staged cohorts to define safety, tolerability, and dosing. The study will collect pharmacokinetic data and record adverse events while measuring preliminary anti-tumor activity by RECIST v1.1 in patients with measurable extracranial lesions. Standard clinic visits, laboratory tests, and serial imaging will be used to monitor patients and determine outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Women aged 18-75 years.
2. ECOG performance status 0-1.
3. Menopausal status.
4. Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration.
5. At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria.
6. Expected survival \> 3 months.
7. Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.
8. Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visits and procedures, understand the study procedures, and have signed the informed consent form.

Exclusion Criteria:

1. Symptomatic visceral metastasis and other conditions, and the researcher judged that endocrine therapy was not suitable for use.
2. History of clinically serious cardiovascular disease.
3. The ECG examination was abnormal.
4. Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
5. The subjects were in acute infection or active tuberculosis and needed drug treatment.
6. The patients received surgery, chemotherapy, immunotherapy and macromolecular targeted therapy within 4 weeks before the first medication.
7. Pregnant and lactating women, or intending to become pregnant during the study.
8. There was a clear history of neurological or mental disorders and the subjects had a history of psychotropic drug abuse or drug abuse.
9. In the course of this study, it is expected to receive other anti-tumor treatments or drugs.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaoyu Zhu
• Email: Xiaoyu.zhu@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.