HRS-6209 added to other treatments for breast cancer

An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 Combination Therapy in Patients With Breast Cancer

This study will see if adding HRS-6209 to other breast cancer treatments is safe and can help control tumors in adults whose cancer has progressed.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06974929 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18–75 with ECOG 0–1, documented radiographic progression after prior systemic therapy, at least one measurable extracranial lesion per RECIST v1.1, expected survival >3 months, and who are not pregnant or breastfeeding are ideal candidates.

Not a fit: Patients with symptomatic visceral metastases or other significant medical conditions judged by investigators to increase risk are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that improves disease control for some patients with progressed breast cancer.

How similar studies have performed: Other early-phase combination studies in breast cancer have sometimes shown preliminary activity, but combinations involving HRS-6209 are novel and lack published large-scale results.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

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

Study contacts

• Study coordinator: Xiaoyu Zhu

Conditions Breast Cancer