NCT06974929 A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer
| NCT ID | NCT06974929 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-05-22 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06974929 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06974929 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06974929 currently recruiting?
Yes, NCT06974929 is actively recruiting participants. Contact the research team at Xiaoyu.zhu@hengrui.com for enrollment information.
Where is the NCT06974929 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06974929 clinical trial?
NCT06974929 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 80 participants.
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