A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer
NCT ID: NCT06974929
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2025-05-22
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HRS-6209 in Combination with Letrozole Group
HRS-6209 Capsules
Oral HRS-6209 capsules.
Letrozole Tablets
Oral Letrozole tablets.
HRS-6209 combined with Letrozole and HRS-2189 Group
HRS-6209 Capsules
Oral HRS-6209 capsules.
Letrozole Tablets
Oral Letrozole tablets.
HRS-2189 Tablets
HRS-2189 tablets.
Interventions
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HRS-6209 Capsules
Oral HRS-6209 capsules.
Letrozole Tablets
Oral Letrozole tablets.
HRS-2189 Tablets
HRS-2189 tablets.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jihui Hao
Role: primary
Other Identifiers
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HRS-6209-203
Identifier Type: -
Identifier Source: org_study_id