A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With 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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started May 2025
Shorter than P25 for phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 30, 2025
December 1, 2025
6 months
May 8, 2025
December 23, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Dose-limiting toxicity (DLT)
28 days after the first dose.
Maximum tolerated dose (MTD)
28 days after the first dose.
Recommended phase II dose (RP2D)
28 days after the first dose.
Adverse events (AEs)
About 1 year.
Serious adverse events (SAEs)
About 1 year.
Objective response rate (ORR)
About 1 year.
Secondary Outcomes (4)
Best overall response (BOR)
About 1 year.
Duration of response (DoR)
About 1 year.
Clinical benefit rate (CBR)
About 1 year.
Progression-free survival (PFS)
About 1 year.
Study Arms (2)
HRS-6209 in Combination with Letrozole Group
EXPERIMENTALHRS-6209 combined with Letrozole and HRS-2189 Group
EXPERIMENTALInterventions
Oral HRS-6209 capsules.
Oral Letrozole tablets.
Eligibility Criteria
You may qualify if:
- Women aged 18-75 years.
- ECOG performance status 0-1.
- Menopausal status.
- Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration.
- At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria.
- Expected survival \> 3 months.
- 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.
- 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.
You may not qualify if:
- Symptomatic visceral metastasis and other conditions, and the researcher judged that endocrine therapy was not suitable for use.
- History of clinically serious cardiovascular disease.
- The ECG examination was abnormal.
- Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
- The subjects were in acute infection or active tuberculosis and needed drug treatment.
- The patients received surgery, chemotherapy, immunotherapy and macromolecular targeted therapy within 4 weeks before the first medication.
- Pregnant and lactating women, or intending to become pregnant during the study.
- There was a clear history of neurological or mental disorders and the subjects had a history of psychotropic drug abuse or drug abuse.
- In the course of this study, it is expected to receive other anti-tumor treatments or drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2025
First Posted
May 16, 2025
Study Start
May 22, 2025
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
December 30, 2025
Record last verified: 2025-12