Breast CancerPhase 1/2NCT06974929
A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer
A Phase 1/2 study testing HRS-6209 Capsules, Letrozole Tablets and HRS-2189 Tablets in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HRS-6209 Capsules, Letrozole Tablets and HRS-2189 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2025to Dec 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, +86-022-23340123, haojihui@tjmuch.com
Jihui Hao
About this study
Official title: 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 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.
- Conditions
- Breast Cancer
- Being tested
- HRS-6209 Capsules, Letrozole Tablets, HRS-2189 Tablets
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6209 CapsulesDrug
Oral HRS-6209 capsules.
Letrozole TabletsDrug
Oral Letrozole tablets.
HRS-2189 TabletsDrug
HRS-2189 tablets.
| Study group | Role | What they receive |
|---|---|---|
| HRS-6209 in Combination with Letrozole Group | Experimental | Not described Receives: Drug: HRS-6209 Capsules; Drug: Letrozole Tablets |
| HRS-6209 combined with Letrozole and HRS-2189 Group | Experimental | Not described Receives: Drug: HRS-6209 Capsules; Drug: Letrozole Tablets; Drug: HRS-2189 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: 28 days after the first dose.
Maximum tolerated dose (MTD)
Measured: 28 days after the first dose.
Recommended phase II dose (RP2D)
Measured: 28 days after the first dose.
Adverse events (AEs)
Measured: About 1 year.
Serious adverse events (SAEs)
Measured: About 1 year.
Objective response rate (ORR)
Measured: About 1 year.
Secondary outcomes (4)
Best overall response (BOR)
Measured: About 1 year.
Duration of response (DoR)
Measured: About 1 year.
Clinical benefit rate (CBR)
Measured: About 1 year.
Progression-free survival (PFS)
Measured: About 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start22 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974929
- Sponsor's protocol ID
- HRS-6209-203
- Status last verified
- Jun 2026
- First submitted
- 8 May 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided