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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06974929
- Acronym / sponsor ID
- HRS-6209-203
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-6209 in Combination with Letrozole Group | Experimental | Drug: HRS-6209 Capsules, Drug: Letrozole Tablets |
| HRS-6209 combined with Letrozole and HRS-2189 Group | Experimental | Drug: HRS-6209 Capsules, Drug: Letrozole Tablets, Drug: HRS-2189 Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-6209 CapsulesOral HRS-6209 capsules. | Drug | HRS-6209 combined with Letrozole and HRS-2189 Group, HRS-6209 in Combination with Letrozole Group |
| Letrozole TabletsOral Letrozole tablets. | Drug | HRS-6209 combined with Letrozole and HRS-2189 Group, HRS-6209 in Combination with Letrozole Group |
| HRS-2189 TabletsHRS-2189 tablets. | Drug | HRS-6209 combined with Letrozole and HRS-2189 Group |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 28 days after the first dose.
Maximum tolerated dose (MTD)
Time frame: 28 days after the first dose.
Recommended phase II dose (RP2D)
Time frame: 28 days after the first dose.
Adverse events (AEs)
Time frame: About 1 year.
Serious adverse events (SAEs)
Time frame: About 1 year.
Objective response rate (ORR)
Time frame: About 1 year.
4 secondary outcomes
Best overall response (BOR)
Time frame: About 1 year.
Duration of response (DoR)
Time frame: About 1 year.
Clinical benefit rate (CBR)
Time frame: About 1 year.
Progression-free survival (PFS)
Time frame: About 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu (+86-0518-82342973, Xiaoyu.zhu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 28 days after the first dose.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.