Breast CancerPhase 3NCT07894328
A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
A Phase 3 study testing HRS-6209 + Letrozole and Dalpciclib/Palbociclib + Letrozole/Anastrozole in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to investigate the efficacy and safety of HRS-6209 in combination with letrozole compared with dalpciclib or palbociclib in combination with aromatase inhibitor in patients with advanced or metastatic breast cancer who have not received prior systemic treatment for advanced or metastatic… 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 + Letrozole and Dalpciclib/Palbociclib + Letrozole/Anastrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2026to 30 Sep 2031
- Phase
- Phase 3
- 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
- Female aged ≥ 18 and ≤ 75 years.
- Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease. Locally advanced diseased is not amenable to surgical resection or radiation therapy with curative intent.
- Untreated with any systemic anticancer therapy for their locally advanced or metastatic disease. Patients received prior standard (neo)adjuvant endocrine therapy must meet the following criteria:
- Complete neoadjuvant or adjuvant endocrine therapy for at least 24 months without recurrence or metastasis during treatment and 12 months after completion of treatment
- CDK4/6 inhibitor therapy for at least 12 months, if used in the (neo)adjuvant phase, with no recurrence or metastasis during treatment or within 12 months after completion of treatment.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1
- Adequate organ function.
Who cannot join
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Inflammatory breast cancer.
- Uncontrolled or untreated brain metastasis.
- Individuals with a known history of allergy to any component of this medication.
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
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao
About this study
Official title: A Multi-Center, Open-Label, Randomized Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
The purpose of this study is to investigate the efficacy and safety of HRS-6209 in combination with letrozole compared with dalpciclib or palbociclib in combination with aromatase inhibitor in patients with advanced or metastatic breast cancer who have not received prior systemic treatment for advanced or metastatic disease.
Approximately half of the participants will receive HRS-6209 plus letrozole while the other half of participants will receive dalpciclib or palbociclib in combination with aromatase inhibitor.
The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
- Conditions
- Breast Cancer
- Being tested
- HRS-6209 + Letrozole, Dalpciclib/Palbociclib + Letrozole/Anastrozole
- 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 + LetrozoleDrug
HRS-6209 + Letrozole
Dalpciclib/Palbociclib + Letrozole/AnastrozoleDrug
Dalpciclib/Palbociclib + Letrozole/Anastrozole
| Study group | Role | What they receive |
|---|---|---|
| Arm A: HRS-6209 + Letrozole | Experimental | Not described Receives: Drug: HRS-6209 + Letrozole |
| Arm B: CDK4/6 inhibitors+ Aromatase Inhibitor | Active comparator | Not described Receives: Drug: Dalpciclib/Palbociclib + Letrozole/Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to approximately 4 years
Secondary outcomes (7)
Overall Survival (OS)
Time from the date of randomization to the date of death due to any cause.
Measured: Up to approximately 13 years
Progression Free Survival (PFS) by Investigator
Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first
Measured: Up to approximately 4 years
Second progression-free survival (PFS2)
Time from randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.
Measured: Up to approximately 5 years
Overall Response Rate (ORR)
The percentage of participants who had a complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1.
Measured: Up to approximately 4 years
Clinical Benefit Rate (CBR)
Percentage of participants who have a CR, PR, or stable disease maintained for ≥ 24 weeks after randomization (without subsequent anticancer treatment) per RECIST v1.1 .
Measured: Up to approximately 4 years
Duration of Response (DOR)
Time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first, as assessed by BICR per RECIST v1.1.
Measured: Up to approximately 4 years
Incidence of treatment emergent treatment related adverse events/serious adverse events
Incidence and severity of AEs/SAEs graded according to NCI CTCAE v6.0
Measured: Duration of the study approximately up to 13 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completion30 Jul 2031 (estimated)
- Study completion30 Sep 2031 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, Open-Label, Randomized Study
- Masking
- None (open label)
- Enrolment
- 1,050 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
- NCT07894328
- Sponsor's protocol ID
- HRS-6209-302
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Randomized Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07894328
- Acronym / sponsor ID
- HRS-6209-302
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 26 Oct 2026 (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.
The purpose of this study is to investigate the efficacy and safety of HRS-6209 in combination with letrozole compared with dalpciclib or palbociclib in combination with aromatase inhibitor in patients with advanced or metastatic breast cancer who have not received prior systemic treatment for advanced or metastatic disease.
Approximately half of the participants will receive HRS-6209 plus letrozole while the other half of participants will receive dalpciclib or palbociclib in combination with aromatase inhibitor.
The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, Open-Label, Randomized Study
| Arm | Type | Receives |
|---|---|---|
| Arm A: HRS-6209 + Letrozole | Experimental | Drug: HRS-6209 + Letrozole |
| Arm B: CDK4/6 inhibitors+ Aromatase Inhibitor | Active comparator | Drug: Dalpciclib/Palbociclib + Letrozole/Anastrozole |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female aged ≥ 18 and ≤ 75 years.
- Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.
- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease. Locally advanced diseased is not amenable to surgical resection or radiation therapy with curative intent.
- Untreated with any systemic anticancer therapy for their locally advanced or metastatic disease. Patients received prior standard (neo)adjuvant endocrine therapy must meet the following criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (4 listed)
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Inflammatory breast cancer.
- Uncontrolled or untreated brain metastasis.
- Individuals with a known history of allergy to any component of this medication.
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 + LetrozoleHRS-6209 + Letrozole | Drug | Arm A: HRS-6209 + Letrozole |
| Dalpciclib/Palbociclib + Letrozole/AnastrozoleDalpciclib/Palbociclib + Letrozole/Anastrozole | Drug | Arm B: CDK4/6 inhibitors+ Aromatase Inhibitor |
Primary outcome
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 4 years
Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first.
7 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 13 years
Progression Free Survival (PFS) by Investigator
Time frame: Up to approximately 4 years
Second progression-free survival (PFS2)
Time frame: Up to approximately 5 years
Overall Response Rate (ORR)
Time frame: Up to approximately 4 years
Clinical Benefit Rate (CBR)
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
Incidence of treatment emergent treatment related adverse events/serious adverse events
Time frame: Duration of the study approximately up to 13 years.
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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 3 study testing HRS-6209 + Letrozole and Dalpciclib/Palbociclib + Letrozole/Anastrozole 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 9 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Oct 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiaonan Sheng (13524857678, xiaonan.sheng.xs6@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) (time frame: Up to approximately 4 years). 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 26 Oct 2026.