A Phase 3 interventional study of HRS-6209 + Letrozole and Dalpciclib/Palbociclib + Letrozole/Anastrozole in Breast Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 1,050 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 571 studies on the registry; 86 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.
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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:
Exclusion Criteria:
Drug: HRS-6209 + Letrozole
Drug: Dalpciclib/Palbociclib + Letrozole/Anastrozole
HRS-6209 + Letrozole
Dalpciclib/Palbociclib + Letrozole/Anastrozole
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.
Time frame: Up to approximately 4 years
Overall Survival (OS)
Time from the date of randomization to the date of death due to any cause.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: 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
Time frame: Duration of the study approximately up to 13 years.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Jiangsu HengRui Medicine Co., Ltd. →