Trial · NCT07894328
A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
NCT07894328, Phase 3, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer. Trials, record NCT07894328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07894328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
- NCT number
- NCT07894328
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 1,050 participants, estimated
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Conditions
- Breast Cancer
- Interventions
- HRS-6209 + Letrozole, Dalpciclib/Palbociclib + Letrozole/Anastrozole
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) | 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. |
| Secondary | Overall Survival (OS) | Up to approximately 13 years | Time from the date of randomization to the date of death due to any cause. |
| Secondary | Progression Free Survival (PFS) by Investigator | 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 investigator per RECIST v1.1, or death due to any cause, whichever occurs first |
| Secondary | Second progression-free survival (PFS2) | Up to approximately 5 years | Time from randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death. |
| Secondary | Overall Response Rate (ORR) | Up to approximately 4 years | The percentage of participants who had a complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1. |
| Secondary | Clinical Benefit Rate (CBR) | Up to approximately 4 years | 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 . |
| Secondary | Duration of Response (DOR) | Up to approximately 4 years | 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. |
| Secondary | Incidence of treatment emergent treatment related adverse events/serious adverse events | Duration of the study approximately up to 13 years. | Incidence and severity of AEs/SAEs graded according to NCI CTCAE v6.0 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07894328
GET https://conductscience.org/api/trials/v1/NCT07894328/registered