NCT07894328Not yet recruitingPhase 3
A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1050 (estimated)
- First submitted
- 14 Oct 2026
- Start date
- 20 Nov 2026
- Primary completion date
- 30 Jul 2031
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07894328
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1050
- From 20 Nov 2026 to the primary completion date, 30 Jul 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inflammatory breast cancer.
- Individuals with a known history of allergy to any component of this medication.
Other
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Uncontrolled or untreated brain metastasis.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.