New Breast Cancer Drug HRS-6209 Tested With Letrozole First-Line
Tests HRS-6209 with letrozole against standard drugs in advanced breast cancer.
Plain-language title generated from the registry record
Registry title: A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07894328, who can take part
Where in China
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Trial code
- NCT07894328
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Inflammatory breast cancer; Individuals with a known history of allergy to any component of this medication; In visceral crisis at risk of immediately life-threatening complications in the short term; Uncontrolled or untreated brain metastasis.