Condition: Breast Diseases · Breast Neoplasms · Dalpiciclib · Sponsor: Fujian Cancer Hospital
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III). Cohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.
This description comes directly from the study's public registry record.
Chuangui Song, doctor · 13960709993 · songcg1971@outlook.com
Always discuss trial participation with your own doctor first.
| Fujian Cancer Hosptial | Fuzhou, Fujian, China | Recruiting |
| West China Hospital of Sichuan University | Chengdu, Sichuan, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07581834