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Study identifier: NCT07581834 Synced from ClinicalTrials.gov · July 29, 2026
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Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study

Condition: Breast Diseases · Breast Neoplasms · Dalpiciclib  ·  Sponsor: Fujian Cancer Hospital

PhasePhase 2
Planned participants2000
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

Talk to the study team

Chuangui Song, doctor  ·  13960709993  ·  songcg1971@outlook.com

Always discuss trial participation with your own doctor first.

Locations (2)

Fujian Cancer HosptialFuzhou, Fujian, ChinaRecruiting
West China Hospital of Sichuan UniversityChengdu, Sichuan, ChinaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07581834