Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment

This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).

Trial Details

NCT ID
NCT07467330
Phase
PHASE3
Sponsor
Fujian Cancer Hospital
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • dalpiciclib + capecitabine + endocrine therapy
  • dalpiciclib + endocrine therapy
Locations (sample)
  • Fuzhou, Fujian, China|26.06139,119.30611

Key Eligibility Criteria

  • postmenopausal or premenopausal/perimenopausal women ≥ 18 years of age who meet one of the following: a) prior bilateral oophorectomy, or ≥ 60 year…
  • Female breast cancer patients diagnosed as HR positive and HER2 negative by pathological examination are not suitable for surgical resection or rad…
  • A) ER-positive and/or PR-positive are defined as having positively stained tumor cells representing ≥ 1% of all tumor cells (reviewed and confirmed…
  • ECOG score 0-2.

For full eligibility, visit ClinicalTrials.gov.

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