Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)

CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK4/6 inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved patient survival. In this study, 18F-FES PET/CT will be e

Trial Details

NCT ID
NCT05861830
Phase
PHASE3
Sponsor
Peking Union Medical College Hospital
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • The combination of Dalpiciclib with physician-selected endocrine therapy
  • Chemotherapy selected by the physician
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • The recent pathology results showed HR-positive and HER2-negative.
  • 18F-FES-PET/CT showed at least one ER-positive lesion.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2 points.
  • Expected survival time ≥ 3 months.

For full eligibility, visit ClinicalTrials.gov.

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