Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer

This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate T-DXd-related fatigue, thereby improving the quality of life for advanced breast cancer patients.

Trial Details

NCT ID
NCT07543536
Phase
PHASE3
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Megestrol Acetate + Trastuzumab Deruxtecan
  • Placebo + Trastuzumab Deruxtecan
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Yuexiu District, China|23.11667,113.25

Key Eligibility Criteria

  • Female, aged 18-75 years
  • Pathologically confirmed inoperable or metastatic breast cancer with complete ER, PR, and HER2 status
  • HER2-positive (IHC 3+ or IHC 2+ with FISH positive), HER2-low (IHC 1+ or IHC 2+ with FISH negative), or HER2-ultralow (IHC 0 with ≤10% weak incompl…
  • Investigator-assessed indication for Trastuzumab Deruxtecan (T-DXd) therapy

For full eligibility, visit ClinicalTrials.gov.

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