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Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
Sponsor: Sun Yat-sen University
Summary
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.
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Trial Evaluating Megestrol Acetate for the Management of Fatigue in Advanced Breast Cancer Patients Treatment With Trastuzumab Deruxtecan
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2026-05-01
Completion Date
2031-04-01
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
Megestrol Acetate + Trastuzumab Deruxtecan
Megestrol Acetate 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg/kg IV infusion every 3 weeks
Placebo + Trastuzumab Deruxtecan
Matched placebo 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg/kg IV infusion every 3 weeks
Locations (1)
Sun yat-Sen University Cancer Center
Guangzhou, Yuexiu District, China