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NOT YET RECRUITING
NCT07543536
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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