RecruitingPhase 3NCT07543536

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

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

Sponsor

Sun Yat-sen University

Enrollment

132 participants

Start Date

Jun 8, 2026

Study Type

INTERVENTIONAL

Conditions

Advanced/Metastatic Breast Cancer HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Megestrol Acetate + Trastuzumab Deruxtecan and a drug called Placebo + Trastuzumab Deruxtecan for people with advanced/metastatic breast cancer and her2+, low, or ultralow advanced/metastatic breast cancer. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMegestrol 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

DRUGPlacebo + 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