Phase 3 Megestrol Acetate Trial for T-DXd-Related Fatigue in Advanced Breast Cancer
Summary
ClinicalTrials.gov registered a new Phase 3 interventional study (NCT07543536) on April 22, 2026, evaluating whether Megestrol Acetate administered at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can prevent or alleviate T-DXd-related fatigue in patients with advanced or metastatic HER2+, HER2-low, or HER2-ultralow breast cancer. The trial will compare Megestrol Acetate plus T-DXd against placebo plus T-DXd. The study is sponsored by an unnamed party and is classified as Phase 3.
“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.”
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What changed
This document registers a new Phase 3 clinical trial on ClinicalTrials.gov. The trial will enroll patients with advanced or metastatic breast cancer (HER2+, HER2-low, or HER2-ultralow) to evaluate whether Megestrol Acetate combined with Trastuzumab Deruxtecan (T-DXd) reduces T-DXd-related fatigue compared to T-DXd plus placebo. The study description and intervention details are now publicly accessible via ClinicalTrials.gov.
Healthcare providers and clinical investigators in oncology should be aware of this trial for patient referral and clinical trial matching purposes. The registration provides structured information about eligibility criteria, interventions, and trial design but does not create any compliance obligations. Sponsors and clinical research organizations may use this registration to identify potential competitors in the same indication and therapeutic space.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
Phase 3 NCT07543536 Kind: PHASE3 Apr 22, 2026
Abstract
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.
Conditions: Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer
Interventions: Megestrol Acetate + Trastuzumab Deruxtecan, Placebo + Trastuzumab Deruxtecan
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