Changeflow GovPing Healthcare & Life Sciences Phase 3 Megestrol Acetate Trial for T-DXd-Relat...
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Phase 3 Megestrol Acetate Trial for T-DXd-Related Fatigue in Advanced Breast Cancer

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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.”

NIH , verbatim from source
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About this source

GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 676 changes logged to date.

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, 2026

GovPing 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.

← ClinicalTrials.gov Studies

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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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Clinical investigators Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Drug intervention study Oncology research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Public Health

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