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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSun Yat-sen University

About this trial

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 criteria

Qualifiers

Female, aged 18-75 years

Pathologically confirmed inoperable or metastatic breast cancer with complete ER, PR, and HER2 status

HER2-positive (IHC 3+ or IHC 2+ with FISH positive), HER2-low (IHC 1+ or IHC 2+ with FISH negative), or HER2-ultralow (IHC 0 with ≤10% weak incomplete membrane staining) [most recent specimen used]

Investigator-assessed indication for Trastuzumab Deruxtecan (T-DXd) therapy

Disqualifiers

Severe underlying disease, comorbidities, active infection, or severe metabolic disorders

Clinically significant severe fatigue at baseline (FACIT-F score <30)

Currently receiving other antitumor therapies

Pregnant or lactating patients

Trial design

Treatments tested in this trial

  • Megestrol Acetate + Trastuzumab Deruxtecan
  • Placebo + Trastuzumab Deruxtecan

Treatment groups

132 Participants
are divided into 2 treatment groups

Sponsors and collaborators