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

NCT07543536 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jiajia Huang, PhD / Doctorate · Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2029-04-01
Completion
2031-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543536 on ClinicalTrials.gov