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

Sponsor
Sun Yat-sen University
Study ID
NCT07543536
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Megestrol Acetate + Trastuzumab Deruxtecan — DRUG
    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
  • Placebo + Trastuzumab Deruxtecan — DRUG
    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

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2029
Completion
Apr 1, 2031

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    Megestrol Acetate + Trastuzumab Deruxtecan
  • Placebo Comparator: Control Group
    Placebo + Trastuzumab Deruxtecan

Primary Outcome Measure

Change in Fatigue Score (FACIT-Fatigue Scale) [ Time Frame: From baseline to end of 2nd cycle (approximately 6 weeks) ]

Central Contacts