Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer (NCT07543536) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
China132 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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
✓. No prior treatment with Trastuzumab Deruxtecan
✓. Received ≤5 lines (including 5 lines) of prior chemotherapy
✓. ECOG Performance Status 0-1
✓. Estimated life expectancy ≥12 weeks
Exclusion criteria
✕. 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
✕. Poor compliance or unable to complete normal follow-up
✕
What they're measuring
1
Change in Fatigue Score (FACIT-Fatigue Scale)
Timeframe: From baseline to end of 2nd cycle (approximately 6 weeks)
. History of allergy to megestrol acetate or other components of the formulation
✕. History of thromboembolism (use with caution)
✕. Other malignancies diagnosed within 5 years, except: resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally radically treated prostate cancer, surgically radically treated ductal carcinoma in situ, or malignancies diagnosed \>2 years ago with no current disease evidence and untreated for ≤2 years before randomization