A Phase 3 interventional study of Megestrol Acetate + Trastuzumab Deruxtecan and Placebo + Trastuzumab Deruxtecan in Advanced/Metastatic Breast Cancer and HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer, sponsored by Sun Yat-sen University. Recruiting at 2 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
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.
Evaluate the efficacy and safety of Megestrol Acetate (MA) in improving fatigue in breast cancer patients after T-DXd treatment.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 132 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
Megestrol Acetate + Trastuzumab Deruxtecan
Drug: Megestrol Acetate + Trastuzumab Deruxtecan
Placebo + Trastuzumab Deruxtecan
Drug: Placebo + 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
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
Change in Fatigue Score (FACIT-Fatigue Scale)
Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale Version 4. Total score range: 0-52, with higher scores indicating less fatigue and better quality of life.
Time frame: From baseline to end of 2nd cycle (approximately 6 weeks)
Change in Brief Fatigue Inventory (BFI) Score
The Brief Fatigue Inventory (BFI) is a self-reported instrument designed to assess the severity and impact of cancer-related fatigue. It consists of 9 items: 3 items assess fatigue severity at its "worst," "usual," and "current" states over the past 24 hours. 1）6 items assess the degree to which fatigue interferes with daily activities (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life). 2）Scoring Criteria: Each item is rated on a 0 to 10 numerical scale, where 0 represents "no fatigue" or "does not interfere" and 10 represents "as bad as you can imagine" or "completely interferes." The total score is calculated as the average of the 9 items (range: 0-10). Mild fatigue: 1 to 3 Moderate fatigue: 4 to 6 Severe fatigue: 7 to 10 Higher scores indicate greater fatigue severity and functional impairment.
Time frame: Time Frame：Baseline (Day 1 of Cycle 1), Day 7 of Cycle 1, Cycle 2 (Day 1), Day 8 of Cycle 2, and Cycle 3 (Day 1).（each cycle is 28 days）
Objective Response Rate (ORR)
Including Complete Response (CR) and Partial Response (PR) per RECIST 1.1 criteria
Time frame: Assessed every 6 weeks up to 24 weeks
Patient Reported Outcomes (PRO)
EORTC QLQ-C30 is a 30-item questionnaire used to assess the quality of life of cancer patients. It includes: 5 Functional Scales: Physical, role, cognitive, emotional, and social functioning. 3 Symptom Scales: Fatigue, pain, and nausea/vomiting. A Global Health Status/Quality of Life (GHS/QoL) scale. 6 Single Items: Dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficultie EORTC QLQ-BR45 is a 45-item breast cancer-specific module used to assess quality of life. It consists of functional scales (e.g., body image, sexual functioning, breast satisfaction) and symptom scales (e.g., systemic therapy side effects, upset by hair loss, arm/breast symptoms, and skin/mucosal reactions to targeted therapies). Scores are linearly transformed to a range of 0 to 100. For functional scales, a higher score represents a higher level of functioning/better quality of life. For symptom scales, a higher score represents a greater symptom burden or more severe side effects
Time frame: Baseline (Day 1 of Cycle 1), Day 7 of Cycle 1, Cycle 2 (Day 1), Day 8 of Cycle 2, and Cycle 3 (Day 1)（each cycle is 28 days）
Safety and Tolerability
1\. Incidence of Adverse Events (AEs) graded by CTCAE v5.0
Time frame: From first dose up to 30 days after last dose
Plan to share: Undecided
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