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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Megestrol Acetate + Trastuzumab Deruxtecan |
|
| Control Group | Placebo Comparator | Placebo + Trastuzumab Deruxtecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to end of 2nd cycle (approximately 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meiting Chen Doctor, PhD / Doctorate | Contact | 02087341812 | chenmt@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiajia Huang, PhD / Doctorate | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-Sen University Cancer Center | Guangzhou | Yuexiu District | 510060 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| C000614160 | trastuzumab deruxtecan |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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T-DXd: 5.4 mg/kg, IV drip, q3w. MA/Placebo: 160 mg, PO, d1-5, q3w for 2 cycles
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| 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 |
|
| 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 | 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 | 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 | From first dose up to 30 days after last dose |
| D017437 |
| Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |