A Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Trial Evaluating Megestrol Acetate for the Management of Fatigue in Advanced Breast Cancer Patients Treatment With Trastuzumab Deruxtecan
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 3
- 主要终点
- Change in Fatigue Score (FACIT-Fatigue Scale)
研究概览
简要总结
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.
详细描述
Evaluate the efficacy and safety of Megestrol Acetate (MA) in improving fatigue in breast cancer patients after T-DXd treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Adequate organ function
- •Reliable contraception or negative serum/urine pregnancy test within 7 days prior to enrollment; willing to use appropriate contraception during study and for 8 weeks after last dose
- •Voluntary participation with good compliance
排除标准
- •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
- •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
- •Any condition judged by investigator that may affect study conduct or outcome assessment
研究组 & 干预措施
Experimental Group
Megestrol Acetate + Trastuzumab Deruxtecan
干预措施: Megestrol Acetate + Trastuzumab Deruxtecan (Drug)
Control Group
Placebo + Trastuzumab Deruxtecan
干预措施: Placebo + Trastuzumab Deruxtecan (Drug)
结局指标
主要结局
Change in Fatigue Score (FACIT-Fatigue Scale)
时间窗: From baseline to end of 2nd cycle (approximately 6 weeks)
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.
次要结局
- Change in Brief Fatigue Inventory (BFI) Score(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)(Assessed every 6 weeks up to 24 weeks)
- Patient Reported Outcomes (PRO)(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(From first dose up to 30 days after last dose)
研究者
Jia-Jia Huang
Department of Medical Oncology Professor, Principal Investigator, Chief Physician
Sun Yat-sen University