Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Megestrol Acetate + Trastuzumab Deruxtecan, Placebo + Trastuzumab Deruxtecan.
- Who it may be relevant to
- Registry conditions: Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Evaluate the efficacy and safety of Megestrol Acetate (MA) in improving fatigue in breast cancer patients after T-DXd treatment.
Interventions
- Drug Megestrol Acetate + 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 - Drug Placebo + Trastuzumab Deruxtecan
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
Primary outcome measures
- Change in Fatigue Score (FACIT-Fatigue Scale) [Time frame: From baseline to end of 2nd cycle (approximately 6 weeks)]
Secondary outcome measures (4)
- Change in Brief Fatigue Inventory (BFI) Score [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) [Time frame: Assessed every 6 weeks up to 24 weeks]
- Patient Reported Outcomes (PRO) [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 [Time frame: From first dose up to 30 days after last dose]
Eligibility criteria
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
- 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
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun yat-Sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07543536 · MEGA-TACT-BC3