Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
Recruiting · NCT07543536 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
Megestrol Acetate + Trastuzumab DeruxtecanPlacebo + Trastuzumab Deruxtecan
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Sun yat-Sen University Cancer Center - Guangzhou, Guangdong, China
- Sun yat-Sen University Cancer Center - Guangzhou, Yuexiu District, China