Evaluate the efficacy and safety of Megestrol Acetate (MA) in improving fatigue in breast cancer patients after T-DXd treatment.
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Female, aged 18-75 years
2. Pathologically confirmed inoperable or metastatic breast cancer with complete ER, PR, and HER2 status
3. 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) \[most recent specimen used\]
4. Investigator-assessed indication for Trastuzumab Deruxtecan (T-DXd) therapy
5. No prior treatment with Trastuzumab Deruxtecan
6. Received ≤5 lines (including 5 lines) of prior chemotherapy
7. ECOG Performance Status 0-1
8. Estimated life expectancy ≥12 weeks
9. Adequate organ function
10. 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
11. Voluntary participation with good compliance
You may not be if
1. Severe underlying disease, comorbidities, active infection, or severe metabolic disorders
2. Clinically significant severe fatigue at baseline (FACIT-F score \<30)
3. Currently receiving other antitumor therapies
4. Pregnant or lactating patients
5. Poor compliance or unable to complete normal follow-up
6. History of allergy to megestrol acetate or other components of the formulation
7. History of thromboembolism (use with caution)
8. 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
9. Any condition judged by investigator that may affect study conduct or outcome assessment
Clareo Health | Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
