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Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer

RecruitingPhase 3

Sponsor: Sun Yat-sen University

Conditions: Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer

Interventions: Megestrol Acetate + Trastuzumab Deruxtecan, Placebo + Trastuzumab Deruxtecan

Countries: China

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Locations (2)

Guangzhou, Guangdong, China
Guangzhou, Yuexiu District, China