NCT07543536RecruitingPhase 3
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 8 Jun 2026
- Primary completion date
- 1 Apr 2029
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07543536
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 132
- From 8 Jun 2026 to the primary completion date, 1 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving other antitumor therapies
Other illness
- Severe underlying disease, comorbidities, active infection, or severe metabolic disorders
- History of allergy to megestrol acetate or other components of the formulation
- History of thromboembolism (use with caution)
- Any condition judged by investigator that may affect study conduct or outcome assessment
Age
- 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
Other
- Clinically significant severe fatigue at baseline (FACIT-F score \<30)
- Pregnant or lactating patients
- Poor compliance or unable to complete normal follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.