Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer (NCT07543536) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
China132 participantsStarted 2026-05-01
Plain-language summary
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 participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Fatigue Score (FACIT-Fatigue Scale)
Timeframe: From baseline to end of 2nd cycle (approximately 6 weeks)
. 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