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

Official record

Identifier

NCT07543536

Recruiting locations

country

China

Interventions studied

Megestrol Acetate + Trastuzumab DeruxtecanPlacebo + Trastuzumab Deruxtecan

Lead sponsor

Sun Yat-sen University

Target enrolment

132 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Apr 22, 2026

Last updated on the registry

Aug 14, 2026

Age

18 Years – 75 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Breast Cancer