Megestrol Acetate to Help Fatigue in T-DXd-Treated Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3 trial, participants with advanced or metastatic HER2-positive breast cancer who are about to begin Trastuzumab Deruxtecan (T-DXd) will be randomized to receive Megestrol Acetate or placebo in combination with T-DXd. The goal is to see if Megestrol Acetate can prevent or lessen fatigue and whether it is safe when used with T-DXd. Eligibility includes adults 18-75 with adequate organ function and ECOG 0-1. Outcomes will include fatigue levels and overall safety data. The study is conducted at Sun Yat-sen University Cancer Center in Guangzhou, China.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun yat-Sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Sun yat-Sen University Cancer Center
  Guangzhou, Yuexiu District, China Not yet recruiting

Study contacts

• Principal investigator: Jiajia Huang, PhD / Doctorate — Sun Yat-Sen University Cancer Center
• Study coordinator: Meiting Chen Doctor, PhD / Doctorate
• Email: chenmt@sysucc.org.cn
• Phone: 02087341812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.