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New trial aims to beat cancer fatigue with common drug

NCT ID NCT07543536

Symptom relief Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests whether megestrol acetate, a drug often used for appetite loss, can prevent or reduce severe tiredness in 132 women with advanced breast cancer who are starting a treatment called trastuzumab deruxtecan (T-DXd). Participants will receive either megestrol acetate or a placebo, and researchers will track fatigue levels and quality of life over time. The goal is to help patients feel better during cancer therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced/metastatic breast cancer HER2+, low, or ultralow advanced/metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun yat-Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Sun yat-Sen University Cancer Center

    NOT_YET_RECRUITING

    Guangzhou, Yuexiu District, 510060, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.