Advanced/Metastatic Breast CancerPhase 3MEGA-TACT-BC3NCT07543536
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
A Phase 3 study testing Megestrol Acetate + Trastuzumab Deruxtecan in people with Advanced/Metastatic Breast Cancer and HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer
- What is being tested?
- Megestrol Acetate + Trastuzumab Deruxtecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesChina
- Study dates
- 8 Jun 2026to 1 Apr 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Any condition judged by investigator that may affect study conduct or outcome assessment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
- Not yet recruiting
Sun yat-Sen University Cancer Center
Guangzhou, Yuexiu District, 510060
About this study
Official title: 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
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.
Read the detailed description
Evaluate the efficacy and safety of Megestrol Acetate (MA) in improving fatigue in breast cancer patients after T-DXd treatment.
- Conditions
- Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer
- Being tested
- Megestrol Acetate + Trastuzumab Deruxtecan, Placebo + Trastuzumab Deruxtecan
- Keywords
- Megestrol Acetate, Megestrol Acetate + Trastuzumab Deruxtecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol Acetate + Trastuzumab DeruxtecanDrug
Megestrol Acetate 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg/kg IV infusion every 3 weeks
Placebo + Trastuzumab DeruxtecanDrug
Matched placebo 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg/kg IV infusion every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Megestrol Acetate + Trastuzumab Deruxtecan Receives: Drug: Megestrol Acetate + Trastuzumab Deruxtecan |
| Control Group | Placebo comparator | Placebo + Trastuzumab Deruxtecan Receives: Drug: Placebo + Trastuzumab Deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue Score (FACIT-Fatigue Scale)
Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale Version 4. Total score range: 0-52, with higher scores indicating less fatigue and better quality of life.
Measured: From baseline to end of 2nd cycle (approximately 6 weeks)
Secondary outcomes (4)
Change in Brief Fatigue Inventory (BFI) Score
The Brief Fatigue Inventory (BFI) is a self-reported instrument designed to assess the severity and impact of cancer-related fatigue. It consists of 9 items:
3 items assess fatigue severity at its "worst," "usual," and "current" states over the past 24 hours.
1）6 items assess the degree to which fatigue interferes with daily activities (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life).
2）Scoring Criteria: Each item is rated on a 0 to 10 numerical scale, where 0 represents "no fatigue" or "does not interfere" and 10 represents "as bad as you can imagine" or "completely interferes." The total score is calculated as the average of the 9 items (range: 0-10).
Mild fatigue: 1 to 3 Moderate fatigue: 4 to 6 Severe fatigue: 7 to 10 Higher scores indicate greater fatigue severity and functional impairment.
Measured: Time Frame：Baseline (Day 1 of Cycle 1), Day 7 of Cycle 1, Cycle 2 (Day 1), Day 8 of Cycle 2, and Cycle 3 (Day 1).（each cycle is 28 days）
Objective Response Rate (ORR)
Including Complete Response (CR) and Partial Response (PR) per RECIST 1.1 criteria
Measured: Assessed every 6 weeks up to 24 weeks
Patient Reported Outcomes (PRO)
EORTC QLQ-C30 is a 30-item questionnaire used to assess the quality of life of cancer patients. It includes:
5 Functional Scales: Physical, role, cognitive, emotional, and social functioning.
3 Symptom Scales: Fatigue, pain, and nausea/vomiting. A Global Health Status/Quality of Life (GHS/QoL) scale. 6 Single Items: Dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficultie
EORTC QLQ-BR45 is a 45-item breast cancer-specific module used to assess quality of life. It consists of functional scales (e.g., body image, sexual functioning, breast satisfaction) and symptom scales (e.g., systemic therapy side effects, upset by hair loss, arm/breast symptoms, and skin/mucosal reactions to targeted therapies).
Scores are linearly transformed to a range of 0 to 100. For functional scales, a higher score represents a higher level of functioning/better quality of life. For symptom scales, a higher score represents a greater symptom burden or more severe side effects
Measured: Baseline (Day 1 of Cycle 1), Day 7 of Cycle 1, Cycle 2 (Day 1), Day 8 of Cycle 2, and Cycle 3 (Day 1)（each cycle is 28 days）
Safety and Tolerability
- Incidence of Adverse Events (AEs) graded by CTCAE v5.0
Measured: From first dose up to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start8 Jun 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- T-DXd: 5.4 mg/kg, IV drip, q3w. MA/Placebo: 160 mg, PO, d1-5, q3w for 2 cycles
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-Jia Huang, Sun Yat-sen University
- Investigators
- Jiajia Huang, PhD / Doctorate, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543536
- Sponsor's protocol ID
- MEGA-TACT-BC3
- Acronym
- MEGA-TACT-BC3
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07543536
- Acronym / sponsor ID
- MEGA-TACT-BC3 / MEGA-TACT-BC3
- Conditions
- Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer
- Keywords
- Megestrol Acetate, Megestrol Acetate + Trastuzumab Deruxtecan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evaluate the efficacy and safety of Megestrol Acetate (MA) in improving fatigue in breast cancer patients after T-DXd treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- T-DXd: 5.4 mg/kg, IV drip, q3w. MA/Placebo: 160 mg, PO, d1-5, q3w for 2 cycles
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Megestrol Acetate + Trastuzumab DeruxtecanMegestrol Acetate + Trastuzumab Deruxtecan |
| Control Group | Placebo comparator | Drug: Placebo + Trastuzumab DeruxtecanPlacebo + Trastuzumab Deruxtecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megestrol Acetate + Trastuzumab DeruxtecanMegestrol Acetate 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg/kg IV infusion every 3 weeks | Drug | Experimental Group |
| Placebo + Trastuzumab DeruxtecanMatched placebo 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg/kg IV infusion every 3 weeks | Drug | Control Group |
Primary outcome
Change in Fatigue Score (FACIT-Fatigue Scale)
Time frame: From baseline to end of 2nd cycle (approximately 6 weeks)
Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale Version 4. Total score range: 0-52, with higher scores indicating less fatigue and better quality of life.
4 secondary outcomes
Change in Brief Fatigue Inventory (BFI) Score
Time frame: Time Frame：Baseline (Day 1 of Cycle 1), Day 7 of Cycle 1, Cycle 2 (Day 1), Day 8 of Cycle 2, and Cycle 3 (Day 1).（each cycle is 28 days）
Objective Response Rate (ORR)
Time frame: Assessed every 6 weeks up to 24 weeks
Patient Reported Outcomes (PRO)
Time frame: Baseline (Day 1 of Cycle 1), Day 7 of Cycle 1, Cycle 2 (Day 1), Day 8 of Cycle 2, and Cycle 3 (Day 1)（each cycle is 28 days）
Safety and Tolerability
Time frame: From first dose up to 30 days after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiajia Huang, PhD / Doctorate principal investigator
Sun Yat-Sen University Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Megestrol Acetate + Trastuzumab Deruxtecan in people with Advanced/Metastatic Breast Cancer and HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meiting Chen Doctor, PhD / Doctorate (02087341812, chenmt@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Score (FACIT-Fatigue Scale) (time frame: From baseline to end of 2nd cycle (approximately 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.