Breast Cancer Patients Treated With T-DXdPhase 4NCT07254416
A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
A Phase 4 study testing NEPA, Dexamethasone and Megestrol Acetate in people with Breast Cancer Patients Treated With T-DXd, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This study was a multicenter, prospective, controlled trial involving 120 breast cancer patients receiving T-DXd-based therapy. Participants were randomly assigned to either the experimental group (NEPA plus megestrol acetate) or the control group (NEPA plus dexamethasone), with 60 patients in each group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Patients Treated With T-DXd
- What is being tested?
- NEPA, Dexamethasone and Megestrol Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 30 Jun 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is at least 18 years of age;
- The patient has a histologically or cytologically confirmed diagnosis of breast cancer;
- The patient is receiving full-dose trastuzumab deruxtecan (T-DXd) monoclonal antibody therapy for the first time;
- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or lower;
- The patient voluntarily agrees to comply fully with the study protocol requirements and has provided written informed consent.
Who cannot join
- The patient is currently taking medications that may interfere with the assessment of nausea or vomiting, including but not limited to other 5-HT3 receptor antagonists, NK1 receptor antagonists, psychotropic agents, or opioid analgesics;
- The investigator determines that the patient's nausea or vomiting is highly likely attributable to anti-tumor treatments not involving antibody-drug conjugate (ADC) therapy;
- The patient is deemed unsuitable for glucocorticoid or progesterone use;
- The patient has a history of hypersensitivity to netupitant, palonosetron, or any excipient in the capsule formulation;
- The patient has significant gastrointestinal conditions affecting oral drug absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction;
- The patient has a severe psychiatric disorder or difficulties understanding the study procedures, completing questionnaires, or communicating effectively in Chinese;
- The investigator identifies any other condition that may compromise the conduct of the clinical study or the interpretation of its results.
About this study
Official title: To Evaluate the Efficacy and Safety of NEPA Combined With Megestrol Acetate Versus NEPA Combined With Dexamethasone in Preventing Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
This study was a multicenter, prospective, controlled trial involving 120 breast cancer patients receiving T-DXd-based therapy. Participants were randomly assigned to either the experimental group (NEPA plus megestrol acetate) or the control group (NEPA plus dexamethasone), with 60 patients in each group. The intervention was administered over two treatment cycles. During this period, the onset time, frequency, and severity of nausea and vomiting were recorded and subjected to statistical analysis.
The primary objective of this study was to evaluate the efficacy and safety of netupitant/palonosetron capsules (NEPA) combined with megestrol acetate compared to the standard triple antiemetic regimen (NEPA plus dexamethasone) in preventing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients undergoing T-DXd-containing regimens. The findings aim to generate clinical evidence to support optimal antiemetic management, minimize the risk of dose reduction or treatment discontinuation due to gastrointestinal adverse events, and ultimately improve patient quality of life.
- Being tested
- NEPA, Dexamethasone, Megestrol Acetate
- Keywords
- NEPA, Netupitant and Palonosetron Hydrochloride Capsules, megeprogesterone acetate, dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEPADrug
On the first day, oral administration of NEPA(netopitan 300mg+ palonosetron 0.50mg)
DexamethasoneDrug
On the first day, oral administration of dexamethasone 6mg; From the 2nd to the 4th day, take dexamethasone 3.75mg orally per day.
Megestrol AcetateDrug
From the 1st to the 10th day, take 160mg of Megestrol Acetate orally per day.
| Study group | Role | What they receive |
|---|---|---|
| NEPA+ Megestrol Acetate | Experimental | Not described Receives: Drug: NEPA; Drug: Megestrol Acetate |
| NEPA+ Dexamethasone | Active comparator | Not described Receives: Drug: NEPA; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment
Measured: 0-120 hours (0-5 days)
Secondary outcomes (7)
The CR rates of 0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours after the first and second cycles of T-Dxd treatment.
Measured: 0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours
The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment
Measured: 0-120 hours (0-5 days)
The CC rates of 0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours after the first and second cycles of T-Dxd treatment.
Measured: 0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours
The time and duration of the first significant nausea and vomiting.
Measured: From the administration of T-Dxd to 21 days
The proportion of patients undergoing salvage treatment.
Measured: From the administration of T-Dxd to 21 days
The incidence of ADC reduction due to adverse reactions
Measured: From the administration of T-Dxd to 21 days
Evaluation of the EORTC QLQ-C30 (version 3) Quality of Life Questionnaire.
Measured: From the administration of T-Dxd to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Patients Treated With T-DXdStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Provincial Cancer Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Shanxi Bethune Hospital, Tianjin Cancer Hospital Airport Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254416
- Sponsor's protocol ID
- AKZ-ADC-01
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of NEPA Combined With Megestrol Acetate Versus NEPA Combined With Dexamethasone in Preventing Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07254416
- Acronym / sponsor ID
- AKZ-ADC-01
- Keywords
- NEPA, Netupitant and Palonosetron Hydrochloride Capsules, megeprogesterone acetate, dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Shaanxi Provincial Cancer Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Shanxi Bethune Hospital, Tianjin Cancer Hospital Airport Hospital
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Nov 2025 (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 was a multicenter, prospective, controlled trial involving 120 breast cancer patients receiving T-DXd-based therapy. Participants were randomly assigned to either the experimental group (NEPA plus megestrol acetate) or the control group (NEPA plus dexamethasone), with 60 patients in each group. The intervention was administered over two treatment cycles. During this period, the onset time, frequency, and severity of nausea and vomiting were recorded and subjected to statistical analysis.
The primary objective of this study was to evaluate the efficacy and safety of netupitant/palonosetron capsules (NEPA) combined with megestrol acetate compared to the standard triple antiemetic regimen (NEPA plus dexamethasone) in preventing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients undergoing T-DXd-containing regimens. The findings aim to generate clinical evidence to support optimal antiemetic management, minimize the risk of dose reduction or treatment discontinuation due to gastrointestinal adverse events, and ultimately improve patient quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEPA+ Megestrol Acetate | Experimental | Drug: NEPA, Drug: Megestrol Acetate |
| NEPA+ Dexamethasone | Active comparator | Drug: NEPA, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is at least 18 years of age;
- The patient has a histologically or cytologically confirmed diagnosis of breast cancer;
- The patient is receiving full-dose trastuzumab deruxtecan (T-DXd) monoclonal antibody therapy for the first time;
- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or lower;
- The patient voluntarily agrees to comply fully with the study protocol requirements and has provided written informed consent.
Key exclusion criteria (7 listed)
- The patient is currently taking medications that may interfere with the assessment of nausea or vomiting, including but not limited to other 5-HT3 receptor antagonists, NK1 receptor antagonists, psychotropic agents, or opioid analgesics;
- The investigator determines that the patient's nausea or vomiting is highly likely attributable to anti-tumor treatments not involving antibody-drug conjugate (ADC) therapy;
- The patient is deemed unsuitable for glucocorticoid or progesterone use;
- The patient has a history of hypersensitivity to netupitant, palonosetron, or any excipient in the capsule formulation;
- The patient has significant gastrointestinal conditions affecting oral drug absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction;
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 |
|---|---|---|
| NEPAOn the first day, oral administration of NEPA(netopitan 300mg+ palonosetron 0.50mg) | Drug | NEPA+ Dexamethasone, NEPA+ Megestrol Acetate |
| DexamethasoneOn the first day, oral administration of dexamethasone 6mg; From the 2nd to the 4th day, take dexamethasone 3.75mg orally per day. | Drug | NEPA+ Dexamethasone |
| Megestrol AcetateFrom the 1st to the 10th day, take 160mg of Megestrol Acetate orally per day. | Drug | NEPA+ Megestrol Acetate |
Primary outcome
The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment
Time frame: 0-120 hours (0-5 days)
7 secondary outcomes
The CR rates of 0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours after the first and second cycles of T-Dxd treatment.
Time frame: 0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours
The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment
Time frame: 0-120 hours (0-5 days)
The CC rates of 0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours after the first and second cycles of T-Dxd treatment.
Time frame: 0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours
The time and duration of the first significant nausea and vomiting.
Time frame: From the administration of T-Dxd to 21 days
The proportion of patients undergoing salvage treatment.
Time frame: From the administration of T-Dxd to 21 days
The incidence of ADC reduction due to adverse reactions
Time frame: From the administration of T-Dxd to 21 days
Evaluation of the EORTC QLQ-C30 (version 3) Quality of Life Questionnaire.
Time frame: From the administration of T-Dxd to 21 days
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 28 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Patients Treated With T-DXd
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Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
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RecruitingPhase 4
Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.
Locally Advanced or Metastatic Breast Cancers
Not yet recruiting
GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer
Breast Cancer
Not yet recruitingPhase 2
A Phase II Study of Trastuzumab Deruxtecan (T-DXd) Plus Pyrotinib in HER2-Positive Advanced Breast Cancer After Progression on T-DXd
Breast Cancer
Active, not recruitingPhase 2
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NEPA, Dexamethasone and Megestrol Acetate in people with Breast Cancer Patients Treated With T-DXd, run by Tianjin Medical University Cancer Institute and Hospital.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment (time frame: 0-120 hours (0-5 days)). 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 28 Nov 2025.