Breast CancerPhase 2NCT07918079
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
A Phase 2 study testing Netupitant and Palonosetron, Dexamethasone and Olanzapine 5 Mg ORAL TABLET in people with Breast Cancer, run by Fudan University.
Trial summary
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Netupitant and Palonosetron, Dexamethasone and Olanzapine 5 Mg ORAL TABLET
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 1 Nov 2028
- Phase
- Phase 2
- 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
- Age ≥ 18 years. Histologically or cytologically confirmed breast cancer. Planned to initially receive one of the following antibody-drug conjugate (ADC) agents: trastuzumab deruxtecan (T-DXd), trastuzumab rezetecan (SHR-A1811), or datopotamab deruxtecan (Dato-DXd).
- Planned to use netupitant/palonosetron capsules (NEPA) prophylactically as an antiemetic prior to ADC therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Expected survival ≥ 3 months.
- Adequate organ function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases); Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min. Able to understand and voluntarily sign written informed consent. Able and willing to use an electronic patient-reported outcome (ePRO) device to complete daily diary records.
Who cannot join
- Currently participating in another clinical trial that may affect the antiemetic evaluation or drug exposure of this study.
- Nausea (Visual Analog Scale [VAS] ≥ 5 mm) or vomiting within 24 hours prior to enrollment.
- Use of any antiemetic medication within 2 weeks prior to enrollment, including 5-HT3 receptor antagonists, NK1 receptor antagonists, glucocorticoids, metoclopramide, olanzapine, etc.
- Use of benzodiazepines, opioids, or opioid-like medications within 1 week prior to enrollment or planned use during the study period (especially the Day 1-21 observation window), except single doses of midazolam, temazepam, or triazolam.
- Known allergy to netupitant, palonosetron, or excipients of the NEPA capsule. Symptomatic brain metastases or leptomeningeal metastases (patients who have received treatment and been stable for ≥ 4 weeks are eligible).
- Uncontrolled serious medical conditions, including but not limited to: uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), uncontrolled diabetes (HbA1c ≥ 8.0%), New York Heart Association (NYHA) functional classification ≥ III, myocardial infarction or unstable angina within 6 months, or history of clinically significant QT interval prolongation.
- Psychiatric disorder or cognitive impairment that may affect the reliability of nausea/vomiting assessment or ePRO completion.
- Pregnant or lactating women. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Netupitant/Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugate Therapy in Breast Cancer: A Randomized, Multicenter, Exploratory Phase II Study
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
- Conditions
- Breast Cancer
- Being tested
- Netupitant and Palonosetron, Dexamethasone, Olanzapine 5 Mg ORAL TABLET
- Keywords
- Nausea and Vomiting
- Medical subject headings
- Breast Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netupitant and PalonosetronDrug
Oral fixed-dose netupitant/palonosetron (NEPA) capsule (300 mg netupitant / 0.5 mg palonosetron), 1 capsule administered orally.
DexamethasoneDrug
Dexamethasone 12 mg administered orally or intravenously on Day 1, , followed by 8 mg orally or intravenously once daily on Days 2-4. No dexamethasone is administered on Day 5 or during Days 6-21.
Olanzapine 5 Mg ORAL TABLETDrug
Olanzapine 5 mg administered orally once daily on Days 1-4. No olanzapine is administered on Day 5 or during Days 6-21.
| Study group | Role | What they receive |
|---|---|---|
| Standard (No Extended NEPA) | Active comparator | Standard antiemetic regimen consisting of netupitant/palonosetron (NEPA), dexamethasone, and olanzapine administered on Days 1-4 (Day 5: observation only). No extended NEPA dosing is given from Day 6 through Day 21. Receives: Drug: Netupitant and Palonosetron; Drug: Dexamethasone; Drug: Olanzapine 5 Mg ORAL TABLET |
| Extended NEPA (3 Boosts) | Experimental | Standard antiemetic regimen (NEPA + dexamethasone + olanzapine) on Days 1-4, plus one additional NEPA capsule (netupitant 300 mg/palonosetron 0.5 mg, PO) on each of Days 6, 11, and 16. Receives: Drug: Netupitant and Palonosetron; Drug: Dexamethasone; Drug: Olanzapine 5 Mg ORAL TABLET |
| Extended NEPA (2 Boosts) | Experimental | Standard antiemetic regimen (NEPA + dexamethasone + olanzapine) on Days 1-4, plus one additional NEPA capsule (netupitant 300 mg/palonosetron 0.5 mg, PO) on each of Days 6 and 13. Receives: Drug: Netupitant and Palonosetron; Drug: Dexamethasone; Drug: Olanzapine 5 Mg ORAL TABLET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with No Nausea (VAS < 5 mm) During the 120-504 Hour Window After ADC Administration
The no-nausea rate, defined as the proportion of participants with a Visual Analog Scale (VAS) nausea score < 5 mm, assessed during the 120-504 hour window (Days 6-21) following ADC (trastuzumab deruxtecan, trastuzumab rezetecan [SHR-A1811], or datopotamab deruxtecan) administration.
Measured: 120 to 504 hours (Days 6-21) after ADC administration
Secondary outcomes (6)
Percentage of Participants with No Significant Nausea (VAS < 25 mm) During the 120-504 Hour Window
Proportion of participants with a VAS nausea score < 25 mm during the 120-504 hour window after ADC administration.
Measured: 120-504 hours (Days 6-21) after ADC administration
Percentage of Participants with No Vomiting During the 120-504 Hour Window
Proportion of participants who did not experience vomiting during the 120-504 hour window after ADC administration.
Measured: 120-504 hours (Days 6-21) after ADC administration
Complete Response (CR) Rate During the 120-504 Hour Window
Proportion of participants achieving complete response, defined as no vomiting and no use of rescue medication, during the 120-504 hour window. (Definitions per protocol.)
Measured: 120-504 hours (Days 6-21) after ADC administration
Complete Protection (CP) Rate During the 120-504 Hour Window
Proportion of participants achieving complete protection (no nausea [VAS < 5 mm], no vomiting, and no rescue medication) during the 120-504 hour window. (Definitions per protocol.)
Measured: 120-504 hours (Days 6-21) after ADC administration
Total Control (TC) Rate During the 120-504 Hour Window
Proportion of participants achieving total control (no nausea [VAS = 0], no vomiting, and no rescue medication) during the 120-504 hour window. (Definitions per protocol.)
Measured: 120-504 hours (Days 6-21) after ADC administration
Antiemetic Efficacy Across Time Windows: No Nausea, No Significant Nausea, No Vomiting, CR, CP, TC, and Rescue Medication Rates
For each of four time windows (0-24 h acute, 24-120 h delayed, 0-120 h overall, and 0-504 h full course [Day 1-21]), the following binary endpoints are assessed: no nausea rate (VAS < 5 mm), no significant nausea rate (VAS < 25 mm), no vomiting rate, complete response (CR) rate, complete protection (CP) rate, total control (TC) rate, and rescue medication use rate. The 0-120 h window reflects the period in which all three arms received identical baseline antiemetic prophylaxis (Days 1-5); by design no systematic between-arm difference is expected, and this window is used to verify the comparability of baseline efficacy and the internal consistency of the study. Missing-data handling is consistent with the primary endpoint.
Measured: Acute phase 0-24 h; delayed phase 24-120 h; overall 0-120 h; full course 0-504 h (Day 1-21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918079
- Sponsor's protocol ID
- 2610355-28
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Netupitant/Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugate Therapy in Breast Cancer: A Randomized, Multicenter, Exploratory Phase II Study
- ClinicalTrials.gov ID
- NCT07918079
- Acronym / sponsor ID
- 2610355-28
- Conditions
- Breast Cancer
- Keywords
- Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 5 Nov 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.
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard (No Extended NEPA) | Active comparator | Drug: Netupitant and Palonosetron, Drug: Dexamethasone, Drug: Olanzapine 5 Mg ORAL TABLETStandard antiemetic regimen consisting of netupitant/palonosetron (NEPA), dexamethasone, and olanzapine administered on Days 1-4 (Day 5: observation only). No extended NEPA dosing is given from Day 6 through Day 21. |
| Extended NEPA (3 Boosts) | Experimental | Drug: Netupitant and Palonosetron, Drug: Dexamethasone, Drug: Olanzapine 5 Mg ORAL TABLETStandard antiemetic regimen (NEPA + dexamethasone + olanzapine) on Days 1-4, plus one additional NEPA capsule (netupitant 300 mg/palonosetron 0.5 mg, PO) on each of Days 6, 11, and 16. |
| Extended NEPA (2 Boosts) | Experimental | Drug: Netupitant and Palonosetron, Drug: Dexamethasone, Drug: Olanzapine 5 Mg ORAL TABLETStandard antiemetic regimen (NEPA + dexamethasone + olanzapine) on Days 1-4, plus one additional NEPA capsule (netupitant 300 mg/palonosetron 0.5 mg, PO) on each of Days 6 and 13. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years. Histologically or cytologically confirmed breast cancer. Planned to initially receive one of the following antibody-drug conjugate (ADC) agents: trastuzumab deruxtecan (T-DXd), trastuzumab rezetecan (SHR-A1811), or datopotamab deruxtecan (Dato-DXd).
- Planned to use netupitant/palonosetron capsules (NEPA) prophylactically as an antiemetic prior to ADC therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Expected survival ≥ 3 months.
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases); Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min. Able to understand and voluntarily sign written informed consent. Able and willing to use an electronic patient-reported outcome (ePRO) device to complete daily diary records.
Key exclusion criteria (8 listed)
- Currently participating in another clinical trial that may affect the antiemetic evaluation or drug exposure of this study.
- Nausea (Visual Analog Scale [VAS] ≥ 5 mm) or vomiting within 24 hours prior to enrollment.
- Use of any antiemetic medication within 2 weeks prior to enrollment, including 5-HT3 receptor antagonists, NK1 receptor antagonists, glucocorticoids, metoclopramide, olanzapine, etc.
- Use of benzodiazepines, opioids, or opioid-like medications within 1 week prior to enrollment or planned use during the study period (especially the Day 1-21 observation window), except single doses of midazolam, temazepam, or triazolam.
- Known allergy to netupitant, palonosetron, or excipients of the NEPA capsule. Symptomatic brain metastases or leptomeningeal metastases (patients who have received treatment and been stable for ≥ 4 weeks are eligible).
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 |
|---|---|---|
| Netupitant and PalonosetronOral fixed-dose netupitant/palonosetron (NEPA) capsule (300 mg netupitant / 0.5 mg palonosetron), 1 capsule administered orally. | Drug | Extended NEPA (2 Boosts), Extended NEPA (3 Boosts), Standard (No Extended NEPA) |
| DexamethasoneDexamethasone 12 mg administered orally or intravenously on Day 1, , followed by 8 mg orally or intravenously once daily on Days 2-4. No dexamethasone is administered on Day 5 or during Days 6-21. | Drug | Extended NEPA (2 Boosts), Extended NEPA (3 Boosts), Standard (No Extended NEPA) |
| Olanzapine 5 Mg ORAL TABLETOlanzapine 5 mg administered orally once daily on Days 1-4. No olanzapine is administered on Day 5 or during Days 6-21. | Drug | Extended NEPA (2 Boosts), Extended NEPA (3 Boosts), Standard (No Extended NEPA) |
Primary outcome
Percentage of Participants with No Nausea (VAS < 5 mm) During the 120-504 Hour Window After ADC Administration
Time frame: 120 to 504 hours (Days 6-21) after ADC administration
The no-nausea rate, defined as the proportion of participants with a Visual Analog Scale (VAS) nausea score < 5 mm, assessed during the 120-504 hour window (Days 6-21) following ADC (trastuzumab deruxtecan, trastuzumab rezetecan [SHR-A1811], or datopotamab deruxtecan) administration.
6 secondary outcomes
Percentage of Participants with No Significant Nausea (VAS < 25 mm) During the 120-504 Hour Window
Time frame: 120-504 hours (Days 6-21) after ADC administration
Percentage of Participants with No Vomiting During the 120-504 Hour Window
Time frame: 120-504 hours (Days 6-21) after ADC administration
Complete Response (CR) Rate During the 120-504 Hour Window
Time frame: 120-504 hours (Days 6-21) after ADC administration
Complete Protection (CP) Rate During the 120-504 Hour Window
Time frame: 120-504 hours (Days 6-21) after ADC administration
Total Control (TC) Rate During the 120-504 Hour Window
Time frame: 120-504 hours (Days 6-21) after ADC administration
Antiemetic Efficacy Across Time Windows: No Nausea, No Significant Nausea, No Vomiting, CR, CP, TC, and Rescue Medication Rates
Time frame: Acute phase 0-24 h; delayed phase 24-120 h; overall 0-120 h; full course 0-504 h (Day 1-21)
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 5 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Netupitant and Palonosetron, Dexamethasone and Olanzapine 5 Mg ORAL TABLET in people with Breast Cancer, run by Fudan University.
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 8 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 5 Nov 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jian Zhang, MD, PhD (+8664175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with No Nausea (VAS < 5 mm) During the 120-504 Hour Window After ADC Administration (time frame: 120 to 504 hours (Days 6-21) after ADC administration). 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 5 Nov 2026.