A Phase 2 interventional study of Netupitant and Palonosetron and Dexamethasone in Breast Cancer, sponsored by Fudan University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Fudan University · Phase 2, Interventional, and Prevention
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 84 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 18 years. 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.
(ECOG) performance status of 0-2. Expected survival ≥ 3 months.
Adequate organ function, defined as:
(ANC) ≥ 1.5 × 10⁹/L; count ≥ 100 × 10⁹/L; ≥ 90 g/L; Serum total ≤ 1.5 × ; and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver ); Serum creatinine ≤ 1.5 × ULN or ≥ 60 mL/min. Able to understand and voluntarily sign written . Able and willing to use an electronic patient-reported outcome (ePRO) device to complete daily diary records.
Exclusion Criteria:
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, , 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 of the NEPA capsule. Symptomatic or (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 ( ≥ 8.0%), (NYHA) functional classification ≥ III, myocardial infarction or unstable angina within 6 months, or history of 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Netupitant and Palonosetron · Drug: Dexamethasone · Drug: Olanzapine 5 Mg ORAL TABLET
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.
Drug: Netupitant and Palonosetron · Drug: Dexamethasone · Drug: Olanzapine 5 Mg ORAL TABLET
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.
Drug: Netupitant and Palonosetron · Drug: Dexamethasone · Drug: Olanzapine 5 Mg ORAL TABLET
Oral fixed-dose netupitant/palonosetron (NEPA) capsule (300 mg netupitant / 0.5 mg palonosetron), 1 capsule administered orally.
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 administered orally once daily on Days 1-4. No olanzapine is administered on Day 5 or during Days 6-21.
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.
Time frame: 120 to 504 hours (Days 6-21) after ADC administration
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.
Time frame: 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.
Time frame: 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.)
Time frame: 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.)
Time frame: 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.)
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
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.
Time frame: Acute phase 0-24 h; delayed phase 24-120 h; overall 0-120 h; full course 0-504 h (Day 1-21)
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.