Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
NCT07918079, Phase 2, Not yet recruiting, Fudan University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy | ClinicalTrials.gov |
| NCT number | NCT07918079 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 84 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fudan University | ClinicalTrials.gov |
| Conditions | Breast Cancer | ClinicalTrials.gov |
| Interventions | Netupitant and Palonosetron, Dexamethasone, Olanzapine 5 Mg ORAL TABLET | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percentage of Participants with No Nausea (VAS < 5 mm) During the 120-504 Hour Window After ADC Administration | 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. | ClinicalTrials.gov |
| Secondary | Percentage of Participants with No Significant Nausea (VAS < 25 mm) During the 120-504 Hour Window | 120-504 hours (Days 6-21) after ADC administration | Proportion of participants with a VAS nausea score \< 25 mm during the 120-504 hour window after ADC administration. | ClinicalTrials.gov |
| Secondary | Percentage of Participants with No Vomiting During the 120-504 Hour Window | 120-504 hours (Days 6-21) after ADC administration | Proportion of participants who did not experience vomiting during the 120-504 hour window after ADC administration. | ClinicalTrials.gov |
| Secondary | Complete Response (CR) Rate During the 120-504 Hour Window | 120-504 hours (Days 6-21) after ADC administration | 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.) | ClinicalTrials.gov |
| Secondary | Complete Protection (CP) Rate During the 120-504 Hour Window | 120-504 hours (Days 6-21) after ADC administration | 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.) | ClinicalTrials.gov |
| Secondary | Total Control (TC) Rate During the 120-504 Hour Window | 120-504 hours (Days 6-21) after ADC administration | 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.) | ClinicalTrials.gov |
| Secondary | Antiemetic Efficacy Across Time Windows: No Nausea, No Significant Nausea, No Vomiting, CR, CP, TC, and Rescue Medication Rates | Acute phase 0-24 h; delayed phase 24-120 h; overall 0-120 h; full course 0-504 h (Day 1-21) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)