Trial · NCT07134153
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
NCT07134153, Phase 1, Phase 2, Recruiting, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases. Trials, record NCT07134153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07134153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
- NCT number
- NCT07134153
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 139 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Breast Cancer
- Interventions
- T-DXd
- First posted
- 2025-08-21
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I Stage Cohort A: Maximum Tolerated Dose (MTD) | Up to 21 days after the first dose | Cohort A: Maximum Tolerated Dose (MTD) of intracapsular administration，In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD. |
| Primary | Phase I Stage Cohort B: Maximum serum concentration (Cmax) | Up to 21 days after the first dose | Cohort B: Maximum serum concentration (Cmax) of T-DXd in cerebrospinal fluid and blood will be investigated. |
| Primary | Phase I Stage Cohort B:Time to maximum serum concentration (Tmax) | Up to 21 days after the first dose | Cohort B: Time to maximum serum concentration (Tmax) of T-DXd in cerebrospinal fluid and blood will be investigated. |
| Primary | Phase I Stage Cohort B:Half-life (T1/2) | Up to 21 days after the first dose | Cohort B: Half-life (T1/2) of T-DXd in cerebrospinal fluid and blood will be investigated. |
| Primary | Phase II Stage Cohorts A: LM-OS | 18 months | Cohorts A: leptomeningeal metastasis-overall survival（LM-OS） |
| Primary | Phase II Stage Cohorts B: LM-OS | 18 months | Cohorts B: leptomeningeal metastasis-overall survival（LM-OS） |
| Primary | Phase II Stage Cohorts C: LM-ORR | 18 months | Cohorts C: leptomeningeal metastasis-Objective Response Rate（LM-ORR） |
| Primary | Phase II Stage Cohorts D: LM-ORR | 18 months | Cohorts D: leptomeningeal metastasis-Objective Response Rate（LM-ORR） |
| Primary | Phase II Stage Cohorts E: LM-OS | 18 months | Cohorts E: leptomeningeal metastasis-overall survival（LM-OS） |
| Primary | Phase II Stage Cohorts F: LM-OS | 18 months | Cohorts F: leptomeningeal metastasis-overall survival（LM-OS） |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07134153
GET https://conductscience.org/api/trials/v1/NCT07134153/registered