Trial · NCT07454668
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
NCT07454668, Phase 1, Not yet recruiting, Baptist Health South Florida
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases. Trials, record NCT07454668. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07454668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
- NCT number
- NCT07454668
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Baptist Health South Florida
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Brain Metastases, Cancer, Cancer Metastatic
- Interventions
- Trastuzumab Deruxtecan, Stereotactic Radiosurgery
- First posted
- 2026-03-06
- Last updated
- 2026-10-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) | 3 weeks | DLTs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 starting from the first dose of T-DXd through 3 weeks after SRS. DLT is defined as the appearance of side effects during treatment that are severe enough to prevent continuation of treatment at a participant's assigned dose. Any of the following events will be considered a DLT if treatment-related: * ≥ Grade 4 non-hematologic toxicity except nausea and vomiting (if manageable with supportive care measures), alopecia, drug-related fever, and toxicities secondary to neutropenia and sepsis * ≥ Grade 3 neurologic toxicity (sensory or autonomic) * Grade 4 platelet count (\<25,000/mm³) 50 days beyond the start of the most recent chemotherapy (not related to recurrent leukemia) * Grade 4 neutropenia 50 days beyond the start of the most recent chemotherapy (not related to recurrent leukemia) * Grade 3 non-hematologic toxicity (excluding alopecia or toxicities secondary to neutropenia |
| Primary | Determination of the maximum tolerated dose (MTD) of T-DXd in combination with SRS | 3 weeks | The MTD will be determined using a standard 3+3 dose de-escalation design across predefined dose levels of T-DXd (5.4 mg/kg, 4.4 mg/kg, and 3.2 mg/kg IV every 21 days), based on the number of participants who experience a DLT at each dose level. |
| Secondary | Intracranial Progression-free survival (PFS) at 6 months (PFS-6) | 6 months | Intracranial PFS-6 will be defined as the time from first dose of study drug until intracranial disease progression (i.e., progression within the skull) or death from any cause using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at 6 months post-treatment. Progression is defined as at least 20% increase in the sum of the longest diameters of the target lesions, appearance of any new lesions, or unequivocable progression of any non-target lesions. For participants whose disease has not progressed at the time of the analysis, censoring will be performed using the date of the last valid disease assessment. |
| Secondary | Extracranial PFS-6 | 6 months | Extracranial PFS-6 will be defined as the time from first dose of study drug until extracranial disease progression (i.e., progression outside of the skull) or death from any cause using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at 6 months post-treatment. Progression is defined as at least 20% increase in the sum of the longest diameters (LD) of the target lesions compared to the smallest recorded LD since treatment started, appearance of any new lesions, or unequivocable progression of any non-target lesions. For participants whose disease has not progressed at the time of the analysis, censoring will be performed using the date of the last valid disease assessment. |
| Secondary | Overall survival (OS) | 2 years | Median OS will be defined as the time from the beginning of study drug treatment until death due to any cause at the end of the study (\~2 years). For participants who have not died at the time of the analysis, censoring will be performed using the date the participant was last known to be alive. |
| Secondary | Objective response rate (ORR) | 2 years | ORR will be defined as the proportion of participants achieving a complete response (CR) or partial response (PR) using RECIST v1.1 as their best overall response by the end of the study (\~2 years). Participants with CR or PR will be counted as successes and all other participants (including those with missing response information) will be counted as failures. CR is defined as disappearance of all target and non-target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is defined as at least 30% decrease in the sum of the LD of target lesions compared to baseline. There can be no appearance of new lesions. |
| Secondary | Intracranial PFS-6 comparison to historical data | 6 months | Intracranial PFS-6 as defined in Outcome 3 will be compared to historical data. |
| Secondary | Extracranial PFS-6 comparison to historical data | 6 months | Extracranial PFS-6 as defined in Outcome 4 will be compared to historical data. |
| Secondary | OS comparison to historical data | 2 years | Median OS as defined in Outcome 5 will be compared to historical data. |
| Secondary | ORR comparison to historical data | 2 years | ORR as defined in Outcome 6 will be compared to historical data. |
Source ClinicalTrials.gov
Outcomes0
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/NCT07454668
GET https://conductscience.org/api/trials/v1/NCT07454668/registered