Trial · NCT06238921
Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases
NCT06238921, Phase 1, Phase 2, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases. Trials, record NCT06238921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06238921
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases
- NCT number
- NCT06238921
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, estimated
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Interventions
- Stereotactic Radiation, Zimberelimab, Sacituzumab govitecan
- First posted
- 2024-02-02
- Last updated
- 2025-12-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Neurologic Toxicity | Up to 9 Weeks | Neurologic Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5). A Neurologic Toxicity will be defined as any Grade 3 or higher toxicity that occurs during the Dose Limiting Toxicity evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition. * Symptomatic radionecrosis, defined by surgical pathology or multidisciplinary evaluation. * Grade ≥ 3 headaches * Grade ≥ 3 memory impairment * New onset grade ≥ 3 seizures |
| Primary | Phase II: Progression Free Survival (PFS) | Up to 12 Months | Evaluate the PFS of SG and zimberelimab with SRS among patients with metastatic triple negative breast cancer. PFS is time from the date of start of treatment to the investigator-determined date of progression or death due to any cause, whichever occurs first. |
| Secondary | Phase II: Intracranial Progression Free Survival (PFS) | Up to 12 Months | Time from the date of start of treatment to the investigator-determined date of progression (determined by Response Assessment in Neuro-Oncology (RANO)) or death due to any cause, whichever occurs first. Progression is measured by a ≥ 20% increase in sum longest distance relative to nadir in target lesions and unequivocal or progressive disease in non-target lesions. |
| Secondary | Phase II: Extracranial Progression Free Survival (PFS) | Up to 33 Months | PFS will be measured from the date of start of treatment to the investigator-determined date of progression (determined by Immune-related Response Evaluation Criterial in Solid Tumors (irRECIST)) or death due to any cause, whichever occurs first. Progression is defined as ≥ 20% increase in tumor burden. |
| Secondary | Phase II: Overall Survival (OS) | Up to 33 Months | OS will be measured from the date of start of treatment to death. |
| Secondary | Phase II: Local Brain Control | Up to 33 Months | Number of participants with Local Brain Control will be determined from irradiated lesions according to RANO criteria. |
| Secondary | Phase II: Distant Brain Control | Up to 33 months | Number of participants with Distant Brain Control will be determined by the development of new lesions outside the irradiated area. |
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/NCT06238921
GET https://conductscience.org/api/trials/v1/NCT06238921/registered