Trial · NCT06462079
Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases
NCT06462079, Phase 2, Not yet recruiting, Guangzhou Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases. Trials, record NCT06462079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06462079
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases
- NCT number
- NCT06462079
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 43 participants, estimated
- Lead sponsor
- Guangzhou Medical University
- Conditions
- Brain Metastasis
- Interventions
- Sacituzumab Govitecan, Radiotherapy
- First posted
- 2024-06-17
- Last updated
- 2024-06-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1-year CNS progression-free survival (NPFS) | From the time patients receive this treatment until the next 1 year | Proportion of patients free of CNS progression at 1 year from the time the patient receives this treatment. Neurological progression was assessed according to the Response Assessment of Neuro-Oncology Brain Metastases (RANO-BM) criteria. |
| Secondary | Intracranial objective remission rate (IORR) | Assessed at 2 months after the end of treatment or at the time of patient death | The proportion of patients whose brain metastases shrink in volume to achieve complete remission/partial remission from the time the patient receives this treatment. Complete remission/partial remission is assessed according to the Response Assessment of Neuro-Oncology Brain Metastases (RANO-BM) criteria |
| Secondary | Rate of new intracranial lesions | Assessed 2 months after the end of treatment or at the time of patient's death | The proportion of patients presenting with new brain metastases from the time the patient received treatment. New brain metastases are assessed according to the Response Assessment of Neuro-Oncology Brain Metastases (RANO-BM) criteria. |
| Secondary | Overall progression-free survival (PFS) | All patients received at least 6 months of follow-up, and NPFS was assessed from the start of treatment to the date of the first documented progression of an extracranial lesion or the date of death from any cause, whichever came first. | The time from the time the patient receives this treatment to the time of disease progression or death. Assessment of extracranial lesions follows the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). |
| Secondary | Overall survival | Assessments were performed at least 7 months after diagnosis of brain metastases or before death | Survival time was recorded from the date of patient enrollment. All patients were followed until death or the end of the study. |
| Secondary | Incidence of Treatment-Related Adverse Events | Assessments were performed 2 months after the end of treatment or at the time of the patient's death | The incidence of treatment-related adverse events was measured to determine tolerability and safety. Adverse events (AEs) were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).Grade 3-5 events were defined as moderate and severe adverse events. |
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.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT06462079
GET https://conductscience.org/api/trials/v1/NCT06462079/registered