Trial · NCT07578116
Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis
NCT07578116, Phase 3, Recruiting, SWOG Cancer Research Network
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis. Trials, record NCT07578116. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07578116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis
- NCT number
- NCT07578116
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 562 participants, estimated
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Positive Breast Carcinoma, Oligometastatic Breast Carcinoma
- Interventions
Biopsy Procedure, Biospecimen Collection, Breast Conservation Treatment, Computed Tomography, Cyclin-Dependent Kinase 4 Inhibitor, Cyclin-Dependent Kinase 6 Inhibitor, Echocardiography Test, HER2-targeted Therapy, Hormone Therapy, Magnetic Resonance Imaging, Mammography, Pertuzumab, Positron Emission Tomography, Radiation Boost, Radiation Therapy, Stereotactic Body Radiation Therapy, Stereotactic Radiosurgery, Taxane Compound, Total Mastectomy, Trastuzumab, Trastuzumab Deruxtecan, Trastuzumab Emtansine, Ultrasound Imaging
- First posted
- 2026-05-11
- Last updated
- 2026-10-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) (Cohort A) | From date of Step 2 registration to date of death, assessed up to 10 years | The primary analysis to evaluate the primary objective in the randomized cohort will be an intent-to treat (ITT) comparison of Arm 1 versus Arm 2 using a stratified log-rank test including all randomized, eligible participants. The hazard ratio and 95% confidence interval (CI) will be estimated by Cox regression including the stratification factors as variables in the model. Primary analyses will be repeated among individuals with brain metastases to understand whether the effect of the intervention differs in this subgroup. |
| Primary | Progression-free survival (PFS) (Observational Cohort B) | From date of Step 2 registration to date of first documentation of progression or recurrence or death, assessed at 3 and 5 years | In the observational cohort, the primary objective will be evaluated by estimating 3- and 5-year survival and corresponding 95% CIs using the Kaplan-Meier estimator. All analyses in the observational cohort will be descriptive. Primary analyses will be repeated among individuals with brain metastases to understand whether the effect of the intervention differs in this subgroup. |
| Primary | Overall survival (Observational Cohort B) | From date of Step 2 registration to date of death, assessed at 3 and 5 years | In the observational cohort, the primary objective will be evaluated by estimating 3- and 5-year survival and corresponding 95% CIs using the Kaplan-Meier estimator. All analyses in the observational cohort will be descriptive. Primary analyses will be repeated among individuals with brain metastases to understand whether the effect of the intervention differs in this subgroup. |
| Secondary | Progression free survival (Cohort A) | From date of Step 2 registration to date of first documentation of progression or recurrence or death, assessed at 3 and 5 years and then up to 10 years | The primary analysis will be an ITT comparison of Arm 1 versus Arm 2 using a stratified log-rank test including all randomized, eligible participants. The hazard ratio and 95% CI will be estimated by Cox regression including the stratification factors as variables in the model. In addition to the primary analyses, will estimate PFS at 3 years and 5 years in Arm 1 and Arm 2 and corresponding 95% CIs using the Kaplan-Meier estimator. |
| Secondary | Overall survival (Cohort A) | From date of Step 2 registration to date of death, assessed at 3 and 5 years and then up to 10 years | The primary analysis will be an ITT comparison of Arm 1 versus Arm 2 using a stratified log-rank test including all randomized, eligible participants. The hazard ratio and 95% CI will be estimated by Cox regression including the stratification factors as variables in the model. In addition to the primary analyses, will estimate OS at 3 years and 5 years in Arm 1 and Arm 2 and corresponding 95% CIs using the Kaplan-Meier estimator. |
| Secondary | Duration of standard of care first line systemic therapy (Cohort B) | From time of response assessment at end of Step 1 up to 10 years |
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.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07578116
GET https://conductscience.org/api/trials/v1/NCT07578116/registered