Trial · NCT07178730
NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer
NCT07178730, Phase 3, Not yet recruiting, Women's Cancer Study Group GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer. Trials, record NCT07178730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07178730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer
- NCT number
- NCT07178730
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 765 participants, estimated
- Lead sponsor
- Women's Cancer Study Group GmbH
- Conditions
- Breast Cancer, Triple-negative Breast Cancer
- Interventions
- Sacituzumab govitecan, Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA], SoC Chemotherapy
- First posted
- 2025-09-17
- Last updated
- 2026-08-05
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort I: 3-year event-free survival (EFS) | EFS 3 years | EFS after 36 months defined as time from registration to any invasive breast cancer event, death, or secondary malignancy (same definition as iDFS) according to STEEP 2.0 criteria \[103\] |
| Primary | Cohort II: superiority of neoadjuvant treatment with SG+PEM vs. SoC with regards to event-free survival (EFS) | EFS 3 years | EFS after 36 months defined as time from registration to any invasive breast cancer event, death, or secondary malignancy or local progress precluding surgery in neoadjuvant treated patients |
| Primary | Cohort II: superiority of neoadjuvant treatment with SG+PEM vs. SoC with regards to pathological complete response (pCR) rates | EFS 3 years | pCR defined as no invasive disease in breast and lymph nodes (ypT0/is, ypN0) in patients of both arms |
| Secondary | clinical response after 12 weeks of neoadjuvant chemotherapy treatment (NACT) | 12 weeks NACT | Clinical response measured by tumour size in mm by palpation, ultrasound, mammography, or MRI |
| Secondary | distant disease-free survival (dDFS) | 3 years | distant disease-free survival (dDFS) |
| Secondary | relapse-free survival (RFS) | 3 years | relapse-free survival (RFS) |
| Secondary | locoregional relapse-free survival (LRFS) | 3 years | locoregional relapse-free survival (LRFS) |
| Secondary | overall survival (OS) | 3 years | OS defined as time from first diagnosis to death |
| Secondary | Health-related quality of life (HRQoL) via questionnaires EORTC-QLQ-C30, version 3.0, | Cohort I: end of the neoadjuvant treatment, at clinical response assessment, at surgery, at start of post-neoadjuvant treatment, at cycle 3, at cycle 5, at end of post-neoadjuvant treatment, 3-monthly during follow-up | Change of Health-related quality of life (HRQoL)between baseline, after completion of SoC neoadjuvant treatment, and on following defined timepoints: |
| Secondary | Health-related quality of life (HRQoL)via questionnaires EORTC QLQ-BR42 | Cohort I: end of the neoadjuvant treatment, at clinical response assessment, at surgery, at start of post-neoadjuvant treatment, at cycle 3, at cycle 5, at end of post-neoadjuvant treatment, 3-monthly during follow-up | Change of Health-related quality of life (HRQoL)between baseline, after completion of SoC neoadjuvant treatment, and on following defined timepoints: |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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/NCT07178730
GET https://conductscience.org/api/trials/v1/NCT07178730/registered