Trial · NCT07178730
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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: |
| Secondary | Health-related quality of life (HRQoL)via CANKADO active | 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-C30, version 3.0, | Cohort II: end of the neoadjuvant treatment, at clinical response assessment, at cycle 3 of prolonged neoadjuvant treatment, at surgery, at start 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 | HRQoL via questionnaires EORTC QLQ-BR42 | Cohort II: end of the neoadjuvant treatment, at clinical response assessment, at cycle 3 of prolonged neoadjuvant treatment, at surgery, at start of post-neoadjuvant treatment, 3-monthly during follow-up | Change of HRQoL between baseline, after completion of SoC neoadjuvant treatment, and on following defined timepoints: |
| Secondary | HRQoL via CANKADO active | Cohort II: end of the neoadjuvant treatment, at clinical response assessment, at cycle 3 of prolonged neoadjuvant treatment, at surgery, at start of post-neoadjuvant treatment, 3-monthly during follow-up | Change of HRQoL between baseline, after completion of SoC neoadjuvant treatment, and on following defined timepoints: |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT07178730/registered