Breast Cancer: triple negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2 negative breast cancer
Conditions
Brief summary
Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0, Event-Free Survival (EFS)
Detailed description
Overall Survival (OS), pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0, pCR (ypT0/Tis ypN0) in Participants with High-Risk, Early-Stage, Triple Negative Breast Cancer (TNBC), EFS in Participants with High-Risk, Early-Stage, TNBC, OS in Participants with High-Risk, Early-Stage, TNBC, Distant Progression or Distant Recurrence-Free Survival (DPDRFS), Change from Baseline in the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score, Change from Baseline in EORTC-QLQ-C30 Physical Functioning Score, Change from Baseline in EORTC QLQ-C30 Role Functioning Score, Change from Baseline in EORTC QLQ-C30 Fatigue Score, Change from Baseline in EORTC QLQ-Breast Cancer Questionnaire (BR42) Systemic Therapy Side Effects, Number of Participants with One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Intervention Due to an AE
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0, Event-Free Survival (EFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS), pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0, pCR (ypT0/Tis ypN0) in Participants with High-Risk, Early-Stage, Triple Negative Breast Cancer (TNBC), EFS in Participants with High-Risk, Early-Stage, TNBC, OS in Participants with High-Risk, Early-Stage, TNBC, Distant Progression or Distant Recurrence-Free Survival (DPDRFS), Change from Baseline in the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score, Change from Baseline in EORTC-QLQ-C30 Physical Functioning Score, Change from Baseline in EORTC QLQ-C30 Role Functioning Score, Change from Baseline in EORTC QLQ-C30 Fatigue Score, Change from Baseline in EORTC QLQ-Breast Cancer Questionnaire (BR42) Systemic Therapy Side Effects, Number of Participants with One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Intervention Due to an AE | — |
Countries
Belgium, Finland, France, Greece, Hungary, Poland, Portugal, Spain, Sweden