breast cancer
Conditions
Brief summary
TNBC and HER2+: - pCR rates in the de-escaltated Arm A1 HR+/HER2−: DFS in overall HER2-/HR+ cohort and in each risk category. - Proportion of patients in each OncotypeDX genomic risk categories (low, intermediate, high) and correlation with KI67 values before and after short term endocrine treatment
Detailed description
TNBC and HER2+ : - pCR and near pCR (RCB1) rates in each Arm. - Proportion of de-escalated patients. - Disease free (DFS), distant disease free (DDFS) and overall survival (OS). - Safety and toxicity profile (Incidence of grade 2 and ≥3 AEs; biopsy/MRI-related AEs) - QoL PROs questionnaire (EORTC QLQ-C30, QLQ-BR45, Decision Regret Scale) HR+/HER2− - DDFS and OS. - Safety and toxicity profile (Incidence of grade 2 and ≥3 AEs) - QoL PROs questionnaire (EORTC QLQ-C30, QLQ-BR45, Decision Regret
Interventions
DRUGKisqali 200 mg film-coated tablets
DRUGTamoxifene-ratiopharm 20 mg compresse rivestite con film
DRUGXeloda 150 mg film-coated tablets
DRUGLetrozole 2.5 mg Film-coated Tablets
DRUGDocetaxel 80 mg/4 ml concentrate for solution for infusion
DRUGFARMORUBICINA 50 mg Polvere per Soluzione per Infusione
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.
DRUGPaclitaxel 6 mg/ml concentrate for solution for infusion
DRUGPerjeta 420 mg concentrate for solution for infusion
Sponsors
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNBC and HER2+: - pCR rates in the de-escaltated Arm A1 HR+/HER2−: DFS in overall HER2-/HR+ cohort and in each risk category. - Proportion of patients in each OncotypeDX genomic risk categories (low, intermediate, high) and correlation with KI67 values before and after short term endocrine treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| TNBC and HER2+ : - pCR and near pCR (RCB1) rates in each Arm. - Proportion of de-escalated patients. - Disease free (DFS), distant disease free (DDFS) and overall survival (OS). - Safety and toxicity profile (Incidence of grade 2 and ≥3 AEs; biopsy/MRI-related AEs) - QoL PROs questionnaire (EORTC QLQ-C30, QLQ-BR45, Decision Regret Scale) HR+/HER2− - DDFS and OS. - Safety and toxicity profile (Incidence of grade 2 and ≥3 AEs) - QoL PROs questionnaire (EORTC QLQ-C30, QLQ-BR45, Decision Regret | — |
Outcome results
None listed