Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Neoplasms
Decision date
14/09/2026
Enrollment target
1
Sites
Italy
Condition studied
breast cancer
Investigational medicinal product(s)
Kisqali 200 mg film-coated tabletsTamoxifene-ratiopharm 20 mg compresse rivestite con filmXeloda 150 mg film-coated tabletsExemestane 25 mg Film-coated TabletsLetrozole 2.5 mg Film-coated TabletsDocetaxel 80 mg/4 ml concentrate for solution for infusionFARMORUBICINA 50 mg Polvere per Soluzione per InfusioneArimidex® 1 mg film-coated tabletsKEYTRUDA 25 mg/mL concentrate for solution for infusion.Ogivri 420 mg powder for concentrate for solution for infusionPaclitaxel 6 mg/ml concentrate for solution for infusionPerjeta 420 mg concentrate for solution for infusionCarboplatin-Teva 10 mg/ml Concentrate for Solution for InfusionKadcyla 160 mg powder for concentrate for solution for infusion.Verzenios 150 mg film-coated tabletsEndoxan Baxter 1 g Polvere per soluzione iniettabile
Eligibility
Age group
65+ years, 18-64 years
Sex
Female, Male
Primary endpoint
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
Endpoint detail
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
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.