Last updated 5 years ago
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
80 patients around the world
Available in Brazil
Patients with HER2 positive breast cancer (hormone receptors positive or negative), which are candidate to neoadjuvant therapy with pertuzumab and trastuzumab will be included.
Blood samples will be collected at baseline (before neoadjuvant start) for the analysis of CTCs and its positivity for HER2 by IHC and ISH.
Patients with pathological complete response will be included in the randomization phase of the study. There will be 2 cohorts: HER2 positive CTCs at baseline and HER2 negative/absent CTCs at baseline. In each cohort, patients will be randomized in 1:1 ratio for adjuvant trastuzumab versus adjuvant trastuzumab + pertuzumab
AC Camargo Cancer Center
1Research sites
80Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- HER2 positive breast cancer (hormone receptors positive or negative)Stage I to IIIIndication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumabBreast surgery after neoadjuvant therapyPreserved coagnitionECOG 0-3For the randomization phase: pathological complete response (ypT0/ypTis and ypN0)Agreement on participation and signature of de ICF
- Contradindication for trastuzumab or pertuzumabAdjuvant chemotherapy. Hormone therapy is allowedSecond primary tumor < 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer
Sites
AC Camargo Cancer Center
Recruiting
StudyHER2Cell
SponsorAC Camargo Cancer Center
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04993014
