Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
AC Camargo Cancer Center
80 participants
Mar 1, 2021
INTERVENTIONAL
Conditions
Summary
Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor cells will be collected at neoadjuvant therapy baseline. Patients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group A, with HER2 positive CTCs and group B, with HER2 negative/absent CTCs.
Eligibility
Inclusion Criteria8
- HER2 positive breast cancer (hormone receptors positive or negative)
- Stage I to III
- Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab
- Breast surgery after neoadjuvant therapy
- Preserved coagnition
- ECOG 0-3
- For the randomization phase: pathological complete response (ypT0/ypTis and ypN0)
- Agreement on participation and signature of de ICF
Exclusion Criteria3
- Contradindication for trastuzumab or pertuzumab
- Adjuvant chemotherapy. Hormone therapy is allowed
- Second primary tumor \< 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer
Interventions
Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)
Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04993014