Breast Neoplasms Clinical Trial
— HER2CellOfficial title:
Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | April 30, 2028 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | A.C. Camargo Cancer Center | São Paulo |
Lead Sponsor | Collaborator |
---|---|
AC Camargo Cancer Center |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HER2 therapy disease-free survival | To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms | From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years | |
Primary | CTCs disease-free survival | To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs | From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years | |
Secondary | Prognostic factors for disease-free survival | At baseline and adjuvant therapy (18 months) | ||
Secondary | Correlation of CTCs and pathological complete response | To evaluate if there is a correlation of HER2 positivity and the number of CTCs/ml and the pathological response | At baseline | |
Secondary | Adverse events | To compare the adverse events between trastuzumab and trastuzumab + pertuzumab | Adjuvant period (1 year) |
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