Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Trastuzumab
- Conditions
- Breast Neoplasms
- Sponsor
- AC Camargo Cancer Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- HER2 therapy disease-free survival
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
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
Investigators
Marcelle Goldner Cesca
Clinical Oncologist
AC Camargo Cancer Center
Eligibility Criteria
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
- •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
Arms & Interventions
Cohort 1, Arm A - trastuzumab
Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline
Intervention: Trastuzumab
Cohort 1, Arm A - trastuzumab
Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline
Intervention: Circulating tumor cells
Cohort 1, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
Intervention: Pertuzumab
Cohort 1, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
Intervention: Trastuzumab
Cohort 1, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
Intervention: Circulating tumor cells
Cohort 2, Arm A - trastuzumab
Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline
Intervention: Trastuzumab
Cohort 2, Arm A - trastuzumab
Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline
Intervention: Circulating tumor cells
Cohort 2, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
Intervention: Pertuzumab
Cohort 2, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
Intervention: Trastuzumab
Cohort 2, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
Intervention: Circulating tumor cells
Outcomes
Primary Outcomes
HER2 therapy disease-free survival
Time Frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
CTCs disease-free survival
Time Frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs
Secondary Outcomes
- Correlation of CTCs and pathological complete response(At baseline)
- Prognostic factors for disease-free survival(At baseline and adjuvant therapy (18 months))
- Adverse events(Adjuvant period (1 year))