A Phase 2 interventional study of Pertuzumab and Trastuzumab in Breast Neoplasms, HER2-positive Breast Cancer and Circulating Tumor Cell, sponsored by AC Camargo Cancer Center. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by AC Camargo Cancer Center · Phase 2, Interventional, and Treatment
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.
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
Exclusion Criteria:
Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline
Drug: Trastuzumab · Other: Circulating tumor cells
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
Drug: Pertuzumab · Drug: Trastuzumab · Other: Circulating tumor cells
Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline
Drug: Trastuzumab · Other: Circulating tumor cells
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
Drug: Pertuzumab · Drug: Trastuzumab · Other: Circulating tumor cells
Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)
Also known as: Perjeta
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
Also known as: Zedora
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
Also known as: CTCs
HER2 therapy disease-free survival
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
Time frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
CTCs disease-free survival
To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs
Time frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
Prognostic factors for disease-free survival
Time frame: At baseline and adjuvant therapy (18 months)
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
Time frame: At baseline
Adverse events
To compare the adverse events between trastuzumab and trastuzumab + pertuzumab
Time frame: Adjuvant period (1 year)
Plan to share: No
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AC Camargo Cancer Center