Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Arm A - trastuzumab | Active Comparator | Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline |
|
| Cohort 1, Arm B - Trastuzumab + pertuzumab | Experimental | Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline |
|
| Cohort 2, Arm A - trastuzumab | Active Comparator | Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline |
|
| Cohort 2, Arm B - Trastuzumab + pertuzumab | Experimental | Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertuzumab | Drug | Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic factors for disease-free survival | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelle G Cesca, MD | Contact | +551121895000 | marcelle.cesca@accamargo.org.br | |
| Ludmilla TD Chinen, PhD | Contact | +551121895000 | ludmilla.chinen@accamargo.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Marcelle G Cesca, MD | A.C. Camargo Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.C. Camargo Cancer Center | Recruiting | São Paulo | 01525-001 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will be divided into 2 cohorts, based on HER2 positivity in CTCs at baseline of neoadjuvant therapy.
Cohort 1: HER2 positive CTCs: randomization to adjuvant trastuzumab versus trastuzumab + pertuzumab in patients with pathological complete response Cohort 2: HER2 negative/absent CTCs: randomization to adjuvant trastuzumab versus trastuzumab + pertuzumab in patients with pathological complete response
Not provided
Not provided
Not provided
Not provided
|
| Trastuzumab | Drug | 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 |
|
|
| Circulating tumor cells | Other | Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done. |
|
|
| At baseline |
| Adverse events | To compare the adverse events between trastuzumab and trastuzumab + pertuzumab | Adjuvant period (1 year) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided