Stage II-IIIA operable breast cancer, HER2 positive and hormone receptor-positive, previously untreated MedDRA version: 14.1 Level: LLT Classification code 10072740 Term: Locally advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: PERJETA
Product Name: Pertuzumab
Pharmaceutical Form: Solution for infusion
Sponsors
AS.T.R.O.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Patients may be included in the study only if they met all the following criteria - female patients with primary diagnosis of infiltrating breast cancer - HR positivity (ER = 10% and/or PgR =10%) and HER2 positivity (IHC 3+ or FISH/CISH amplification) as assessed by local laboratory - Stage II-IIIA - age >18 yrs - ECOG Performance Status 0-1 - Postmenopausal status, defined by at least one of the following: 60 years of age; /=12 months prior to day 1 =3000/mcL; absolute neutrophil count >=1,500/mcL; platelets >=100,000/mcL; total bilirubin within 1.25 x normal institutional limits (with the exception of Gilbert’s syndrome); AST (SGOT)/ALT(SGPT) within 1.25 x institutional upper limit of normal creatinine within normal institutional limits - Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment - Ability to understand and the willingness to sign a written informed consent document. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study for any of the following reasons - Stage IIIB, IIIC, and inflammatory breast cancer - Stage IV breast cancer - Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with HER2 targeting therapies - LVEF below the ULN - Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) grade II or higher, or serious cardiac arrhythmia requiring medication. - Received any investigational treatment within 4 weeks of study start. - Subjects with known infection with HIV, HBV, HCV - Known hypersensitivity to any of the study drugs or excipients. - Dyspnea at rest or other disease requiring continuous oxygen therapy. - Psychiatric illness/social situations that would limit compliance with study requirements - Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To estimate the percentage of clinical objective responses (cOR) (complete plus partial) in the breast, as assessed by ultrasonography (US) - To estimate the percentage of breast conservative surgery - To evaluate the safety profile - Correlative biomarker analyses ;Timepoint(s) of evaluation of this end point: at the time of surgery | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the rate of pathologic complete response (pCR), as defined as complete disappearance of invasive tumor in breast and axillary nodes;Secondary Objective: - To estimate the percentage of clinical objective responses (cOR) (complete plus partial) in the breast, as assessed by ultrasonography (US) - To estimate the percentage of breast conservative surgery - To evaluate the safety profile - Correlative biomarker analyses ;Primary end point(s): to evaluate the rate of pathologic complete response (pCR), as defined as complete disappearance of invasive tumor in breast and axillary nodes;Timepoint(s) of evaluation of this end point: at the time of surgery | — |
Countries
Italy
Contacts
Public ContactGian Luca De Salvo
Istituto Oncologico Veneto
Outcome results
None listed