HER2-positive Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: HERCEPTIN - 150 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE ENDOVENOSA 1 FLACONCINO USO ENDOVENOSO
Product Name: Trastuzumab
Product Code: [RO0452317]
Pharmaceutical Form: Powde
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Previously untreated, infiltrating primary breast cancer with locally advanced, inflammatory, or early stage tumor (either greater than 2 cm in diameter or node positive) with no evidence of metastatic disease. • HER2 positivity (either immunohistochemistry 3+ or fluorescent in situ hybridization amplification). • Age 18 or older. • Eastern Cooperative Oncology Group performance status of 0 to 1. • Availability of tumor tissue for biologic and molecular examination before starting primary treatment. • Left ventricular ejection fraction within the institutional range of normal. • Normal organ and marrow function. • Adequate contraception methods for women of childbearing potential. • Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years. • Written informed consent. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Either stage I or IV breast cancer. • Prior trastuzumab or pertuzumab. • Any prior chemotherapy. • Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment. • Undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) <= 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery. • Breast radiotherapy prior to starting study. • Known hypersensitivity to the investigational drugs or any of their excipients. • Evidence of any disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or puts the patient at high risk for treatment-related complications. • Moderate/severe hepatic impairment (Child-Pugh B/C). • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. • Concurrent malignancy or malignancy within 3 years prior to study enrollment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix. • Pregnancy or breastfeeding (breast feeding should be discontinued to be enrolled in the study). • Women of childbearing potential that refusal to adopt adequate contraceptive measures. • Unwilling or unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: After completion of neoadjuvant treatment;Main Objective: To evaluate variations of host immune response parameters to either SC or IV neoadjuvant trastuzumab formulations in primary HER2-positive breast cancer.;Secondary Objective: To evaluate clinical efficacy, safety and tolerability of the combination regimens.;Primary end point(s): TIL rate on residual disease after either IV trastuzumab or SC trastuzumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate associations between biomarkers (TILs , TLA, and Fc¿R polymorphisms)and between each biomarker with clinical outcome variables ; To evaluate safety and tolerability of each treatment regimen, including pre-operative (neoadjuvant) and post-operative (adjuvant) treatment. Toxicities will be graded according to the NCI CTCAE version 4.0 and reported as cumulative incidence; C. To evaluate HRQOL during study treatment based on FACT-B: C1. Comparison between mean FACT-B scores assessed at enrolment and mean FACT-B scores assessed before surgery. C2. Comparison between treatment arms of FACT-B scores assessed at predefined time points and expressed as the area under the curve (AUC). ; To describe prognostic aspects of each treatment regimen based on: . Comparison of response rates between treatment arms: • complete pathological response rate • clinical response rate • breast conserving surgery rate ; Comparison of median survival times between treatment arms: • 5-year disease-free survival • 5-year progression-free survival • Time to clinical response ;Timepoint(s) of evaluation of this end point: at baseline and on residual disease; at each visit and at the endo of study; at baseline, before and after surgery, each 3 months and at the end of study; before surgery, at the end of study treatment; every 6 months up to 5 years | — |
Countries
Italy
Contacts
Public ContactMedical Oncology Unit, University H
GOIRC Gruppo Oncologico Italiano di Ricerca Clinica
Outcome results
None listed