None listed
Conditions
Interventions
Research products to be used are: * Trastuzumab, doses: 6mg/kg weight, frequency: c/3sem. 4 cycles administered intravenously, FF: lyophilized for solution for injection
* Pertuzumab doses: 420mg, Frequency: c/3sem 4 cycles administered intravenously, FF: solution for injection, and trastuzumab emtansine *, 3.6mg / kg, frequency: c/3sem.4 cycles administered intraveno
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: * Age≥ 18 years • Eastern Cooperative Oncology Group performance status ≤1 • Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable • HER2−positive breast cancer prospectively determined on the primary tumor by a central pathology laboratory * Known hormone receptor status of the primary tumor determined by a central pathology laboratory * Adequately excised: patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy * Patients with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive. • No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization. • Baseline LVEF≥ 55% measured by ECHO (preferred) or MUGA scans • Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is required: this includes hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody (HBcAb) in addition to HCV antibody testing.
Exclusion criteria
Exclusion criteria: * History of any prior (ipsi- and/or contralateral) invasive breast carcinoma • History of non-breast malignancies within the 5 years prior to study entry * Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer * For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy (e.g., trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer RT (intraoperative radiotherapy as a boost at the time of primary surgery is acceptable) • Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy • History of DCIS and/or LCIS that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Patients who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study. • Patients with contraindication to RT while adjuvant RT is clinically indicated • Concurrent anti-cancer treatment in another investigational trial * Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV
Countries
Argentina, Australia, Austria, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, France, French Polynesia, Georgia, Germany, Guatemala, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Islas Marshall, Israel, Italy, Japan, Korea South, Malasya, Mexico, New Zealand, Panama, Philippines, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactRoberto Carrasco
ROCHE FARMA (PERU) S.A.
Outcome results
None listed