Patients with HER2 -positive (IHC 3+ and /or ISH+) operable primary invasive breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Trastuzumab emtansine (genetical recombination)
INN of investigational material : trastuzumab emtansine
Therapeutic category code : 429 Other antitumor a
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients, >/= 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status /= 1), any tumor size except T0, and any hormonal receptor status, or Node-negative disease (pN0) with pathologic tumor size >2.0 cm by standard local assessment AND negative for ER and PR determined by a central pathology laboratory - 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 echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans - Female patients of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception. For male patients with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 7 months after the last dose of study treatment
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 randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin - 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 radiation therapy (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 - Cardiopulmonary dysfunction as defined by protocol - Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease - Significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia - Myocardial infarction within 12 months prior to randomization - Uncontrolled hypertension - Evidence of transmural infarction on ECG - Requirement for oxygen therapy - Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV - Any known active liver disease. For patients who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines. - Inadequate hematologic, renal or liver function - Pregnant or lactating women - Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol - Chronic immunosuppressive therapies, including systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Endpoints:To compare invasive disease-free survival (IDFS) Method:Invasive disease-free survival (IDFS), defined as time from randomization to occurrence of ipsilateral breast cancer recurrence, second primary invasive breast cancer, distant recurrence, or death of any cause [Time Frame: up to approximately 10 years ] [Designated as safety issue: No] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - IDFS plus second primary non-breast cancer, excluding non-melanoma skin cancers and carcinoma in situ of any site [Time Frame: up to approximately 10 years] [Designated as safety issue: No] - Disease-free survival (DFS), defined as the time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS) [Time Frame: up to approximately 10 years] [Designated as safety issue: No] - Distant recurrence-free interval (DRFI), defined as the time between randomization and the first occurrence of distant breast cancer recurrence [Time Frame: up to approximately 10 years] [Designated as safety issue: No] - Overall survival [Time Frame: up to approximately 10 years] [Designated as safety issue: No] - Safety: Incidence of adverse events [Time Frame: up to approximately 10 years] [Designated as safety issue: No] | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed