None listed
Conditions
Interventions
The first dose of study treatment will be administered on Day 1 of a cycle of 3 weeks, i.e. administration of the dose was repeated once Q3W up to a maximum of 14 treatment cycles. Treatment was disco
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. HER2-positive breast cancer 2. Confirmed invasive breast carcinoma from histologically. 3. Clinical stage at the time of presentation: T1-4, N0-3, M0 (Note: Patients with tumors T1a/bN0 not be suitable). 4. Completion of preoperative systemic treatment consisting of at least 6 cycles with a total duration of at least 16 weeks including at least 9 weeks of trastuzumab and at least 9 weeks of taxane based chemotherapy. 5. Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows: breast surgery, lymph node surgery: 6. Pathological evidence of residual invasive carcinoma or breast axillary lymph nodes after completion of preoperative therapy. 7. An interval of no more than 12 weeks from the date of surgery to the date of randomization. 8. Known hormone receptor status The positive hormone receptor status can be determined by known positive ER or PgR status known positive, hormone receptor status should be determined by negative negative ER and PgR negative known known. 9. Signed written informed consent approved by the Institutional Review Board (IRB) / Ethics Committee (EC) of the study center. 10. Age> 18 years. 11. Functional status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 12. Life expectancy  6 months. 13. Proper functioning of the organs during selection. 14. Women of childbearing potential and men whose partners are of childbearing potential must be willing to use a non-hormonal contraceptive two highly effective or effective nonhormonal contraceptive methods, either the patient and / or partner, and continue to use them for the duration study treatment and for 6 months after the last dose of study treatment. 15. Serum pregnancy test negative for premenopausal women, including women who have had a tubal ligation and in the case of women with less than 12 months after the onset of menopause. 16. It serology requires documentation of the hepatitis B virus (HBV) and hepatitis C virus (HCV): this includes HB surface antigen (HBsAg) and / or Total HB core antibody (anti-HBc) plus antibody test for HCV. The latest serology test should be done in the span of three months before the start of neoadjuvant therapy. If the test has not been performed, should be carried out during the selection.
Exclusion criteria
Exclusion criteria: 1. Breast Cancer Stage IV (metastatic) 2. History of a prior breast cancer (ipsilateral or contralateral), except for LCIS 3. Evidence of recurrent or residual disease macroscopically evident from the clinical viewpoint after preoperative therapy and surgery 4. Progressive disease (PD) during the preoperative therapy 5. Treatment with any investigational drug against cancer in the span of 28 days before the start of study treatment. 6. History of other malignancies in the span of the last five years, except for carcinoma in situ (CIS) of the cervix, non-melanoma skin cancer, uterine cancer in Stage I or other malignancies other than adequately treated breast , with a result similar to those mentioned above 7. Which patients would recommend radiation therapy for breast cancer, but for whom it is contraindicated for medical reasons (eg. Connective tissue disorders or previous ipsilateral breast radiation) 8. Peripheral neuropathy current  Grade 2 according to the NCI CTCAE (Version 4.0) 9. History of exposure to cumulative doses of anthracyclines following:  doxorubicin 240 mg/m2  480 mg/m2 epirubicin For other anthracyclines, doxorubicin exposure equivalent to 240 mg/m2  10. Cardiopulmonary dysfunction, as defined by any of the following: History of congestive heart failure (CHF)  symptomatic Grade 3 according to NCI CTCAE (Version 4.0) or Class II  according to the criteria of the Heart Association of New York (New York Heart Association, NYHA) Angina pectoris requiring medication for angina, serious arrhythmia not controlled by appropriate medications, severe conduction abnormality or significant valvular disease from the clinical standpoint • uncontrolled arrhythmias high risk: ie atrial tachycardia with a heart rate at rest  100/minute, significant ventricular arrhythmia (ventricular tachycardia) or higher degree AV block (second-degree AV block Type 2 [Mobitz 2] or third-degree AV block) Significant symptoms ( Grade 2) related to left ventricular dysfunction, cardiac arrhythmia or cardiac ischemia during or from receiving preoperative therapy History LVEF decreased to 40%  pretreatment with trastuzumab (eg. During preoperative therapy) Uncontrolled hypertension (systolic blood pressure 180 mmHg  and / or diastolic blood pressure 100 mmHg ) Evidence of transmural infarction in the ECG Necessity of continuous oxygen therapy 11. Previous treatment with trastuzumab emtansina 12. Uncontrolled systemic disease, severe, ongoing (eg. Cardiovascular disease, pulmonary or metabolic significant from a clinical standpoint, disorders of wound healing, ulcers) 13. In the case of female patients, pregnancy and / or lactation period 14. Major surgical procedure unrelated to breast cancer or significant traumatic injury within about 28 days before randomization or anticipation of the need for major surgery during the course of study treatment 15. Any known active liver disease, for example, due to HBV, HCV, autoimmune hepatic disorders or sclerosing cholangitis. Patients with HBV or HCV serology positive no known active disease must meet the eligibility criteria with respect to the ALT, AST, Tbili, INR, aPTT and alkaline phosphatase (ALK) at least two consecutive occasions, with at least 1 week of separation between them, within a selection period of 30 days.
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Korea North, Korea South, Lithuania, Malasya, Netherlands, Norway, Panama, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States, Uruguay
Contacts
Public ContactJORGE MANUEL TIMOTEO
ROCHE FARMA (PERU) S.A.
Outcome results
None listed