None listed
Conditions
Interventions
Design 1: For those patients eligible to complete the totality of neoadjuvant chemotherapy. This group will be treated with Trastuzumab, at a loading dose of 8 mg / kg IV, followed by a dose of 6 mg / kg, IV, every 3 weeks for a total of 52 weeks (1 year).
Design 2: For those patients subject to the adjuvant scheme who will receive a taxane together with the proposed drugs. Paclitaxel, at a dose of 80 mg / m2, IV, every week for 12 weeks, concomitantly: Trastuzumab, at a loading dose of 4 mg
Design 1: For those patients eligible to complete the totality of neoadjuvant chemotherapy. This group will be treated with Lapatinib, at a dose of 1500 mg, PO, QD for a total of 52 weeks. Concomitantly: Trastuzumab, at a loading dose of 8 mg / kg, followed by a dose of 6 mg / kg, IV, every 3 weeks for a total of 52 weeks (1 year).
Design 2: For those patients subject to the adjuvant scheme who will receive a taxane together with the proposed drugs. Paclitaxel, at a dose of 80 mg / m2, IV, ev
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ≥18 years. 2. Degree of activity ≤ 1 according to the Eastern Cooperative Oncology Group (ECOG). 3. Metastatic invasive primary non-metastatic mammary adenocarcinoma that: a) Is confirmed histologically. b) Be removed in an appropriate manner. c) Axillary dissection. d) It is a subject with a positive axillary lymph node diagnosis OR a subject with a diagnosis of a negative axillary ganglion with a tumor greater than or equal to 1.0 cm. 4. State of known hormone receptor. 5. Have received at least four cycles of a neoadjuvant chemotherapy regimen with approved anthracycline. 6. LVEF ≥ 50% basal. 7. Overexpression and / or amplification of HER2 in the invasive component of the primary tumor. 8. Complete all laboratory tests and baseline radiological investigations as necessary. 9. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of any previous invasive mammary carcinoma. 2. Past or current history of malignant neoplasms. 3. Any tumor considered clinically at stage T4. 4. Bilateral tumors. 5. Multifocal tumors. 6. Maximum cumulative dose of doxorubicin> 360 mg / m2 or maximum cumulative dose of epirubicin> 720 mg / m2 or any previous anthracycline not related to current breast cancer. 7. Chemotherapy (neo) adjuvant in which support of peripheral hemocytoblasts or myelohemocytoblasts is used. 8. Any previous mediastinal radiation. 9. Subjects with positive diagnosis of internal mammary nodes or suspicion thereof. 10. Previous use of anti-HER2 therapy for any reason or other biological therapy or immunotherapy to treat breast cancer; 11. Concurrent antineoplastic treatment. 12. Concurrent antineoplastic treatment in another research study with hormonal therapy or immunotherapy. 13. Severe heart disease or clinical condition that includes: a) Documented history of congestive heart failure (CHF) or systolic failure. b) Uncontrolled arrhythmias of high risk. c) Angina of the chest that requires antianginal medication. d) Clinically significant valvular heart disease. e) Evidence of transmural infarction in the ECG. f) Hypertension with poor control. 14. Other concurrent serious pathologies that could interfere with the planned treatment. 15. Any of the following laboratory tests with abnormal results: a) Total serum bilirubin> 2.0 x normal upper limit (ULN). b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 2.5 x ULN. c) Alkaline phosphatase (ALP)> 2.5 x ULN. d) Serum creatinine> 2.0 x ULN. e) Total leukocyte count (WBC) <2.5 x 10-9 / L. f) Absolute neutrophil count <1.5 x 10-9 / L. g) Platelets <100 x 10-9 / L. 16. Serious adverse events that are unresolved or unstable due to adjuvant chemotherapy or prior radiotherapy. 17. Malabsorption syndrome, a disease that significantly affects gastrointestinal function, or resection of the stomach or small intestine or people who can not take oral medication. Also subjects with ulcerative colitis will be excluded. 18. Pregnant or lactating women. 19. Women with fertile potential and men whose partners have fertile potential, who can not or refuse to use adequate contraceptive methods during the treatment of this study. 20. Concomitant use of CYP3A4 inhibitors or inducers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Determination of the time from the random distribution to the first appearance of: 1) Recurrence of breast cancer in any area (assessed by CT or MRI, radiography, bone scan, physical examination, biopsy), 2) A second primary cancer (contralateral breast) - invasive or DCIS - or non-mammary tumor) or 3) Death from any cause as the first event. Measure:Disease free survival (DFS). Timepoints:When the event is presented during the follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Medical evaluation of any undesirable medical event, product of the administration of the study drug. They will be classified according to their severity, using: CTCAE v3.0 of the NCI. Criterion 2: Identification and evaluation according to medical criteria of deaths due to cardiac reasons, severe congestive heart failure and significant decreases in the fraction of expulsion of the left ventricle. Measure:1) Adverse events. 2) Cardiac assessment criteria. Timepoints:When the event is presented, during the follow-up. ; Outcome name:Criterion 1: Determination of time from randomization to recurrence of breast cancer, without counting second primary cancers. Criterion 2: Determination of the time from the random distribution to the first distant recurrence of breast cancer, not counting locoregional recurrence or the second primary cancer types. Criterion 3: Determination of time from random distribution to death from any cause. Measure:1) Time to recurrence (TTR). 2) Time to distant recurrence (TTDR). 3) Overall survival (OS). Timepoints:When the event is presented, during the follow-up. ; Outcome name:- Determination of the amplification of the oncogene cMYC and HER2. - Levels of expression of PTEN (Phosphatase and homologous tensin suppressed in the chromosome of 10). - Presence of the receptor p95HER2. Measure:Pharmacogenetics. Timepoints:Before starting the treatment. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea South, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Outcome results
None listed