None listed
Conditions
Interventions
Group 1 Type of group
oral lapatinib (1500 mg daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg / m2 iv) for 12 additional weeks
Group name:Group 3 Type of group
oral lapatinib (1000 mg daily) plus trastuzumab (4 mg / kg iv load followed by 2 mg / kg iv weekly) [lapatinib + trastuzumab] for 6 weeks, followed by iapatinib + trastuzumab plus weekly paclitaxel (80 mg / m ^ iv ) for an additional 12 weeks
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Female sex; • Age 18 years; • Functional status ~ Eastern Cooperative Oncology Group (ECOG) 0-1 (see Appendix 2); • Invasive breast cancer confirmed histologically: - primary tumor greater than 2 cm in diameter, measured by mammography and ultrasound, - any N, - no evidence of metastasis (MO) (supraclavicular ganglion involvement is allowed alone); • Over-expression and / or amplification of HER2 in the invasive component of the primary tumor according to one of the following definitions [Wolff et al 2006] and confirmed by a laboratory certified before the random distribution (see Section 5.2): - 3+ overexpression by IHC (> 30% of invasive tumor cells); - overexpression 2+ or o + (in 3U% or less neoplastic cells) by IHC and in situ Hybridization test (FISH / CISH) demonstrating amplification of the HER2 gene; - Amplification of the HER2 gene by FISH / CISH (> 6 copies of the HER2 gene per nucleus or a FISH index [copies of the HER2 gene to signals on chromosome 17] of> 2.2.) Subjects with negative or equivocal general results ( index of the FISH test of 6 copies of the ErbB2 gene per core or a FISH index of more than 2.2) or 2/3 + overexpression by the IHC obtained in non-certified local laboratories, must be confirmed in one of the certified laboratories before of the random distribution; • Hormone receptor (HR) status: - The status of the estrogen receptor (ER) must be known. • Hematopoietic status: - Absolute neutrophil count> 1.5 x 10 9/1, - Platelet count> 100 x 10 9/1, - Hemoglobin of at least 9 g / dl, • Hepatic status: - Bilirubin 50% measured by echocardiography (ECHO) or controlled multiple-scan study (MUGA), • Serum negative pregnancy test, within 2 weeks (preferably 7 days) prior to randomization (for women with reproductive potential) • Fertile subjects should use effective contraception (barrier method - condoms, diaphragm - also together with spermicidal gel or total abstinence - oral, injectable or implantable hormonal contraceptives are not allowed) • Final informed consent form (FCI) • The subject agrees to deliver samples of the tumor to send to the central laboratory and perform translational studies as part of this protocol
Exclusion criteria
Exclusion criteria: • Administration of pre-treatment for invasive primary breast cancer; • History of another malignant disease. However, participants with a past or current history of squamous and basal carcinoma of completely resected skin or subjects successfully treated for carcinoma in situ of the cervix are eligible; • Diagnosis of inflammatory breast cancer; • Bilateral cancer; • Multifocal cancer; • Known antecedents of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (> / = 180 / l 10), unstable diabetes mellitus, dyspnea at rest or chronic treatment with oxygen; • Illness or concomitant condition that would make the subject unsuitable for participation in the study or any serious medical condition that could interfere with the subject´s safety; • Serious unresolved or unstable adverse events from the previous administration of another investigational product; • Active or uncontrolled infection; • Dementia, altered mental state or any psychiatric condition that could impede the understanding or grant of the FCI; • Malabsorption syndrome, disease that. Significantly affect gastrointestinal function, or resection of the stomach or small intestine. Subjects with ulcerative colitis are also excluded; • Therapy for concurrent neoadjuvant cancer (chemotherapy, radiation therapy, immunotherapy, biological therapy, different from the treatments of the Study); • Concomitant treatment with a drug in research or participation in another therapeutic clinical study; • Reaction of immediate or delayed hypersensitivity known or idiosyncrasy to drugs chemically related to trastuzumab or lapatinib or its excipients; • Pregnant or breastfeeding women; • Concomitant use of inhibitors or inducers of CYP3A4 (see Section 7.2 for the list of prohibited medications).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It will be evaluated by clinical examination and by mammography and mammary ultrasound with two-dimensional measurements, Measure:Tumor response Timepoints:During treatment ; Outcome name:It will be evaluated using the WHO criteria Measure:Objective response Timepoints:During treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Surgical specimens of breast and axillary lymph node resection will be evaluated for pathological tumor response, according to the NSABP guidelines Measure:Complete pathological response Timepoints:After treatment | — |
Contacts
Public ContactMilagros Cardenas
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed