RANDOMIZED, MULTICENTER, OPEN, PHASE III,STUDY OF LAPATINIB, TRASTUZUMAB AND ITS COMBINATION IN NEOADYUVANCIA MORE PACLITAXEL IN WOMEN WITH PRIMARY BREAST CANCER HER2 / ERBB2 POSITIVE

OVARTIS BIOSCIENSES PERU S.A.,0 sites38 target enrollmentNovember 21, 2007

Conditions-C509 Breast, unspecified Breast, unspecified C509

Overview

Phase: 未知
Intervention: Not specified
Conditions: -C509 Breast, unspecified
Sponsor: OVARTIS BIOSCIENSES PERU S.A.,
Enrollment: 38
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 21, 2007

End Date

September 15, 2019

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

OVARTIS BIOSCIENSES PERU S.A.,

Eligibility 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 \<2\.2, \<6\.0 copies of the HER2 gene per nucleus) and O, 1\+, 2\+ or 3\+ staining scores (in 30% or less of the neoplastic cells) per IHC they are not eligible for participation in the Study.
•Misleading local results from non\-certified laboratories can be sent for a final determination in a certified laboratory.
•The status of ErbB2 should be studied in certified local or regional laboratories prior to randomisation. If a local FISH test is performed in non\-certified laboratories, the Path´Vysion (Vysis) or INFORM HER2 / neu (Inc. Window) test should be used, but they will also need confirmation of the results by a certified laboratory. IHC over\-expression scores obtained locally will also require confirmation from a certified laboratory to be considered as entry criteria. Subjects with negative FISH / CISH local tests (test score \<1\.8, \<4\.0 copies of the ErbB2 gene per nucleus) or with IHC scores O and 1\+ are not eligible for participation in the Study. Positive local FISH tests (\> 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 • Kidney status: \- Creatinine • Cardiovascular: \- baseline LVEF\> 50% measured by echocardiography (ECHO) or controlled multiple\-scan study (MUGA),

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;