carcinoma breast MedDRA version: M15 Level: LLT Classification code 10007305
Conditions
Interventions
Product Name: Glivec Filmtabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Imatinib Mesilat
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Women 2.Patients >= 18 years of age. 3.Histologically documented diagnosis of invasive breast cancer, which is locally advanced or metastatic 4.Previous anthracycline containing chemotherapy 5.Immunohistochemical documentation of c-kit (CD117) and /or PDGF-receptor expression by tumor 6.Preferably tumor samples should be taken within 6 weeks of study entry, at last primary tumor tissue have to be available for expression analysis 7.At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria, see Appendix 2), or other response assessment criteria, as appropriate. 8.Performance status 0,1 or 2 (ECOG) (see Section 7.1) 9.Adequate end organ function, defined as the following: total bilirubin 1.5 x 109/L, platelets > 100 x 109/L. 10.Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential.Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. 11.Written, voluntary informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing. 2.Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed. 3.Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) 4.Female patients who are pregnant or breast-feeding. 5.Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). 6.Patient has a known brain metastasis. 7.Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). 8.Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. 9.Patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing. 10.Patient previously received radiotherapy to ? 25 % of the bone marrow 11.Patient had a major surgery within 2 weeks prior to study entry. 12.Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. 13.Patient received either Vinorelbine or Imatinib in previous treatment regimens 14.Breast tumor does not show expression for c-kit or PDGF-receptor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of Glivec in combination with Vinorelbine in patients with progressive or metastatic breast cancer after previous anthracycline chemotherapy. ;Secondary Objective: •Clinical activity of the combination as Best overall reponse (at least PR, according to SWOG) and Time to disease progression (TTP). •Qualitiy of Life (acc. to the EORTC QLQ-C30 and BR23 questionnaire) •Biological activity of the combination by pharmacogenetic measurements as described in the pharmacogenetic section ;Primary end point(s): Safety and tolerability (total toxicity, incidence of hematological toxicity/ grade 3 and 4 and of non-hematological toxicity /grade 3 and 4) for this novel drug combination. Other endpoints are clinical activity of the combination as Clinical Response Rate (CRR) and Time to disease progression (TTP) and the biological activity of the combination by pharmacogenetic measurements as described in the pharmacogenetic section. Expression of specific tyrosin kinase receptors (c-kit and PDGF-receptor) will be correlated with treatment response (where feasible). Biological reactions in tumor and non-tumor tissue during therapy will be investigated clinically and after biopsies by further tissue processing. Another secondary endpoint is the quality of life (acc. to the EORTC QLQ-C30 and BR23 questionnaire) which will be examined in the whole course of treatment. | — |
Countries
Germany
Outcome results
None listed