Open-label trial of imatinib mesylate (Glivec, formerly known as STI571) in combination with vinorelbine (Navelbine) for patients with advanced breast carcinoma - ICO

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 30

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 ULN, SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, ANC > 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

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