combination of oral wx-671 plus capecitabine vs. capecitabine monotherapy in first-line her2-negative metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this randomized, double-blind, placebo controlled phase ii trial is studying how well capecitabine works when given in combination with wx-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * females aged ≥ 18 years * patients appropriate for palliative first-line, mono chemotherapy with capecitabine * histological or cytological confirmed, non-inflammatory metastatic breast cancer * availability of paraffin-embedded tumor tissue from the primary resection or biopsy of a metastatic lesion. * her2-negative breast cancer * complete staging within 2 weeks prior to randomization (4 weeks for bone scan). * radiologically confirmed disease * ecog performance status of ≤ 2 * ability to understand and willingness to voluntarily sign and date a written informed consent form before screening * negative pregnancy test (urine or serum) within 3 days before first study drug for women of childbearing potential. use of effective contraception during the study and for 3 months after stopping study drug treatment. * normal organ and marrow function as defined by laboratory parameters (obtained within the screening period) within the following limits: * neutrophils \>= 1.5 x 109/l; * platelets \>= 100 x 109/l; * hemoglobin \>= 9.0 g/dl (5.6 mmol/l). * total bilirubin \<= 1.5 x upper limit of normal (uln); * aspartate aminotransferase (ast)/alt \<= 2.5 x uln (\< 5.0 x uln for patients with liver metastases); * serum creatinine \ 45 ml/min according to cockroft and gault formula). exclusion criteria: * endocrine therapy completed within 2 weeks before the start of treatment (i.e. previous hormone therapy is allowed provided that there is a washout period of 2 weeks). * prior chemotherapy or biologic therapy for metastatic disease. * major surgery within 4 weeks prior to the start of treatment. * other anti-cancer treatment (e.g. hormones) within 2 weeks before the start of treatment. * treatment within 12 months with adjuvant 5-fu containing chemotherapy (regarded as indicating 5-fu resistance) and/or prior capecitabine therapy. * radiation therapy. palliative radiation of stable, non-target lesions more than 2 weeks before the start of treatment is allowed, provided patients have recovered from the radiation side-effects. * history of or radiological evidence of brain metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement. * active seizure disorder or history of cerebrovascular accident (cva) or transient ischemic (ti) attack within the past 12 months. * history of other malignancy within the last 3 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ. * active cardiac disease e.g. unstable angina, congestive heart failure, myocardial infarction (mi) within the preceding 6 months. * any medical condition prohibiting standard imaging procedures * pregnant or breast-feeding. * any unrelated illness, e.g. active infection requiring parenteral antibiotics, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect patients' study participation. * any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of either study drug. * known hepatitis b/c or hiv (human immunodeficiency virus) infection.

Keywords: her2negative