Metastatic Breast Cancer
Conditions
Keywords
HER2negative
Brief 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.
Interventions
DRUGWX-671
capsules taken per os once daily until progression or toxicity
DRUGplacebo
capsule taken per os once daily until progression or toxicity
Sponsors
U.S. Army Medical Research and Development Command
Heidelberg Pharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 \<= 2 x ULN, or calculated creatinine clearance \>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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy in terms of progression-free survival (PFS) | disease staging with CT/MRI/bone scans at regular intervals |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are objective response rate (ORR), overall survival, safety and pharmacokinetics. | 2 years |
Countries
Belgium, Brazil, Germany, Israel, United States
Outcome results
None listed