Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Heidelberg Pharma AG
With
U.S. Army Medical Research and Development Command
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
Clareo Health | Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
