Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT00615940

Run by

Heidelberg Pharma AG

People needed

132

Starts

2008-07-01

Expected to finish

2012-04-01

Last updated by the study team

2014-02-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Montefiore Medical Center Weiler Division Department — New York, New York, United States
• Universitys Hospital Case Medical Center — Cleveland, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• AZ Klina, Oncology Department — Brasschaat, Belgium
• Institut Jules Bordet Oncologie Médicale — Brussels, Belgium
• CHU de Liège, Domaine Universitaire de Sart-Tilman, Oncology Department — Liège, Belgium
• Irmandade de Misericórdia da Santa Casa de Porto Alegre — Porto Alegre, Brazil
• Instituto Nacional do Câncer - INCA — Rio de Janeiro, Brazil
• Instituto Brasileiro de Controle do Câncer - IBCC — São Paulo, Brazil
• Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter — Augsburg, Germany
• Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln — Cologne, Germany
• Universitätsklinikum Essen, Innere Klinik und Poliklinik (Tumorforschung) — Essen, Germany
• Uniklinik Frankfurt, Zentrum der Frauenheilkunde und Geburtshilfe — Frankfurt am Main, Germany
• Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg, Poliklinik Gynäkologie — Halle, Germany
• Bethesda KH — Mönchengladbach, Germany
• Department of Obstetrics and Gynecology, Technical University — Munich, Germany
• Davidof Center, Rabin Medical Center, Department of Oncology — Petah Tikva, Israel
• Kaplan Medical Center, Department of Oncolocy — Rehovot, Israel
• Sheba Medical Center, Department of Oncology — Tel Litwinsky, Israel
• Assaf Harofeh medical center, Department of Oncology — Ẕerifin, Israel

Full record on ClinicalTrials.gov

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