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Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Two-arm, Double-blind, Multi-center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer

NCT00615940•Heidelberg Pharma AG

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+7 more criteria

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.
+5 more criteria

Locations (20)

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

Key Dates

Start Date

July 1, 2008

Primary Completion Date

December 1, 2011

Completion Date

April 1, 2012

Last Updated

February 28, 2014

Enrollment

132

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

WX-671

DRUG

placebo

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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