A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
Collecte de données
Maladies du sein+2
+ Néoplasmes du sein
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 2004
Date à laquelle le premier participant a commencé l'étude.To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Have provided written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice * Be female and at least 18 years of age. Note: must be 19 years of age if the patient is a resident of the state of Alabama * Be ambulatory (outpatient) and have a Karnofsky performance status of more than 70% * Have confirmed breast cancer with locally advanced and/or metastases * Have at least one site with defined tumor * Have met one of the study definitions of primary or nonprimary resistance to an anthracycline-containing therapy Exclusion Criteria: * Pregnant/lactating women * Women of childbearing potential with either a positive or no pregnancy test * Women of childbearing potential unless using a reliable and appropriate contraceptive method (Postmenopausal women must have not had their period for at least 12 months to be considered of non-childbearing potential) * Prior treatment with chemotherapy in the advanced/metastatic setting * HER 2/neu positive status without prior treatment with trastuzumab * Prior treatment with IV bolus 5-FU, continuous 5-FU infusion, capecitabine or other oral fluoropyrimidines * Prior treatment with a taxane if less than 12 months passed from the time of therapy completion to relapse * Mitomycin C or nitrosoureas within 6 weeks preceding treatment start * Organ allografts requiring immunosuppressive therapy * Radiotherapy to the skeleton within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiotherapy * Hormonal therapy within 10 days preceding study treatment start * Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery * Blood transfusions/growth factors to aid hematologic recovery within 2 weeks prior to study treatment start * Participation in any investigational drug study within 4 weeks preceding treatment start * Prior unanticipated severe reaction to fluoropyrimidine therapy * Known hypersensitivity to 5-fluorouracil, taxanes or any of the components of capecitabine * Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues * Evidence of CNS metastases * History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma * Clinically significant (i.e. active) cardiac disease * Abnormal laboratory values * Severe renal impairment * Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease * Lack of physical integrity of the upper GI tract * Life expectancy of less than 3 months * Unwilling/unable to comply with the protocol