Metastatic breast cancer
Conditions
Interventions
Trade Name: Xeloda 150 mg
Product Code: RO 09-1978
Pharmaceutical Form: Tablet
Trade Name: Xeloda 500 mg
Product Code: RO 09-1978
Pharmaceutical Form: Tablet
Trade Name: Taxotere 20 mg
Product Nam
Sponsors
F.Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Give 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 2. Be female and > 18 years of age. 3. Be ambulatory and have a Karnofsky performance status of > 70% 4. Have histologically or cytologically confirmed breast cancer with locally advanced and/or metastatic disease 5. Have at least one target lesion according to the RECIST criteria (see Appendix 4 of the protocol for details of RECIST). Target lesions measured solely by PET scan will be acceptable if = 2cm in longest diameter. 6. Have met one of the study definitions of primary or non-primary resistance to an anthracycline-containing therapy, as modified from Piccart (1995) [39]: Primary resistance: Patients progressing on anthracycline-based chemotherapy, without experiencing any transient improvement, Non-Primary resistance: Patients whose disease remains stable after administration of a minimum of four cycles of anthracycline-based chemotherapy, Patients experiencing a brief objective response to anthracycline-based chemotherapy with subsequent progression while on the same therapy or within 12 months after last dose, Patients relapsing within 2 years of the completion of an anthracycline-based neoadjuvant or adjuvant chemotherapy regimen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Women of childbearing potential with either a positive or no pregnancy test at baseline 3. Women of childbearing potential unless using a reliable and appropriate contraceptive method. 4. Chemotherapy within four weeks preceding treatment start 5. Prior treatment with more than two regimens of chemotherapy in the advanced/metastatic (non-adjuvant) setting 6. Prior treatment with continuous (>24h) 5-FU infusion, capecitabine or other oral fluoropyrimidines such as eniluracil/5-FU, uracil/tegafur, S1 or emitefur 7. Prior treatment with a docetaxel-containing regimen in the advanced/metastatic disease setting 8. Mitomycin C or Nitrosoureas within 6 weeks preceding treatment start, 9.Organ allografts (excluding bone marrow auto- or allografts) 10. Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy 11. Hormonal therapy within 10 days preceding study treatment start 12. Incomplete recovery from the effects of major surgery 13. Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start 14. Participation in any investigational drug study within 4 weeks preceding treatment start 15. Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) 16. Known hypersensitivity to 5-fluorouracil, any of the components of capecitabine or docetaxel 17. Severe renal impairment (creatinine clearance 1.5 x Upper Limit of Normal (ULN) • serum bilirubin > ULN • ALAT(SGPT) and/or ASAT(SGOT) > 5 x ULN (1.5 x if alkaline phosphatase is concomitantly elevated = 2.5 x ULN) • alkaline phosphatase > 5 x ULN (except when bone metastases are present in the absence of any liver disorders) • serum calcium >11.5 mg/dL 22. Serious uncontrolled intercurrent infections 23. Lack of physical integrity of the upper gastrointestinal tract or those who have clinically significant malabsorption syndrome 25. Life expectancy of less than 3 months 27. Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the combination of capecitabine (825 mg/m2 twice daily d1-14) and docetaxel (75 mg/m2) d1 Q3W is at least equivalent to the combination of capecitabine (1250 mg/m2 twice daily d1-14 ) and docetaxel (75 mg/m2) d1 Q3W in terms of time to disease progression or death due to any cause.;Secondary Objective: - To evaluate and compare the safety profile of each of the two regimens of capecitabine plus docetaxel combination therapy using the NCI CTC (Version 3.0). - To evaluate in each study arm overall response rate (complete and partial responders according to RECIST criteria), time to response and duration of overall response (in responding patients), time to treatment failure, and overall survival. - To investigate the effect of long term co-administration of capecitabine and docetaxel on the pharmacokinetics of capecitabine and docetaxel. - To evaluate the effect of age on efficacy, toxicity, dose, and pharmacokinetics;Primary end point(s): Time to tumor progression or death (TTP) | — |
Countries
Czech Republic
Outcome results
None listed