HER-2/neu negative metastatic or locally advanced inoperable breast cancer MedDRA version: 17.1 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Xeloda
Product Name: Capecitabin
Product Code: Ro 09-1978
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Capecitabin
CAS Number: 154361-50-9
Current Sponsor code: Ro 09-1978
Sponsors
iOMEDICO AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically confirmed HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy -effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug - Adequate hepatic and renal function - Adequate hematologic function - Written informed consent 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: - contra-indication against Capecitabine, Bevacizumab or Vinorelbin - Previous chemotherapy or previous bevacizumab-therapy for metastatic or locally recurrent breast cancer -Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix. - Pregnant or lactating women - Participation in other clinical trials within 4 weeks prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify the superiority of the combination capecitabine, bevacizumab and vinorelbin compared to the combination of capecitabine and bevacizumab. Primary endpoint: Progression free survival;Secondary Objective: Overall Response rate (ORR = CR + PR) Overall survival (OS) Saftey Translational research (protein and gene expression in tumor tissue) Health Outcome Project (HOP);Primary end point(s): Progression of disease.;Timepoint(s) of evaluation of this end point: Every 9 weeks or if clinically indicated | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall response rate (ORR) Overall survival (OS) Safety Epigenetic Profiling Health outcome (HOP);Timepoint(s) of evaluation of this end point: ORR: Every 9 weeks or if clinically indicated OS: Date of death Safety: continuously Epigenetic profiling: Day 1 of cycles 2,4,7,10,13,16 and progression of disease (PD) HOP: Every 9 weeks until PD afterwards every 3 months | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
iOMEDICO AG
Outcome results
None listed