Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer (CARIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
Roche Pharma AG
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00868634
First received: March 23, 2009
Last updated: March 11, 2014
Last verified: March 2014

March 23, 2009
March 11, 2014
February 2009
March 2014   (final data collection date for primary outcome measure)
Progression free survival (PFS) [ Time Frame: end of trial ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00868634 on ClinicalTrials.gov Archive Site
  • adverse events and serious adverse events [ Time Frame: during the whole time of treatment ] [ Designated as safety issue: Yes ]
  • Overall Response Rate (ORR = CR +PR) [ Time Frame: end of trial ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: end of trial ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer
Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients

The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: capecitabine
    1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
    Other Name: Xeloda®
  • Drug: bevacizumab
    15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
    Other Name: Avastin®
  • Drug: bevacizumab
    15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
    Other Name: Avastin®
  • Drug: vinorelbine
    25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.
    Other Name: Navirel®
  • Active Comparator: A
    Capecitabine / Bevacizumab
    Interventions:
    • Drug: capecitabine
    • Drug: bevacizumab
  • Experimental: B
    Capecitabine / Bevacizumab / Vinorelbine
    Interventions:
    • Drug: capecitabine
    • Drug: bevacizumab
    • Drug: vinorelbine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
December 2015
March 2014   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Written informed consent.
  • Able to comply with the protocol.
  • ECOG Performance status 0 - 2.
  • Life expectancy more than 12 weeks.
  • Known ER / PR status.
  • Confirmed HER2/neu-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy.
  • Previous (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was applied more than 6 months prior to randomization.
  • Previous adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that no more than 30% of marrow-bearing bone was irradiated.
  • No signs and symptoms of CHF.
  • Adequate hepatic and renal function values.
  • Adequate hematologic function values.

Key Exclusion Criteria:

  • Pregnant or lactating females.
  • Previous chemotherapy for metastatic or locally recurrent breast cancer.
  • Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain)
  • Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
  • Major surgical procedure, open biopsy or significant traumatic in-jury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.
  • History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
  • Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg). Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.
  • Non-healing wound, active peptic ulcer or bone fracture.
  • History of abdominal fistula, or any grade 4 nongastrointestinal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months of randomization.
  • Active infection requiring i.v. antibiotics at randomization.
  • Clinically significant malabsorption syndrome or inability to take oral medication.
  • Known hypersensitivity to any of the study drugs or excipients.
  • Concurrent treatment with any drug interfering with study medication. Concurrent participation in another clinical trial. Prior participation is allowed when the last study medication was applied more than 4 weeks prior to randomization.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00868634
IOM-080-2, EudraCT-Nr.: 2008-003779-37
Not Provided
iOMEDICO AG
iOMEDICO AG
  • Arbeitsgemeinschaft fur Internistische Onkologie
  • Arbeitskreis Klinische Studien
  • Roche Pharma AG
Principal Investigator: Susanna Hegewisch-Becker, MD Onkologische Schwerpunktpraxis Eppendorf
iOMEDICO AG
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP