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Clinical Trials/EUCTR2008-003779-37-DE
EUCTR2008-003779-37-DE
Active, not recruiting
Not Applicable

Capecitabine and bevacizumab ± vinorelbine as 1st line treatment in HER2/neu-negative metastatic or locally advanced inoperable breast cancer patients - CARIN-Trial

iOMEDICO AG0 sitesOctober 30, 2008
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DrugsXelodaNavirelAvastin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
iOMEDICO AG
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 30, 2008
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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