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

This study has been completed.
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
Roche Pharma AG
Information provided by (Responsible Party):
iOMEDICO AG Identifier:
First received: March 23, 2009
Last updated: February 23, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: capecitabine
Drug: bevacizumab
Drug: vinorelbine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients

Resource links provided by NLM:

Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: end of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 600
Study Start Date: February 2009
Study Completion Date: October 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Capecitabine / Bevacizumab
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®
Experimental: B
Capecitabine / Bevacizumab / Vinorelbine
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: vinorelbine
25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.
Other Name: Navirel®


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00868634

Onkologische Schwerpunktpraxis Eppendorf
Hamburg, Germany
Sponsors and Collaborators
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
Roche Pharma AG
Principal Investigator: Susanna Hegewisch-Becker, MD Onkologische Schwerpunktpraxis Eppendorf
  More Information

Responsible Party: iOMEDICO AG Identifier: NCT00868634     History of Changes
Other Study ID Numbers: IOM-080-2  2008-003779-37 
Study First Received: March 23, 2009
Last Updated: February 23, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016