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Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer (CARIN)
This study is currently recruiting participants.
Verified by iOMEDICO AG, March 2009
First Received: March 23, 2009   Last Updated: March 24, 2009   History of Changes
Sponsors and Collaborators: iOMEDICO AG
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis klinische Studien (AKS)
Hoffmann-La Roche
Information provided by: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00868634
  Purpose

The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine vs. the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 400 patients, 200 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 II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Vinorelbine Vinorelbine tartrate Capecitabine Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients

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 ]

Estimated Enrollment: 400
Study Start Date: February 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator Drug: capecitabine
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
Drug: bevacizumab
15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
B: Experimental Drug: capecitabine
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
Drug: bevacizumab
15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
Drug: vinorelbine
25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.

  Eligibility

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

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 cen-tral 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 coagulopa-thy 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 intraabdominal 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 medi-cation. Concurrent participation in another clinical trial. Prior participa-tion is allowed when the last study medication was applied more than 4 weeks prior to randomization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868634

Contacts
Contact: Annette Hipper, PhD ++ 49 761-15242-0 info@iomedico.com

Locations
Germany
Onkologische Schwerpunktpraxis Eppendorf Recruiting
Hamburg, Germany
Principal Investigator: Hegwisch-Becker, MD            
Sponsors and Collaborators
iOMEDICO AG
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis klinische Studien (AKS)
Hoffmann-La Roche
Investigators
Principal Investigator: Susanna Hegewisch-Becker, MD Onkologische Schwerpunktpraxis Eppendorf
  More Information

No publications provided

Responsible Party: iOMEDICO AG ( Annette Hipper, PhD )
Study ID Numbers: IOM-080-2, EudraCT-Nr.: 2008-003779-37
Study First Received: March 23, 2009
Last Updated: March 24, 2009
ClinicalTrials.gov Identifier: NCT00868634     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Antimetabolites
Capecitabine
Vinorelbine
Skin Diseases
Breast Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vinorelbine
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009