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

August 29, 2016 updated by: iOMEDICO AG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Onkologische Schwerpunktpraxis Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Capecitabine / Bevacizumab
Drug: capecitabine
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
Other Names:
  • Xeloda®
Drug: bevacizumab
15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
Other Names:
  • Avastin®
Drug: bevacizumab
15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
Other Names:
  • Avastin®
EXPERIMENTAL: B
Capecitabine / Bevacizumab / Vinorelbine
Drug: capecitabine
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
Other Names:
  • Xeloda®
Drug: bevacizumab
15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
Other Names:
  • Avastin®
Drug: bevacizumab
15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
Other Names:
  • Avastin®
Drug: vinorelbine
25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.
Other Names:
  • Navirel®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: end of trial
end of trial

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events and serious adverse events
Time Frame: during the whole time of treatment
during the whole time of treatment
Overall Response Rate (ORR = CR +PR)
Time Frame: end of trial
end of trial
Overall Survival (OS)
Time Frame: end of trial
end of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Collaborators

Roche Pharma AG
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien

Investigators

  • Principal Investigator: Susanna Hegewisch-Becker, MD, Onkologische Schwerpunktpraxis Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (ESTIMATE)

March 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-080-2
  • 2008-003779-37 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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