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
  Purpose

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 2

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 ]

Estimated Enrollment: 600
Study Start Date: February 2009
Estimated Study Completion Date: December 2015
Estimated 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®

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868634

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

No publications provided

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00868634     History of Changes
Other Study ID Numbers: IOM-080-2, EudraCT-Nr.: 2008-003779-37
Study First Received: March 23, 2009
Last Updated: March 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 02, 2014