Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

— CARIN  

Official title:

Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868634
• Other study ID #: IOM-080-2
• Secondary ID: 2008-003779-37
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2009
• Last updated: August 29, 2016
• Start date: February 2009
• Est. completion date: October 2015

Study information

• Verified date: August 2016
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• capecitabine
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
• bevacizumab
15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
• capecitabine
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
• bevacizumab
15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
• vinorelbine
25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.

Locations

Country	Name	City	State
Germany	Onkologische Schwerpunktpraxis Eppendorf	Hamburg

Sponsors (4)

Lead Sponsor	Collaborator
iOMEDICO AG	Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien, Roche Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		end of trial	No
Secondary	adverse events and serious adverse events		during the whole time of treatment	Yes
Secondary	Overall Response Rate (ORR = CR +PR)		end of trial	No
Secondary	Overall Survival (OS)		end of trial	No