Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer

NCT00868634 | Completed Phase 3

• 2 other identifiers: IOM-080-22008-003779-37
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  end of trial

Secondary Outcomes (3)

• adverse events and serious adverse events

  during the whole time of treatment

• Overall Response Rate (ORR = CR +PR)

  end of trial

• Overall Survival (OS)

  end of trial

Study Arms (2)

A

ACTIVE COMPARATOR

Capecitabine / Bevacizumab

Drug: capecitabine; Drug: bevacizumab

B

EXPERIMENTAL

Capecitabine / Bevacizumab / Vinorelbine

Drug: capecitabine; Drug: bevacizumab; Drug: vinorelbine

Interventions

capecitabine DRUG

1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.

Also known as: Xeloda®

A

bevacizumab DRUG

15 mg/kg i.v., day 1 Cycles are repeated every three weeks.

Also known as: Avastin®

A

vinorelbine DRUG

25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.

Also known as: Navirel®

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iOMEDICO AG: lead
• Arbeitsgemeinschaft fur Internistische Onkologie: collaborator
• Arbeitskreis Klinische Studien: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Onkologische Schwerpunktpraxis Eppendorf

Hamburg, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Bevacizumab; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Susanna Hegewisch-Becker, MD

  Onkologische Schwerpunktpraxis Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 25, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2015
• Last Updated: August 31, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)