A Study of Circulating Endothelial Cell as Marker for Avastin (Bevacizumab) in Combination With Docetaxel Plus Xeloda (Capecitabine) as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer

NCT00845910 | Terminated Phase 2

• 1 other identifier: ML21870
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

Brief Summary

This single arm study will evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3 week cycle, plus Avastin 7.5 mg/kg iv on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Every 12 weeks

Secondary Outcomes (2)

• Time to disease progression

  Event driven

• Serious adverse events

  At planned visits, till disease progression

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: docetaxel

Interventions

bevacizumab [Avastin] DRUG

7.5mg/kg iv on day 1 of every 3 week cycle

1

capecitabine [Xeloda] DRUG

900mg/m2 po on days 1-14 of every 3 week cycle

1

docetaxel DRUG

60mg/m2 iv on day 1 of every 3 week cycle

1

Eligibility Criteria

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

You may qualify if:

• female patients, 18-65 years of age;
• locally recurrent and metastatic breast cancer;
• measurable or evaluable disease;
• ECOG performance status of 0-2;
• LVEF \>=50% without clinical symptoms or signs of heart failure.

You may not qualify if:

• unknown HER2 status, or known HER2-positive status;
• prior chemotherapy for locally recurrent or metastatic disease;
• prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment;
• clinical or radiological evidence of CNS metastases;
• clinically significant cardiovascular disease.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

Taichung, 404, Taiwan

Location

Unknown Facility

Taichung, 407, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

TW (4)