A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00448591

Purpose

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: bevacizumab [Avastin] Drug: Taxane-based chemotherapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-Based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Incidence of AEs, and SAEs related to Avastin [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of survival, time to disease progression [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Estimated Enrollment:	2300
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2011

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle Drug: Taxane-based chemotherapy As prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients, >=18 years of age;
HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
candidates for chemotherapy.

Exclusion Criteria:

previous chemotherapy for metastatic or locally recurrent breast cancer;
concomitant hormonal therapy for metastatic or locally recurrent disease;
concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
previous radiotherapy for treatment of metastatic disease;
evidence of CNS metastases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448591

Contacts

Contact: Please reference Study ID Number: MO19391	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 468 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MO19391
Study First Received:	March 16, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00448591
Health Authority:	Australia: Joint Human Research Ethics Committee

Study placed in the following topic categories:

Skin Diseases
Disease Progression
Breast Neoplasms
Bevacizumab

Taxane
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009