PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

This study is not yet open for participant recruitment.

Verified by Hoffmann-La Roche, January 2009

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00774241

Purpose

This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: bevacizumab [Avastin] Drug: docetaxel	Phase IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel 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 of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Response rate, median progression free survival, overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Study Completion Date:	November 2011

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 15mg/kg iv every 3 weeks Drug: docetaxel 75mg/m2 every 3 weeks for 18 weeks

Eligibility

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

Criteria

Inclusion Criteria:

male and female patients, >=18 years of age;
stage IV, HER2 negative metastaticbreast cancer;
candidate for taxane-based therapy;
ECOG performance status 0-2.

Exclusion Criteria:

prior chemotherapy for metastatic breast cancer;
concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
suspicion of CNS metastasis;
clinically significant cardiovascular disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774241

Contacts

Contact: Please reference Study ID Number: ML21343	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Mexico

MEXICO CITY, Mexico, 16200

OBREGON, Mexico, 85000

MADERO, Mexico, 89400

SALTILLO, Mexico, 25000

Chihuahua, Mexico, 31328

MEXICO CITY, Mexico, 14140

LEON, Mexico, 37000

PUEBLA, Mexico, 72240

GUADALAJARA, Mexico, 2292

CUERNAVACA, MORELOS, Mexico, 62290

GUADALAJARA, Mexico, 44280

ACAPULCO, Mexico, 39670

MONTERREY, Mexico, 64380

LA PAZ, Mexico, 23040

CUERNAVACA, Mexico, 62270

LEON, Mexico, 37160

MERIDA, Mexico, 97150

MEXICALI, Mexico, 21100

MONTERREY, Mexico, 64020

CHIAPAS, Mexico, 84300

CHIAPAS, Mexico, 49000

TORREON, Mexico, 27200

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:	ML21343
Study First Received:	October 16, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00774241
Health Authority:	Mexico:Ministry of Health (COFEPRIS)

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms
Bevacizumab
Breast Diseases

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