A Study of Avastin (Bevacizumab) in Combination With Taxane-Based Chemotherapy as First Line Treatment in Patients With HER2 Negative Breast Cancer.

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, April 2009

First Received: February 17, 2009 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00846027

Purpose

This single arm study will assess the efficacy and safety of first line treatment with Avastin in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER2 negative breast cancer. Eligible patients will receive Avastin 10mg/kg iv, paclitaxel 150mg/m2 and gemcitabine 200mg/m2 iv on days 1 and 15 of each 4 week treatment cycle. 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: paclitaxel Drug: gemcitabine	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Gemcitabine Gemcitabine hydrochloride 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 ASSESS THE EFFECT OF FIRST LINE TREATMENT WITH AVASTIN IN COMBINATION WITH PACLITAXEL AND GEMCITABINE IN PROGRESSION-FREE SURVIVAL IN PATIENTS WITH HER-2 NEGATIVE BREAST CANCER

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival [ Time Frame: Event driven; tumor assessments every 3 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best overall survival; overall response; duration of response; [ Time Frame: Event driven; tumor assessments every 3 cycles ] [ Designated as safety issue: No ]
Adverse events; laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2009
Estimated Study Completion Date:	November 2011

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 10mg/kg iv on days 1 and 15 of each 4 week cycle Drug: paclitaxel 150mg/m2 iv on days 1 and 15 of each 4 week cycle Drug: gemcitabine 200mg/m2 iv on days 1 and 15 of each 4 week cycle

Eligibility

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

Criteria

Inclusion Criteria:

female patients, >=18 years of age;
breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only;
HER2-negative disease;
candidates for chemotherapy;
ECOG PS of <=2;

Exclusion Criteria:

previous chemotherapy for metastatic or locally advanced breast cancer;
previous radiotherapy for treatment of metastatic breast cancer;
any prior adjuvant treatment with anthracyclines completed <6 months prior to enrolment;
chronic daily treatment with corticosteroids (>=10mg/day) aspirin (>325mg/day) or clopidogrel (>75mg/day);

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846027

Contacts

Contact: Please reference Study ID Number: ML21999	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Spain
	Not yet recruiting
CÁDIZ, Spain, 11009
	Recruiting
SEVILLA, Spain, 41014
	Recruiting
SEVILLA, Spain, 41071
	Not yet recruiting
HUELVA, Spain, 21005
	Recruiting
CÓRDOBA, Spain, 14004
	Recruiting
JAEN, Spain, 23007
	Recruiting
GRANADA, Spain, 18003
	Recruiting
VIGO, Spain, 36214
	Not yet recruiting
LUGO, Spain, 27004
	Recruiting
SAGUNTO, Spain, 46520
	Recruiting
MADRID, Spain, 28041
	Not yet recruiting
MURCIA, Spain, 30008
	Not yet recruiting
Alcorcon, Spain, 28922
	Not yet recruiting
ZARAGOZA, Spain, 50009
	Not yet recruiting
GRANADA, Spain, 18014
	Not yet recruiting
ELDA, Spain, 03600
	Recruiting
MANRESA, Spain, 08243
	Recruiting
LAS PALMAS DE GRAN CANARIA, Spain, 35016
	Recruiting
BURGOS, Spain, 09005
	Recruiting
BARCELONA, Spain, 08022
	Not yet recruiting
BARCELONA, Spain, 08907

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21999, 2008-003657-32
Study First Received:	February 17, 2009
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00846027 History of Changes
Health Authority:	Spain:Agencia Espanola del Medicamento

Study placed in the following topic categories:

Antimetabolites
Skin Diseases
Immunologic Factors
Disease Progression
Breast Neoplasms
Antimitotic Agents
Bevacizumab
Angiogenesis Inhibitors
Antiviral Agents

Immunosuppressive Agents
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Gemcitabine
Antineoplastic Agents, Phytogenic
Taxane
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Gemcitabine
Breast Diseases
Skin Diseases

Growth Substances
Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009