A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, April 2009

First Received: July 16, 2008 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00717405

Purpose

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: trastuzumab [Herceptin] Drug: bevacizumab [Avastin] Drug: Standard chemotherapy	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab 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 Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-Positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Rate of pathological complete response [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-free survival; recurrence free interval; overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs; cardiac safety [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2013

Arms	Assigned Interventions
1: Experimental	Drug: trastuzumab [Herceptin] 8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8. Drug: bevacizumab [Avastin] 15mg/kg iv 3 weekly in cycles 1-8 Drug: Standard chemotherapy As prescribed

Eligibility

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

Criteria

Inclusion Criteria:

adult females, >=18 years of age;
inflammatory breast cancer;
HER2-positive tumors;
performance status 0-2.

Exclusion Criteria:

metastases;
previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;
clinically significant cardiovascular disease, or history of thrombotic disorders.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717405

Contacts

Contact: Please reference Study ID Number: ML21531	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

France
	Recruiting
MARSEILLE, France, 13273
	Recruiting
LYON, France, 69373
	Recruiting
SAINT HERBLAIN, France, 44805
	Recruiting
CAEN, France, 14076
	Recruiting
NICE, France, 06189
	Recruiting
DIJON, France, 21000
	Recruiting
MONTPELLIER, France, 34298
	Recruiting
SAINT-CLOUD, France, 92210
	Recruiting
PARIS, France, 75249
	Recruiting
TOULOUSE, France, 31052
	Recruiting
VILLEJUIF, France, 94805
	Not yet recruiting
BORDEAUX, France, 33076
	Recruiting
ROUEN, France, 76000
	Not yet recruiting
ANGERS, France, 49033
	Recruiting
RENNES, France, 35062
	Recruiting
STRASBOURG, France, 67065
	Recruiting
CLERMONT-FERRAND, France, 63011
	Recruiting
STRASBOURG, France, 67098
	Recruiting
REIMS, France, 51056
	Recruiting
PARIS, France, 75970
	Recruiting
PARIS, France, 75010
	Recruiting
SAINT BRIEUC, France, 22000
	Not yet recruiting
AVIGNON, France, 84082
	Not yet recruiting
GRENOBLE, France, 38100
	Recruiting
BESANCON, France, 25030
	Not yet recruiting
LE MANS, France, 72000
	Recruiting
BREST, France, 29609
	Recruiting
SAINT-PRIEST-EN-JAREZ, France, 42270
	Recruiting
GRENOBLE, France, 38043
	Recruiting
BORDEAUX, France, 33030
	Not yet recruiting
TOURS, France, 37044
	Recruiting
LILLE, France, 59020
	Recruiting
NANTES, France, 44202
	Recruiting
VANDOEUVRE-LES-NANCY, France, 54511

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:	ML21531, 2008-000783-16
Study First Received:	July 16, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00717405 History of Changes
Health Authority:	France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms

Bevacizumab
Angiogenesis Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Trastuzumab
Growth Inhibitors
Angiogenesis Modulating Agents
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009