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

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: Bevacizumab Trastuzumab

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
	Not yet recruiting
LYON, France, 69373
	Not yet recruiting
SAINT HERBLAIN, France, 44805
	Recruiting
CAEN, France, 14076
	Not yet recruiting
NICE, France, 06189
	Not yet recruiting
DIJON, France, 21079
	Not yet recruiting
MONTPELLIER, France, 34298
	Not yet recruiting
SAINT-CLOUD, France, 92210
	Recruiting
PARIS, France, 75249
	Not yet recruiting
TOULOUSE, France, 31052
	Not yet recruiting
VILLEJUIF, France, 94805
	Not yet recruiting
BORDEAUX, France, 33076
	Recruiting
ROUEN, France, 76000
	Not yet recruiting
ANGERS, France, 49033
	Not yet recruiting
RENNES, France, 35062
	Not yet recruiting
STRASBOURG, France, 67065
	Not yet recruiting
CLERMONT-FERRAND, France, 63011
	Not yet recruiting
VANDOEUVRE-LES-NANCY, France, 54511
	Not yet recruiting
REIMS, France, 51056
	Not yet recruiting
STRASBOURG, France, 67098 CEDE
	Not yet recruiting
PARIS, France, 75010
	Not yet recruiting
SAINT BRIEUC, France, 22000
	Not yet recruiting
AVIGNON, France, 84082
	Not yet recruiting
GRENOBLE, France, 38100
	Not yet recruiting
BESANCON, France, 25030
	Not yet recruiting
LE MANS, France, 72000
	Not yet recruiting
BREST, France, 29609
	Not yet recruiting
SAINT-PRIEST-EN-JAREZ, France, 42270
	Recruiting
GRENOBLE, France, 38043
	Not yet recruiting
PERIGUEUX, France, 24000
	Not yet recruiting
BORDEAUX, France, 33030
	Not yet recruiting
MOUGINS, France, 06250
	Not yet recruiting
NIMES, France, 30907
	Not yet recruiting
PERPIGNAN, France, 66000
	Not yet recruiting
TOURS, France, 37044
	Not yet recruiting
ALES, France, 30100
	Not yet recruiting
LILLE, France, 59020
	Not yet recruiting
NANTES, France, 44202
	Not yet recruiting
PARIS, France, 75970

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:	ML21531, 2008-000783-16
Study First Received:	July 16, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00717405
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
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