A Study of Avastin (Bevacizumab) in Combination With Neoadjuvant Treatment Regimens in Patients With Primary HER2 Negative Breast Cancer - Full Text View

Sponsors and Collaborators:	Hoffmann-La Roche The Norwegian Radium Hospital
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00773695

Purpose

This 2 arm study will evaluate the effect of Avastin, in combination with chemotherapy or endocrine therapy, as preoperative treatment in patients with HER2 negative breast cancer. Patients will be randomized to recive either chemotherapy (FEC100 for 4 x 3weekly cycles or endocrine therapy (an aromatase inhibitor daily for 24 weeks)with or without Avastin (15mg/kg iv every 3 weeks).The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: bevacizumab [Avastin] Drug: Placebo Drug: Standard chemotherapy or endocrine therapy	Phase II

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, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Responses in Patients With Large Primary HER2 Negat

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

MRI determinants of pathological complete response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Molecular changes in protein kinase, mRNA/miRNA and protein expression; SNP profiles predicting treatment response; treatment-induced changes in tumor cells. [ Time Frame: Thoughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2010

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 15mg/kg iv every 3 weeks Drug: Standard chemotherapy or endocrine therapy As prescribed
2: Placebo Comparator	Drug: Placebo iv every 3 weeks Drug: Standard chemotherapy or endocrine therapy As prescribed

Eligibility

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

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
HER2-negative breast cancer, >=2.5cm in size;
ECOG/WHOperformance status <=2;
normal baseline cardiac function (LVEF).

Exclusion Criteria:

stage IV (metastatic) disease;
previous treatment for localized breast cancer < 24 months from diagnosis of present breast cancer;
other previous or current cancer except for basal cell cancer or in situ cervical cancer;
current or recent use of aspirin (>325mg/day);
clinically significant cardiovascular disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773695

Contacts

Contact: Please reference Study ID Number: ML21744	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Norway
	Recruiting
Oslo, Norway, 0310
	Not yet recruiting
OSLO, Norway, 0407

Sponsors and Collaborators

Hoffmann-La Roche

The Norwegian Radium Hospital

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:	ML21744
Study First Received:	October 15, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00773695
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Bevacizumab
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Growth Substances

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

ClinicalTrials.gov processed this record on January 14, 2009