Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00446030

Purpose

This is a Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens plus Bevacizumab for the Adjuvant Treatment of Subjects with Node Positive or High Risk Node Negative Breast Cancer

Condition	Intervention	Phase
Breast Neoplasms	Drug: Docetaxel	Phase II

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, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Evaluate cardiac safety measured by incidence of Grade 3/4 clinical congestive heart failure, of bevacizumab +-trastuzumab administered with 2 different docetaxel-based combination regimens [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate safety, toxicity & disease-free survival(DFS)& overall survival of subjects treated with bevacizumab +- trastuzumab administered with 2 different docetaxel-based combination regimens [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	March 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stratum 1: Experimental HER2 Negative, TAC + bevacizumab 15 mg/kg IV every 3 weeks for 6 cycles followed by maintenance dose bevacizumab 15 mg/kg IV every 3 weeks for a total of 52 weeks.	Drug: Docetaxel HER2 Negative,TAC + bevacizumab 15 mg/kg IV every 3 weeks for 6 cycles followed by maintenance dose bevacizumab 15 mg/kg IV every 3 weeks for a total of 52 weeks.
Stratum 2: Experimental HER2 Positive, TCH + bevacizumab 15 mg/kg IV every 3 weeks for 6 cycles followed by maintenance dose bevacizumab 15 mg/kg + trastuzumab 6 mg/kg IV every 3 weeks for a total of 52 weeks.	Drug: Docetaxel HER2 Positive, TCH + bevacizumab 15 mg/kg IV every 3 weeks for 6 cycles followed by maintenance dose bevacizumab 15 mg/kg + trastuzumab 6 mg/kg IV every 3 weeks for a total of 52 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women aged 18 to 70 years, inclusive
Histologically proven breast cancer with an interval between definitive breast surgery and study registration of up to 60 days but no sooner than 28 days due to possible wound healing complications. Definitive breast surgery is defined as the most recent surgery done for breast cancer including mastectomy, lumpectomy, re-excision for positive margins and/or axillary lymph node dissection
Definitive surgical treatment must be either mastectomy or lumpectomy with nodal dissection
HER2/neu positive or negative tumors are eligible, tested by FISH.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 - good performance status
Normal cardiovascular function
Normal Liver and blood test
Bilateral, breast cancer is allowed provided one primary tumor meets the staging criteria.
Negative pregnancy test, as assessed by serum beta-hCG, within 14 days prior to day 1 of cycle 1 for all women of childbearing potential.
Women of childbearing potential must be willing to consent to using an effective, non-hormonal method of contraception while receiving study treatment and for at least six (6) months following the last dose of bevacizumab. Also, subjects should be advised not to breast feed for at least six (6) months following the last dose of bevacizumab.

Exclusion Criteria:

Prior systemic anticancer therapy for invasive breast cancer (immunotherapy, hormonotherapy, chemotherapy).
Prior anthracycline therapy, taxoids, or platinum salts for any malignancy.
Prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy.
Pregnant or lactating subjects
Pre-existing motor or sensory neurotoxicity of a severity >Grade 2 by NCI-CTCAE version 3.0
Cardiac disease or risk for same
Other serious illness or medical conditions
Past or current history of neoplasm other than breast carcinoma, except for:
1. Curatively treated non-melanoma skin cancer
2. In situ carcinoma of the cervix
3. Other cancer curatively treated and with no evidence of disease for at least 10 years
4. Ductal carcinoma in-situ (DCIS) of the breast
5. Lobular carcinoma in-situ (LCIS) of the breast

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446030

Locations

United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Vicki Erickson, MSN

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Study Director )
Study ID Numbers:	DOCET_L_00713
Study First Received:	March 8, 2007
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00446030 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Adjuvants, Immunologic
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

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

ClinicalTrials.gov processed this record on May 07, 2009