Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study

NCT00378638 | Unknown Phase 2

• 1 other identifier: AVF3359s
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research focuses on women with breast cancer whose disease has not significantly progressed, but who have 5 or more lymph nodes involved. In this study subjects will receive bevacizumab, a drug which is FDA approved for colon cancer but not for breast cancer, in combination with a regimen of approved chemotherapy drugs known as "dose dense chemotherapy." The study will observe the effectiveness and tolerability of this regimen.

Conditions

Breast Cancer

Keywords

lymph; node; positive; breast; cancer; metastases; angiogenesis; bevacizumab; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment failure, 2 and 5 year Disease Free Survival.

Secondary Outcomes (4)

• 2 and 5 Year Disease Free Survival.

• Overall survival.

• Circulating Tumor Cells and Circulating Endothelial Progenitor Cells assays results and their association with clinical outcomes.

• Toxicities and adverse events.

Interventions

bevacizumab combined with dose dense chemotherapy DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk lymph node positive breast cancer defined as 5 or more involved axillary lymph nodes
• Must have undergone surgical local therapy (modified radical mastectomy or breast conserving surgery).
• Negative tumor margins for invasive cancer
• No evidence of distant metastasis
• Normal cardiac ejection fraction
• Adequate organ function defined as:
• ANC \> 1200/mm3 Platelet count \> 100,000/mm Serum creatinine \< 2.0 mg/dl Serum bilirubin \< 1.5 x ULN
• Performance status 0-1
• Age 18 years or older
• No prior chemotherapy, hormonal therapy or radiation therapy for treatment of the primary breast cancer
• Bilateral synchronous breast cancer is allowed if other criteria are met.
• Patients may be ER/PR+ and receive treatment with hormonal therapy (tamoxifen or aromatase inhibitors)
• Use of effective means of contraception (men and women) in subjects of child-bearing potential
• Signed informed consent

You may not qualify if:

• Evidence of distant metastases
• Inflammatory Breast Cancer
• Prior use of any chemotherapy or hormonal therapy for breast cancer
• Patients with her 2 neu positive tumors
• History of other malignancies within the last 5 years. Prior history of carcinoma in situ of the cervix, melanoma in situ and basal cell carcinoma of the skin is allowed within the last 5 years.
• Prior therapy with anthracyclines for any malignancy
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
• Blood pressure of equal to or higher than 150/100
• Unstable angina
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction within 6 months
• History of stroke within 6 months
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Presence of central nervous system or brain metastases

Sponsors & Collaborators

• Chap, Linnea I., M.D.: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Premiere Oncology

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Linnea I. Chap, MD

  Premiere Oncology, A Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linnea I. Chap, MD

CONTACT

(310) 633-8400; lchap@premiereoncology.com

Marilyn Mulay, MSN

CONTACT

(310) 633-8400; mmulay@premiereoncology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 18, 2006
• First Posted: September 20, 2006
• Study Start: June 1, 2006
• Study Completion: October 1, 2008
• Last Updated: October 24, 2007

Record last verified: 2007-10

Locations

US (1)