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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Chap, Linnea I., M.D..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
Chap, Linnea I., M.D.
ClinicalTrials.gov Identifier:
NCT00378638
First received: September 18, 2006
Last updated: October 23, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab combined with dose dense chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymp Node Positive Breast Cancer: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Chap, Linnea I., M.D.:

Primary Outcome Measures:
  • Incidence of treatment failure, 2 and 5 year Disease Free Survival.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: June 2006
Estimated Study Completion Date: October 2008
Detailed Description:

Approximately 200,000 women are diagnosed with breast cancer in the United States every year. A significant factor determining long-term survivability of breast cancer is whether or not lymph nodes, glands which cleanse and filter the body's fluids, are involved. Despite treatment with approved multiagent cytotoxic chemotherapy ("dose-dense chemotherapy"), women with breast cancer involving more than 4 axillary lymph nodes still have a high risk for recurrence.

Several dose-dense chemotherapy regimens are currently being compared in other studies, however, at this time there is no proof that one regimen is superior to another. Therefore, in an attempt to decrease metastases, prolong time to recurrence and improve overall survival, it is essential to develop novel therapeutic strategies. The use of inhibitors of angiogenesis represents a promising option.

Bevacizumab is the first angiogenesis inhibiting drug to be FDA approved, for the treatment of colon cancer. It is has also been studied alone in progressed lymph-node positive breast cancer and has shown moderate efficacy.

This study will observe the efficacy and tolerability of using bevacizumab in combination with an approved dose-dense chemotherapy regimen for 8 cycles, followed by 12 of bevacizumab alone. Patients may be on the study for up to 52 weeks if their disease has not progressed and the regimen is tolerated.

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
  • Pregnant (positive pregnancy test) or lactating
  • Urine protein:creatinine ratio >1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound, ulcer, or bone fracture
  • Inability to comply with study and/or follow-up procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378638

Contacts
Contact: Linnea I. Chap, MD (310) 633-8400 lchap@premiereoncology.com
Contact: Marilyn Mulay, MSN (310) 633-8400 mmulay@premiereoncology.com

Locations
United States, California
Premiere Oncology Recruiting
Santa Monica, California, United States, 90404
Contact: Linnea I. Chap, M.D.    310-633-8400    lchap@premiereoncology.com   
Contact: Marilyn Mulay, MSN    (310) 633-8400    mmulay@premiereoncology.com   
Principal Investigator: Linnea I. Chap, M.D.         
Sponsors and Collaborators
Chap, Linnea I., M.D.
Genentech
Investigators
Principal Investigator: Linnea I. Chap, MD Premiere Oncology, A Medical Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00378638     History of Changes
Obsolete Identifiers: NCT00372866
Other Study ID Numbers: AVF3359s
Study First Received: September 18, 2006
Last Updated: October 23, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Chap, Linnea I., M.D.:
lymph
node
positive
breast
cancer
metastases
angiogenesis
bevacizumab
chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014