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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab combined with dose dense chemotherapy
Sponsored by
Chap, Linnea I., M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring lymph, node, positive, breast, cancer, metastases, angiogenesis, bevacizumab, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Premiere OncologyRecruiting

Outcomes

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.

Full Information

First Posted
September 18, 2006
Last Updated
October 23, 2007
Sponsor
Chap, Linnea I., M.D.
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00378638
Brief Title
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study
Official Title
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymp Node Positive Breast Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chap, Linnea I., M.D.
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
lymph, node, positive, breast, cancer, metastases, angiogenesis, bevacizumab, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bevacizumab combined with dose dense chemotherapy
Primary Outcome Measure Information:
Title
Incidence of treatment failure, 2 and 5 year Disease Free Survival.
Secondary Outcome Measure Information:
Title
2 and 5 Year Disease Free Survival.
Title
Overall survival.
Title
Circulating Tumor Cells and Circulating Endothelial Progenitor Cells assays results and their association with clinical outcomes.
Title
Toxicities and adverse events.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linnea I. Chap, MD
Phone
(310) 633-8400
Email
lchap@premiereoncology.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyn Mulay, MSN
Phone
(310) 633-8400
Email
mmulay@premiereoncology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linnea I. Chap, MD
Organizational Affiliation
Premiere Oncology, A Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Premiere Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linnea I. Chap, M.D.
Phone
310-633-8400
Email
lchap@premiereoncology.com
First Name & Middle Initial & Last Name & Degree
Marilyn Mulay, MSN
Phone
(310) 633-8400
Email
mmulay@premiereoncology.com
First Name & Middle Initial & Last Name & Degree
Linnea I. Chap, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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