Recruiting
Phase 2

Dose-Dense Chemotherapy & Bevacizumab

Sponsor:

Chap, Linnea I., M.D.

Code:

NCT00378638

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

bevacizumab combined with dose dense chemotherapy

Study Details

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

Study ID

NCT00378638

Start date

Jun, 2006

Status verified date

Oct, 2007

Completion date

Oct, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

bevacizumab combined with dose dense chemotherapy

Primary outcome measure

  • Incidence of treatment failure, 2 and 5 year Disease Free Survival. [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Premiere Oncology

Recruiting

Santa Monica, California, United States, 90404

Contacts

Principal Investigator:

Linnea I. Chap, M.D.

More Information

Sponsor

Chap, Linnea I., M.D.

Last update posted

Oct 24, 2007

Last verified

Oct, 2007

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Chap, Linnea I., M.D. on 2007-10-24.