Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Ian E. Krop, MD, PhD
Study ID
NCT00546156
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Doxorubicin — DRUG
    Standard chemotherapy regimen
  • Cyclophosphamide — DRUG
    Standard chemotherapy regimen
  • Paclitaxel — DRUG
    Standard chemotherapy regimen
  • Bevacizumab — DRUG
    One intravenous dose given followed 2 weeks later with standard chemotherapy drugs and bevacizumab given intravenously in 8 two-week cycles.

Study Details

Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment of ER+ or PR+ breast cancer. In this trial, the standard chemotherapy is being combined with bevacizumab. Bevacizumab is an antibody which works differently from the way other chemotherapy drugs work. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors by binding to a substance found on cancer cells called VEGF (vascular endothelial growth factor). Bevacizumab is approved by the FDA for the treatment of colorectal cancer and lung cancer. However, it is not approved for the treatment of breast cancer. Another goal of this research is to determine whether we can develop a way to identify tumors that will respond well to this study treatment.

Key Dates

First listed
Oct 18, 2007
Start date
Oct 31, 2007
Status verified
Apr 2021
Primary completion
Oct 31, 2011
Completion
Dec 31, 2012

Study Design

Enrollment
104 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: HR+, HER2-
    Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
  • Active Comparator: Triple Negative Breast Cancer Cohort
    Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.

Primary Outcome Measure

Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population. [ Time Frame: 3 Years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dana-Farber at Faulkner HospitalBostonMassachusetts02130-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
New Hampshire Oncology-Hematology PAHooksettNew Hampshire03106-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber at Faulkner Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MANew Hampshire Oncology-Hematology PA· Hooksett, NH

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