A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — DRUG
  bevacizumab 15 mg/kg IV every 21 days for 6 cycles followed by bevacizumab 15 mg/kg IV every 21 days until 1 year following the first dose of bevacizumab
• docetaxel — DRUG
  docetaxel 75 mg/m2 IV every 21 days for 6 cycles
• doxorubicin — DRUG
  doxorubicin 50 mg/m2 IV every 21 days for 6 cycles
• cyclophosphamide — DRUG
  Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and 3: cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles
• pegfilgrastim — DRUG
  pegfilgrastim 6 mg subcutaneous (SC) Day 2 every 21 days for 6 cycles \[filgrastim (Neupogen®) 5 mcg/kg Days 2-10 may be given in lieu of pegfilgrastim (Neulasta®), but pegfilgrastim is preferred.\]

Study Details

The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.

Key Dates

First listed

Apr 24, 2009

Start date

May 31, 2009

Status verified

Apr 2022

Primary completion

Feb 28, 2018

Completion

Feb 28, 2018

Study Design

Enrollment

1,613 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Group 1: TAC then pegfilgrastim
  docetaxel, doxorubicin, cyclophosphamide, and pegfilgrastim/filgrastim
• Active Comparator: Group 2: TC
  docetaxel and cyclophosphamide
• Experimental: Group 3: TC + bevacizumab
  docetaxel, cyclophosphamide, and bevacizumab

Primary Outcome Measure

Invasive disease-free survival(IDFS)relative to the TAC chemotherapy regimen alone [ Time Frame: Every 12 months until recurrence ]

Locations (522)

Find similar trials in Bessemer, AL

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