Phase II Bevacizumab + Tax In Advanced Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
  Patients receive bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
• cyclophosphamide — DRUG
  Approximately 4 weeks after the completion of radiotherapy, patients receive cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
• docetaxel — DRUG
  Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
• doxorubicin hydrochloride — DRUG
  Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
• adjuvant therapy — PROCEDURE
  After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks. Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
• conventional surgery — PROCEDURE
  After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery.
• neoadjuvant therapy — PROCEDURE
  Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8. Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
• radiation therapy — RADIATION
  Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.

Study Details

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This randomized phase II trial is to see if docetaxel with or without bevacizumab followed by surgery, radiation therapy, and combination chemotherapy works better in treating patients who have stage III or stage IV breast cancer.

Key Dates

First listed

Jan 27, 2003

Start date

Nov 30, 2001

Status verified

Jun 2013

Primary completion

Dec 31, 2005

Completion

Aug 31, 2010

Study Design

Enrollment

49 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Docetaxel
  Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
• Experimental: Combine bevacizumab and docetaxel.
  Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.

Primary Outcome Measure

To evaluate the ability of bevacizumab and docetaxel to reduce microvessel density and induce apoptosis of endothelial and tumor cells. [ Time Frame: weeks 8 and 17 ]

Locations (5)

Find similar trials in Cleveland, OH

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