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Docetaxel With or Without Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217672
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether giving docetaxel together with bevacizumab is more effective than docetaxel alone in treating breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab
Drug: docetaxel
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Docetaxel Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for HER2-Negative Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of response rates, duration of response, and overall survival [ Designated as safety issue: No ]
  • Comparison of safety and toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: April 2005
Detailed Description:

OBJECTIVES:

Primary

  • Compare the antitumor activity of docetaxel with vs without bevacizumab, in terms of time to disease progression, in women with HER2-negative stage IV breast cancer.

Secondary

  • Compare response rates, duration of response, and overall survival of patients treated with these regimens.
  • Compare the safety and toxicity of these regimens in these patients.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to prior adjuvant and/or neoadjuvant chemotherapy (none vs prior chemotherapy without a taxane vs prior chemotherapy with a taxane). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience unacceptable toxicity due to docetaxel may continue on bevacizumab alone until disease progression or bevacizumab-related unacceptable toxicity.

After completion of study treatment, patients are followed within 30 days and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study within 3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast

    • Stage IV disease
  • HER2-negative disease, by fluorescence in situ hybridization
  • Measurable disease, defined as ≥ 1 measurable lesion
  • No history of or current CNS or brain metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 24 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • No evidence of bleeding diathesis or coagulopathy

Hepatic

  • Bilirubin normal (unless due to Gilbert's disease)
  • Meets 1 of the following criteria:

    • Alkaline phosphatase (AP) normal AND AST or ALT ≤ 2.5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal

Renal

  • Creatinine ≤ 2.0 mg/dL
  • Urine protein < 1+ by dipstick urinalysis OR
  • Urine protein < 1 g by 24-hour urine collection
  • No clinically significant impaired renal function

Cardiovascular

  • No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction or stroke within the past 6 months
  • No unstable angina
  • No serious cardiac arrhythmia requiring medication
  • No clinically significant (≥ grade 2) peripheral vascular disease
  • No other clinically significant cardiovascular disease

Gastrointestinal

  • No active peptic ulcer disease
  • No inflammatory bowel disease
  • No other gastrointestinal condition that would increase the risk of perforation
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No significant traumatic injury within the past 4 weeks
  • No neuropathy ≥ grade 2
  • No non-healing wound, fracture, or ulcer
  • No active uncontrolled infection requiring parenteral antibiotics
  • No history of severe hypersensitivity reaction to study drugs or other drugs formulated with polysorbate 80
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other medical or psychiatric disorder that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior antiangiogenic agents

Chemotherapy

  • Prior adjuvant chemotherapy allowed

    • At least 12 months since prior adjuvant taxane therapy
  • No prior chemotherapy for metastatic breast cancer

Endocrine therapy

  • Prior endocrine therapy for metastatic breast cancer allowed
  • At least 4 weeks since prior endocrine therapy
  • No concurrent endocrine therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • At least 4 weeks since prior major surgical procedure or open biopsy
  • More than 1 week since prior minor surgery, fine-needle aspiration, or core biopsy
  • No concurrent major surgery

Other

  • Recovered from all prior therapy
  • At least 4 weeks since prior experimental drug therapy
  • No concurrent prophylactic antibiotics
  • No concurrent amifostine
  • No concurrent dexrazoxane
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217672

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000442877, UCLA-0501049-01, TORI-B-01
Study First Received: September 20, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00217672  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Study placed in the following topic categories:
Docetaxel
Skin Diseases
Breast Neoplasms
Bevacizumab
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009