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A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for HER2-Negative Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for HER2-Negative Metastatic Breast Cancer



- 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.


- 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.

Inclusion Criteria

Inclusion Criteria

- Female 18 and over

- Histologically or cytologically confirmed adenocarcinoma of the breast at first

- Stage IV disease, with at least one measurable lesion according to the RECIST

- HER2-negative disease, by fluorescence in situ hybridization

- ECOG performance status 0-1

- Life expectancy of at least 24 weeks

- No prior chemotherapy for metastatic breast cancer (prior endocrine therapy is

- Prior adjuvant chemotherapy is permitted. If patients received a taxane in the
adjuvant setting, at least 12 months must have elapsed since the completion of
adjuvant therapy.

- At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or
experimental drug therapy, with complete recovery from the effects of these

- If female of childbearing potential, pregnancy test is negative and willing to use
effective contraception while on treatment for at least 3 months thereafter.

- Patient is accessible and willing to comply with treatment and follow-up.

- Patient is willing to provide written informed consent prior to the performance of
any study-related procedures.

- Required laboratory values

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- Creatinine ≤ 2.0 mg/dL

- Total bilirubin < 1.0 x upper limit of normal (ULN) (patients with documents
Gilbert's syndrome are eligible).

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

Exclusion Criteria

- Prior chemotherapy for metastatic breast cancer

- Prior treatment with an anti-angiogenic agent

- Concurrent therapy with any other non-protocol anti-cancer therapy

- Current or prior history of central nervous system or brain metastases

- Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline

- Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically
significant (> grade 2) peripheral vascular disease

- History of any other malignancy within the past 5 years, with the exception of
non-melanoma skin cancer or carcinoma-in-situ of the cervix

- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [BP >
150/100]), myocardial infarction or stroke within the past 6 months, unstable angina,
New York Heart Association (NYHA) Grade II or greater congestive heart failure, or
serious cardiac arrhythmia requiring medication

- Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal
condition increasing the risk of perforation; history of abdominal fistula,
gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to
beginning therapy

- Active, uncontrolled infection requiring parenteral antimicrobials

- The presence of any other medical or psychiatric disorder that, in the opinion of the
treating physician, would contraindicate the use of the drugs in this protocol or
place the subject at undue risk for treatment complications.

- Inability to comply with the study protocol or follow-up procedures

- Pregnancy or lactation

- A history of a severe hypersensitivity reaction to Bevacizumab, or Docetaxel or other
drugs formulated with polysorbate 80.

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to beginning therapy, or anticipation of the need for a major surgical
procedure during the course of the study; minor surgical procedure, fine needle
aspiration or core biopsy within 7 days prior to beginning therapy

- Proteinuria at baseline or clinically significant impairment of renal function.
Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo
a 24 hour urine collection, which must be an adequate collection and must demonstrate
<1 gm of protein/24 hour to allow participation in the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Outcome Time Frame:

Time to disease progression

Safety Issue:


Principal Investigator

Sara Hurvitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781