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Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer



- Determine the response rate in patients with metastatic breast cancer treated with
docetaxel, capecitabine, and bevacizumab as first-line chemotherapy.


- Determine time to disease progression in patients treated with this regimen.

- Determine survival of patients treated with this regimen.

- Determine the toxicity profile of this regimen in these patients.

- Determine the duration of response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1.
Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity. Patients achieving a
complete response (CR) receive at least 2 additional courses beyond CR.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study within 8 months.

Inclusion Criteria


- Histologically or cytologically confirmed invasive breast cancer

- Clinical evidence of metastatic disease

- No bone metastases as the only evidence of metastasis

- Measurable disease

- At least 1 lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan

- Lesions on chest x-ray allowed provided they are clearly defined and
surrounded by aerated lung

- Clincal lesions only considered measurable when they are superficial (e.g., skin
nodules or palpable lymph nodes)

- Target lesion must not have been exposed to prior radiotherapy unless disease
has progressed since completion of radiotherapy

- The following are not considered measurable disease:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis or pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- No HER2/neu-positive tumors by immunohistochemistry or amplified fluorescence in situ
hybridization unless disease has progressed after trastuzumab (Herceptin®)-containing
therapy alone or with antiestrogen hormonal therapy for metastatic disease OR
trastuzumab is contraindicated

- Prior breast cancer allowed

- No prior or active brain metastases

- Hormone receptor status:

- Not specified



- 18 and over


- Male or female

Menopausal status

- Not specified

Performance status

- ECOG 0-1

Life expectancy

- At least 3 months


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

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

- No bleeding diathesis or uncontrolled coagulopathy


- Bilirubin normal

- Meets 1 of the following criteria:

- AST and ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal

- AST and ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN

- AST and ALT ≤ 5 times ULN AND alkaline phosphatase normal


- Creatinine clearance ≥ 30 mL/min

- No proteinuria OR

- Protein < 1 g by 24-hour urine collection

- No nephrotic syndrome


- No uncontrolled hypertension (i.e., blood pressure > 160/90 mm Hg on ≥ 2 different
observations ≥ 5 minutes apart)

- Blood pressure < 140/90 mm Hg on ≥ 3 different observations over ≥ 14 days, for
patients who recently began or adjusted anti-hypertensive medication

- No atrial or venous thrombosis within the past month

- No clinically significant heart disease, including any of the following:

- Congestive heart failure

- Symptomatic coronary artery disease

- Uncontrolled cardiac arrhythmias

- Unstable angina

- No myocardial infarction within the past 12 months

- No history of cerebrovascular accident


- No hemoptysis within the past 6 months


- No lack of physical integrity of the upper gastrointestinal tract

- No malabsorption syndrome

- Able to receive oral medication


- No other stage III or IV invasive malignancy requiring treatment within the past 5

- No pre-existing peripheral neuropathy > grade 1

- No history of allergy or hypersensitivity to study drugs, agents that are chemically
similar to study drugs, or drugs that contain polysorbate 80

- No prior severe reaction to fluoropyrimidines

- No known hypersensitivity to fluorouracil

- No known dihydropyrimidine dehydrogenase deficiency

- No active infection

- No significant medical condition that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study


Biologic therapy

- See Disease Characteristics

- No other concurrent biologic therapy


- Prior adjuvant or neoadjuvant chemotherapy allowed for primary disease

- No prior chemotherapy for metastatic disease

- More than 4 weeks since prior cytotoxic chemotherapy

- More than 6 months since prior taxanes (e.g., docetaxel or paclitaxel)

- No other concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- Prior antiestrogen hormonal therapy allowed in the adjuvant or metastatic setting


- See Disease Characteristics

- More than 4 weeks since prior radiotherapy to a target lesion

- Prior single-dose palliative radiotherapy allowed within the past 4 weeks

- No concurrent radiotherapy


- More than 4 weeks since prior major surgery


- More than 2 weeks since prior aspirin, anticoagulants, or thrombolytic agents

- Concurrent low-dose warfarin (1 mg/day) to maintain patency of vascular access
device allowed

- More than 4 weeks since prior investigational agents

- No concurrent aspirin, anticoagulants, or thrombolytic agents

- No concurrent participation in another clinical trial involving investigational
agents or procedures

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed tumor response (complete or partial) rate as measured by RECIST

Safety Issue:


Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

December 2004

Completion Date:

Related Keywords:

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