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Phase II Trial of Abraxane Administered on a Weekly Schedule in Combination With Bevacizumab in Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase II Trial of Abraxane Administered on a Weekly Schedule in Combination With Bevacizumab in Metastatic Breast Cancer



- Determine the activity of paclitaxel albumin-stabilized nanoparticle formulation
(ABI-007; Abraxane^®) and bevacizumab, in terms of progression-free survival and
response rate, in women with recurrent or metastatic breast cancer.


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

- Determine the feasibility of this regimen in these patients.

OUTLINE: This is an open-label, pilot study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007;
Abraxane^®) IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on
days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed invasive breast cancer

- Recurrent or metastatic disease OR locally recurrent disease not amenable to
resection with curative intent

- Measurable or nonmeasurable disease

- No CNS metastases by CT scan or MRI

- No HER2-neu-positive tumors

- Hormone receptor status not specified


- Female

- Menopausal status not specified

- Performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count > 100,000/mm³

- Creatinine < 2.0 mg/dL

- Bilirubin normal

- AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if there is known liver

- Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR ≤ 1 g
protein on 24-hour urine collection

- No peripheral neuropathy > grade 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancies within the past 5 years except carcinoma in situ of the cervix,
melanoma in situ, or basal cell carcinoma of the skin

- No inadequately controlled hypertension, defined as systolic blood pressure (BP) >
150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications

- No prior hypertensive crisis or hypertensive encephalopathy

- No New York Heart Association class II-IV congestive heart failure

- No myocardial infarction or unstable angina within the past 6 months

- No stroke or transient ischemic attack within the past 6 months

- No significant vascular disease (e.g., aortic aneurysm or aortic dissection)

- No symptomatic peripheral vascular disease

- No evidence of bleeding diathesis or coagulopathy

- No significant traumatic injury within the past 28 days

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No serious, nonhealing wound, ulcer, or bone fracture

- No known hypersensitivity to any component of bevacizumab


- No prior paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®)
or bevacizumab

- No prior chemotherapy for metastatic disease

- Prior hormonal therapy for metastatic disease allowed

- At least 4 weeks since any prior therapy for cancer

- More than 12 months since prior adjuvant chemotherapy, including use of a taxane

- More than 28 days since prior major surgery or open biopsy

- More than 7 days since prior core biopsy or minor surgery (excluding placement of a
vascular access device)

- No concurrent major surgery

- No other concurrent therapy for breast cancer

- Concurrent bisphosphonates allowed if there is bone involvement

- No concurrent prophylactic granulocyte colony-stimulating factors

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival as measured by RECIST criteria at 1 and 2 years

Safety Issue:


Principal Investigator

Linnea Chap, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Premiere Oncology


United States: Federal Government

Study ID:




Start Date:

October 2006

Completion Date:

Related Keywords:

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



Premiere Oncology Santa Monica, California  90404