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A Phase II Study of Abraxane, Bevacizumab and Gemcitabine for First Line Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Phase II Study of Abraxane, Bevacizumab and Gemcitabine for First Line Metastatic Breast Cancer



- To determine preliminary evidence of efficacy of the combination regimen of gemcitabine
hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), and
bevacizumab as first-line treatment for Her2/neu-negative metastatic (stage IV) breast


- To determine the partial, complete, and overall response rate.

- To determine the safety and side effect profile of the treatment combination.

- To explore the relationship between circulating tumor cells (CTC) and disease
progression, by measuring CTC at baseline and over the course of treatment.

OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by
paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes
followed by bevacizumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative
laboratory studies. Tumor tissue samples are analyzed for secreted protein acidic rich in
cysteine (SPARC) expression by antibody immunostaining. Blood samples are analyzed for the
presence of circulating tumor cells by the CellSearch™ system.

After completion of study treatment, patients are followed at 1 year and then annually

Inclusion Criteria


- Patients must meet 1 of the following criteria:

- Treatment-naïve with newly diagnosed Her2/neu non-overexpressing (non amplified)
metastatic (stage IV) breast cancer

- HER2/neu-negative breast cancer with metastasis diagnosed 6 or more months after
completing primary systemic treatment (i.e., neoadjuvant or adjuvant

- Measurable disease as defined by RECIST criteria OR evaluable disease

- No CNS or brain metastases


- Inclusion Criteria

- Pre- or postmenopausal

- ECOG performance status 0-1

- Life expectancy > 3 months

- Female or male patients must be surgically sterilized or willing to use an
acceptable method of birth control for the duration of the study

- Neutrophils ≥ 1.5 x 10^9/L

- Platelets ≥ 100 x 10^9/L

- Hemoglobin ≥ 9.0 g/dL

- Serum creatinine ≤ 1.5 mg/dL

- Bilirubin ≤ upper limit of normal (ULN), except when caused by metastatic

- ALT/AST ≤ 2.5 times ULN, except when caused by metastatic disease

- Urine protein:creatinine (UPC) ratio < 1.0 at screening

- Exclusion Criteria

- Pregnant (positive pregnancy test) or lactating

- History of gastrointestinal bleeding within the past 3 months

- Inadequately controlled hypertension (i.e., systolic BP > 150 mm Hg and/or
diastolic BP > 100 mm Hg while on antihypertensive medications)

- Prior history of hypertensive crisis or hypertensive encephalopathy

- Peripheral neuropathy > grade 1

- Clinical AIDS or known positive HIV serology

- No concurrent clinically evident malignancy except for inactive nonmelanoma skin
cancer, inactive cervical cancer, or other cancer for which the patient has been
disease-free for 5 years

- Unstable angina

- New York Heart Association class II-IV congestive heart failure

- History of myocardial infarction within the past 6 months

- History of stroke within the past 6 months

- Clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 6 months

- Serious nonhealing wound, ulcer, or bone fracture

- Serious medical or psychiatric illness that would render chemotherapy unsafe

- Significant traumatic injury within the past 28 days


- Exclusion Criteria

- Previous chemotherapy for metastatic breast cancer

- Previous treatment with gemcitabine hydrochloride

- Chemotherapy within 4 weeks prior to study enrollment

- Radiation therapy or evidence of acute effects of radiation therapy within 2
weeks prior to study enrollment

- Any major surgery or open biopsy within 4 weeks prior to study enrollment

- Minor surgical procedures (i.e., fine needle aspirations or core biopsies)
within 7 days prior to study enrollment

- Participation in another experimental drug study (other than a bevacizumab
clinical trial for cancer) within 4 weeks prior to study enrollment

- Anticipation of need for major surgical procedure during the course of the study

- Concurrent irradiation

- Other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Stefan Gluck, MD, PhD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

March 2011

Related Keywords:

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



University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136