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A Phase II Trial of Bevacizumab and ABI-007 (Abraxane) as Second-line Therapy in Her-2 Negative, Hormone Receptor Negative Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Trial of Bevacizumab and ABI-007 (Abraxane) as Second-line Therapy in Her-2 Negative, Hormone Receptor Negative Metastatic Breast Cancer

Inclusion Criteria:

- Female, aged 18 years or older and able to give informed consent.

- Histologically- or cytologically-proven adenocarcinoma of the breast at time of first

- ECOG performance status 0 or 1

- Life expectancy > 12 weeks

- Stage IV disease and have at least one lesion measurable by standard RECIST criteria

- Disease progression after at least one prior chemotherapy regimen for metastatic
disease or within 12 months of adjuvant chemotherapy initiation.

- All chemotherapy must be stopped > 2 weeks before enrollment.

- Primary or metastatic tumor must be negative for estrogen and progesterone receptor
expression. Testing must be done in a CLIA-approved laboratory.

- Primary or metastatic tumor must have 0 or 1+ staining for HER2/neu identified
immunohistochemically (IHC), by an approved method using one of the standard
monoclonal or polyclonal antibodies (HercepTest, cb-11, PAb1, or TAB250), or if FISH
status is known, it must be negative. Testing must be done in a CLIA-approved

- Left ventricular ejection fraction must be >= institutional lower limit of normal as
determined by MUGA or echocardiogram

- Patient must be able to comply with treatment and follow-up procedures:

- Adequate bone marrow, liver and renal function; Absolute neutrophil count >=
1500/mm3; Hemoglobin >= 10 g/dl; Platelet count >= 100,000/mm3; Creatinine <= 2.0;
PTT and either INR or PT < 1.5x normal; Total bilirubin <= 1.5 X upper limit of
normal; AST, ALT, and alkaline phosphatase <= 2 X upper limit of normal (or <= 5X
upper limit of normal if known liver metastases)

- If female is of childbearing potential, pregnancy test must be negative and patient
must be willing to use effective contraception while on treatment and for at least 3
months after the last dose of study medication

Exclusion Criteria:

- Prior treatment with VEGF targeted therapy

- Prior taxane therapy for metastatic disease or for adjuvant therapy within the
previous 12 months

- History of prior cancer, excluding carcinoma in situ of the cervix and non-melanoma
skin cancers

- Known CNS disease

- Inadequately controlled hypertension (defined as systolic blood pressure>150 and/or
diastolic blood pressure>100 mmHg on antihypertensive medications)

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to study

- History of stroke or transient ischemic attack within 6 months prior to study

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment or anticipation of need for major surgical procedure during
the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to study enrollment

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment

- Serious, non-healing wound, ulcer or bone fracture

- Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC)
ratio >1.0 at screening OR Urine dipstick for proteinuria >2+ (patients discovered to
have >2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour
urine collection and must demonstrate <1g of protein in 24 hours to be eligible)

- Patients with active infection

- Women who are pregnant or lactating

- Radiation therapy within 3 weeks of study entry

- Patients with hypersensitivity to ABI-007, Chinese hamster ovary cell products, or
other recombinant human antibodies

- Baseline neuropathy > grade 2

- Participation in an investigational study of an antineoplastic agent within 4 weeks
of first infusion of this study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine progression-free survival among women receiving bevacizumab + ABI-007 given as second-line combination therapy for hormone receptive negative, Her-2 negative metastatic breast cancer.

Outcome Time Frame:

Study Completion

Safety Issue:


Principal Investigator

Angela DeMichele, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of University of Pennsylvania


United States: Institutional Review Board

Study ID:

UPCC 02106



Start Date:

May 2007

Completion Date:

April 2011

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Metastatic breast cancer
  • Second-Line Therapy
  • Triple Negative
  • Her-2 negative
  • Hormone receptor negative
  • Abraxane
  • Bevacizumab
  • Breast Neoplasms



Abramson Cancer Center at University of PennsylvaniaPhiladelphia, Pennsylvania  19104