Bevacizumab and Abraxane as Second-line Therapy in Triple Negative Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Bevacizumab, Abraxane

Registration Number: NCT00472693

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary: The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 5

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 diagnosis
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 laboratory.
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 enrollment
History of stroke or transient ischemic attack within 6 months prior to study enrollment
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab and ABI-007 (Abraxane)	Bevacizumab, Abraxane	Bevacizumab and ABI-007 (Abraxane)

Primary Outcome Measures

Name	Time	Method
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.	Study Completion

Secondary Outcome Measures

Name	Time	Method
To determine the overall response rate to bevacizumab + ABI-007 in this study population.	Study completion
To determine the toxicity of bevacizumab + ABI-007 in this study population.	Study completion