bevacizumab and abraxane as second-line therapy in triple negative metastatic breast cancer

Conditions: Breast Cancer

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.


Eligibility criteria:
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.

Keywords: breast cancer metastatic breast cancer second-line therapy triple negative her-2 negative hormone receptor negative abraxane bevacizumab