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

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Bevacizumab, Abraxane (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Angela DeMichele, M.D., Principal Investigator, Affiliation: Abramson Cancer Center of University of Pennsylvania

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.

Clinical Details

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

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

Primary outcome: 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.

Secondary outcome:

To determine the overall response rate to bevacizumab + ABI-007 in this study population.

To determine the toxicity of bevacizumab + ABI-007 in this study population.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Abramson Cancer Center at University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: May 2007
Last updated: January 31, 2013

Page last updated: August 23, 2015

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