Trial Information

Combined Targeted Therapies for Triple Negative Advanced Breast Cancer - A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy With Bevacizumab and Erlotinib

This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with metastatic breast cancer.

Patient Inclusion Criteria:

Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor (HER)-2 non-overexpressing
Be receiving first-line therapy for metastatic disease
Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; Xrays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; Xrays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration
OR Non-measurable disease only, with rising serum CA15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration
AND the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy if able to bear children
Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines

Patient Exclusion Criteria:

Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane
Central nervous system (CNS) metastases
Pre-existing nephritic syndrome
Serious intercurrent medical or psychiatric illness including serious active infection
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)
Known hypersensitivity to any component of bevacizumab

Christine Goetz, BA; CCRC
MultiCare Health System
314 Martin Luther King, Jr. Way, Suite 402
Tacoma, WA 98405
Phone: 253-403-7193
Email: Christine.Goetz@multicare.org

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Research Center Information: MultiCare Health System

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