Clinical Trial Details


Research Study Summary

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

To Learn more

CW ID: 183316
Date Last Changed: September 17, 2012

Clinical Trial Snapshot

Both Male and Female
Overall Status
Facility Type


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

View Map

Research Center Information:

MultiCare Health System

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.