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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, WA

Clinical Trial Details

Overview

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

Purpose

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
Phase

2

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

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

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Research Center Information: MultiCare Health System

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183316

Date Last Changed: September 17, 2012


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