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SCCA Breast Cancer Clinical Trials

Targeted Therapies for Triple Negative Advanced Breast Cancer (6628)
Combined Targeted Therapies for Triple Negative Advanced Breast Cancer - A Phase II Trial of Weekly Nab-Paclitaxel (Abraxane) and Bevacizumab (Avastin) Followed by Maintenance Targeted Therapy With Bevacizumab (Avastin) and Erlotinib (Tarceva)
Status Conditions Phase Study ID
Recruiting Breast Cancer Phase II UWCC-6628
NCT00733408
Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with bevacizumab and erlotinib may kill more tumor cells.

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


Investigator
Jennifer Specht, MD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Bozeman Deaconess Cancer Center, Bozeman, MT 406-585-5070  
Cascade Cancer Center, Kirkland WA 425-285-3928  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Overlake Hospital Medical Center, Bellevue WA 425-688-5407  
Providence Alaska Medical Center, Anchorage AK 907-212-3109  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Columbia Basin Hematology & Oncology, Kennewick, WA 509-783-4637  
SCCA at EvergreenHealth 425-899-3337  
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Metastatic disease
  • Basaloid phenotype, as demonstrated by all of the following:

    • Estrogen receptor-negative tumor
    • Progesterone receptor-negative tumor
    • HER2/neu non-overexpressing tumor
  • Measurable disease by RECIST criteria OR nonmeasurable disease only, defined as the following:

    • Measurable disease

      • X-rays, scans, or physical examinations used for tumor measurement must have been completed within 28 days prior to registration
    • Nonmeasurable disease only

      • X-rays, scans, or other tests for assessment of nonmeasurable disease must have been performed within 42 days prior to registration
      • Rising serum CA15-3 or CA 27.29 OR CEA documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration
      • Second CA 15-3 or CA 27.29 OR CEA value must have at least a 20% increase over the first AND CA 15-3 or CA 27.29 greater than or equal to 40 units/mL OR CEA greater than or equal to 4 ng/mL
  • Planning to receive first-line therapy for metastatic disease
  • No recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • No proteinuria at screening, as demonstrated by either of the following:

    • Urine protein:creatinine ratio < 1.0
    • Proteinuria < 2+ by urine dipstick OR proteinuria ≤ 1 g by 24-hour urine collection
  • No pre-existing nephritic syndrome
  • No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No NYHA class II-IV congestive heart failure
  • No myocardial infarction or unstable angina within the past 6 months
  • No stroke or transient ischemic attack within the past 6 months
  • No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • No symptomatic peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious, non-healing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 28 days
  • No known hypersensitivity to any component of bevacizumab
  • No concurrent serious medical or psychiatric illness, including serious active infection
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 28 days since prior major surgical procedure or open biopsy
  • More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
  • No concurrent major surgical procedure
  • No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy, or radiotherapy
  • No other concurrent investigational drugs
  • Concurrent bisphosphonates allowed
Last Updated
August 07, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.