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Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer
This study is currently recruiting participants.
Verified by University of Alabama at Birmingham, December 2008
Sponsors and Collaborators: University of Alabama at Birmingham
Genentech
Breast Cancer Research Foundation
Information provided by: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00530868
  Purpose

This purpose of this trial is to show that the combination of Avastin and hormone therapy should be more effective than hormone therapy alone for the treatment of breast cancer.


Condition Intervention Phase
Breast Cancer
Cancer of the Breast
Breast Neoplasm
Other: Letrozole (Femara)
Drug: Letrozole; Avastin
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Bevacizumab Immunoglobulins Globulin, Immune Letrozole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Phase II, Randomized, Open Label Trial of Pre-Operative (Neoadjuvant)Letrozole (Femara) vs. Letrozole in Combination With Avastin in Post Menopausal Women With Newly Diagnosed Operable Breast Cancer

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Pathological complete response is defined as no evidence of residual invasive tumor in the breast or axillary lymph nodes or only residual ductal carcinoma in-situ. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical objective response; tolerability and toxicity; biomarkers for prognostic value. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Letrozole plus Avastin
Other: Letrozole (Femara)
Letrozole 2.5 mg PO a day for 24 weeks
Drug: Letrozole; Avastin
Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
2: Experimental
Letrozole alone.
Other: Letrozole (Femara)
Letrozole 2.5 mg PO a day for 24 weeks
Drug: Letrozole; Avastin
Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks

Detailed Description:

Preclinical and clinical data have demonstrated that up-regulation of tumor cell VEGF is an important mechanism to subvert estrogen dependence in hormone responsive breast cancer resulting in reduced therapy response or tumor resistance to hormonal therapy; thus, it is hypothesized that the combination of an anti-VEGF agent (Avastin, an anti-VEGF monoclonal antibody) and hormonal therapy should be more effective than hormonal therapy alone for the treatment of breast cancer.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients must meet the following criteria to be eligible for study entry:

  • Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast, T2-T3 / T4a-c / N0-2 / M0, with positive estrogen and/or progesterone receptors, and Her-2-neu negative. Patients with inflammatory breast cancer will not be included (T4d). Patients previously treated patients with no measurable disease or patients with metastatic disease will be excluded.
  • Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • Patients must be postmenopausal, defined as one of the following:

    • Patients > 50 years of age with no spontaneous menses for at least 12 months,
    • Bilateral oophorectomy
  • Be ambulatory (outpatient) and have an ECOG PS <1.
  • Patients must have measurable disease by mammogram and/or breast ultrasound (in special cases a dedicated breast MRI may be clinically indicated). The target lesion must not have been previously irradiated.
  • No prior chemotherapy.
  • Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count > 1,500/mm3, hemoglobin > 8.0 g/dl, platelets > 75,000/mm3, total bilirubin < 2 mg/dl, serum creatinine < 2 mg/dl, Transaminases (AST, ALT) may be up to 2 x institutional upper limit of normal. In addition < 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio < 1.0.
  • No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.
  • Hypertension must be controlled (<150/100 mmHg).
  • Ejection Fraction > 50% by echocardiogram. (LVEF greater than 75% at baseline should be reviewed and/or the test repeated as it may be falsely elevated).
  • No history of thrombosis during the previous 12 months.

Exclusion Criteria:

  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this sponsor-investigator Bevacizumab cancer study.
  • Uncontrolled high blood pressure (>150/100 mmHg).
  • Unstable angina
  • New York Heart Association (NYHA) Grade III or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 12 months
  • History of stroke or TIA within 12 months
  • Clinically significant peripheral vascular disease
  • History of a bleeding disorder
  • Presence of central nervous system or brain metastases
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Minor surgical procedures (excluding fine needle aspirations or core biopsies) within 5 days prior to Day 0
  • Pregnant (positive pregnancy test) or lactating
  • Urine protein: creatinine ratio greater than or equal to 1.0 at screening or patients demonstrating > 1 gr of protein in 24 hr urine collection within 4 weeks prior to study entry will not participate in the trial.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound, ulcer, or bone fracture
  • Unwilling or unable to comply with the protocol for the duration of the study.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • History of another malignancy within the last five years except non-melanoma skin cancer and carcinoma in-situ of uterine cervix.
  • Patients with metastatic disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530868

Contacts
Contact: Valerie Caterinicchia, RN, BSN, OCN (205) 934-5367 Valerie.Caterinicchia@ccc.uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294 - 0104
Principal Investigator: Andres Forero, M.D.            
Sub-Investigator: Lisle Nabell, M.D.            
Sub-Investigator: John Carpenter, M.D.            
Sub-Investigator: Carla Falkson, M.D.            
United States, California
University of California, San Francisco Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Michael Pelayo     415-885-3789     pelayom@cc.ucsf.edu    
Principal Investigator: Hope Rugo, M.D.            
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Minetta Liu, M.D.     202-444-3677        
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Shannon Aranjo     317-274-8136     saranjo@iupui.edu    
Principal Investigator: Anna Maria Storniolo, M.D.            
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nicole Ryabin     617-632-6767     nryabin@partners.org    
Principal Investigator: Nancy Lin, M.D.            
United States, North Carolina
University of of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Contact: Maureen Beeler, RN, BSN     919-966-4432     maureen_beeler@med.unc.edu    
Principal Investigator: Lisa Carey, M.D.            
Sponsors and Collaborators
University of Alabama at Birmingham
Genentech
Breast Cancer Research Foundation
Investigators
Principal Investigator: Andres Forero, M.D. University of Alabama at Birmingham
  More Information

Responsible Party: UAB ( Andres Forero, M.D./Principal Investigator )
Study ID Numbers: F061229006, UAB 0648
Study First Received: September 14, 2007
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00530868  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Hormonal and antibody therapy for breast cancer
Hormonal therapy for breast cancer
Antibody therapy for breast cancer

Study placed in the following topic categories:
Antibodies
Skin Diseases
Breast Neoplasms
Letrozole
Bevacizumab
Menopause
Breast Diseases
Immunoglobulins

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009