Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech
Breast Cancer Research Foundation
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00530868
First received: September 14, 2007
Last updated: May 31, 2014
Last verified: May 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 75
Study Start Date: October 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole + Avastin Drug: Letrozole; Avastin
Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
Other Name: Femara (Letrozole)
Experimental: Letrozole alone Other: Letrozole (Femara)
Letrozole 2.5 mg PO a day for 24 weeks
Other Name: Letrozole (Femara)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530868

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294 - 0104
United States, California
University of California, San Francisco Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, North Carolina
University of of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7600
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

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00530868     History of Changes
Other Study ID Numbers: F061229006, UAB 0648
Study First Received: September 14, 2007
Last Updated: May 31, 2014
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

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

ClinicalTrials.gov processed this record on August 21, 2014