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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00530868
Recruitment Status : Completed
First Posted : September 18, 2007
Last Update Posted : November 23, 2020
Genentech, Inc.
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Carolina Salvador, University of Alabama at Birmingham

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Cancer of the Breast Breast Neoplasm Other: Letrozole (Femara) Drug: Letrozole; Avastin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : October 8, 2007
Actual Primary Completion Date : November 6, 2020
Actual Study Completion Date : November 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Clinical objective response; tolerability and toxicity; biomarkers for prognostic value. [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00530868

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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, Inc.
Breast Cancer Research Foundation
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Principal Investigator: Carolina Salvador, M.D. University of Alabama at Birmingham
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Responsible Party: Carolina Salvador, Assistant Professor, Medicine, University of Alabama at Birmingham Identifier: NCT00530868    
Other Study ID Numbers: F061229006
UAB 0648 ( Other Identifier: Institutional protocol study number )
First Posted: September 18, 2007    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carolina Salvador, 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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists