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

NCT00530868 | Completed Phase 2 Results DMC

• 2 other identifiers: F061229006UAB 0648
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer; Cancer of the Breast; Breast Neoplasm

Keywords

Hormonal and antibody therapy for breast cancer; Hormonal therapy for breast cancer; Antibody therapy for breast cancer

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With Pathologic Complete Response

  Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen.

  24 weeks

Secondary Outcomes (1)

• Letrozole +Avastin

  24 weeks

Study Arms (2)

Letrozole + Avastin

EXPERIMENTAL

50 evaluable patients received the combination therapy of 2.5 gm daily oral Letrozole and Avastin 15 mg/kg IV every 3 weeks for 24 weeks.

Drug: Letrozole; Avastin

Letrozole alone

EXPERIMENTAL

25 evaluable patients received daily oral 2.5 mg letrozole as a single agent

Other: Letrozole (Femara)

Interventions

Letrozole (Femara) OTHER

Letrozole 2.5 mg PO a day for 24 weeks

Letrozole alone

Letrozole; Avastin DRUG

Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks

Also known as: Femara (Letrozole)

Letrozole + Avastin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Genentech, Inc.: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294 - 0104, United States

Location

University of California, San Francisco Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Georgia Cancer Specialists

Atlanta, Georgia, 30341, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7600, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Lisle Nabell
• Organization: UAB

Lnabell@uabmc.edu

205 934-3061

Study Officials

• Lisle Nabell, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Med-Hematology & Oncology

Study Record Dates

• First Submitted: September 14, 2007
• First Posted: September 18, 2007
• Study Start: October 8, 2007
• Primary Completion: March 1, 2022
• Study Completion: March 31, 2022
• Last Updated: October 21, 2022
• Results First Posted: October 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)