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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530868
• Other study ID #: F061229006
• Secondary ID: UAB 0648
• Status: Completed
• Phase: Phase 2
• Start date: October 8, 2007
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 31, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm
• Breast Neoplasms
• Cancer of the Breast

Intervention

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

Locations

Country	Name	City	State
United States	Georgia Cancer Specialists	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of California, San Francisco Comprehensive Cancer Center	San Francisco	California
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Breast Cancer Research Foundation, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Letrozole +Avastin	Radiographic objective response to the therapy are reported. Radiographic response was assessed using RECIST criteria by ultrasound or breast MRI through the study and are reported as complete radiographic response below.	24 weeks