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

Avastin

Letrozole (Femara)

15 mg/kg given by intravenous infusion once every 3 weeks for up to 24 weeks.

Letrozole 2.5 mg PO a day for 24 weeks

OTHER

DRUG

Letrozole (Femara)

Letrozole; Avastin

Letrozole 2.5 mg PO a day for 24 weeks

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

<p>Inclusion Criteria:</p><p>All patients must meet the following criteria to be eligible for study entry:</p><ul><li>Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast, T2-T3 &#x2F; T4a-c &#x2F; N0-2 &#x2F; M0, with positive estrogen and&#x2F;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.</li><li>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.</li><li><p>Patients must be postmenopausal, defined as one of the following:</p><ul><li>Patients &gt; 50 years of age with no spontaneous menses for at least 12 months,</li><li>Bilateral oophorectomy</li></ul></li><li>Be ambulatory (outpatient) and have an ECOG PS &lt;1.</li><li>Patients must have measurable disease by mammogram and&#x2F;or breast ultrasound (in special cases a dedicated breast MRI may be clinically indicated).
The target lesion must not have been previously irradiated.</li><li>No prior chemotherapy.</li><li>Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count &gt; 1,500&#x2F;mm3, hemoglobin &gt; 8.0 g&#x2F;dl, platelets &gt; 75,000&#x2F;mm3, total bilirubin &lt; 2 mg&#x2F;dl, serum creatinine &lt; 2 mg&#x2F;dl, Transaminases (AST, ALT) may be up to 2 x institutional upper limit of normal.
In addition &lt; 1 gr of protein in 24 hr urine collection and urine protein&#x2F;creatinine ratio &lt; 1.0.</li><li>No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.</li><li>Hypertension must be controlled (&lt;150&#x2F;100 mmHg).</li><li>Ejection Fraction &gt; 50% by echocardiogram.
(LVEF greater than 75% at baseline should be reviewed and&#x2F;or the test repeated as it may be falsely elevated).</li><li>No history of thrombosis during the previous 12 months.</li></ul><p>Exclusion Criteria:</p><ul><li>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.</li><li>Uncontrolled high blood pressure (150&#x2F;100 mmHg).</li><li>Unstable angina</li><li>New York Heart Association (NYHA) Grade III or greater congestive heart failure</li><li>History of myocardial infarction or unstable angina within 12 months</li><li>History of stroke or TIA within 12 months</li><li>Clinically significant peripheral vascular disease</li><li>History of a bleeding disorder</li><li>Presence of central nervous system or brain metastases</li><li>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</li><li>Minor surgical procedures (excluding fine needle aspirations or core biopsies) within 5 days prior to Day 0</li><li>Pregnant (positive pregnancy test) or lactating</li><li>Urine protein: creatinine ratio 1.0 at screening or patients demonstrating &gt; 1 gr of protein in 24 hr urine collection within 4 weeks prior to study entry will not participate in the trial.</li><li>History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0</li><li>Serious, non-healing wound, ulcer, or bone fracture</li><li>Unwilling or unable to comply with the protocol for the duration of the study.</li><li>Psychiatric illness&#x2F;social situations that would limit compliance with study requirements.</li><li>History of another malignancy within the last five years except non-melanoma skin cancer and carcinoma in-situ of uterine cervix.</li><li>Patients with metastatic disease.</li></ul>

<p>Inclusion Criteria:</p><p>All patients must meet the following criteria to be eligible for study entry:</p><ul><li>Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast, T2-T3 &#x2F; T4a-c &#x2F; N0-2 &#x2F; M0, with positive estrogen and&#x2F;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.</li><li>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.</li><li><p>Patients must be postmenopausal, defined as one of the following:</p><ul><li>Patients &gt; 50 years of age with no spontaneous menses for at least 12 months,</li><li>Bilateral oophorectomy</li></ul></li><li>Be ambulatory (outpatient) and have an ECOG PS &lt;1.</li><li>Patients must have measurable disease by mammogram and&#x2F;or breast ultrasound (in special cases a dedicated breast MRI may be clinically indicated).
The target lesion must not have been previously irradiated.</li><li>No prior chemotherapy.</li><li>Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count &gt; 1,500&#x2F;mm3, hemoglobin &gt; 8.0 g&#x2F;dl, platelets &gt; 75,000&#x2F;mm3, total bilirubin &lt; 2 mg&#x2F;dl, serum creatinine &lt; 2 mg&#x2F;dl, Transaminases (AST, ALT) may be up to 2 x institutional upper limit of normal.
In addition &lt; 1 gr of protein in 24 hr urine collection and urine protein&#x2F;creatinine ratio &lt; 1.0.</li><li>No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.</li><li>Hypertension must be controlled (&lt;150&#x2F;100 mmHg).</li><li>Ejection Fraction &gt; 50% by echocardiogram.
(LVEF greater than 75% at baseline should be reviewed and&#x2F;or the test repeated as it may be falsely elevated).</li><li>No history of thrombosis during the previous 12 months.</li></ul><p>Exclusion Criteria:</p><ul><li>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.</li><li>Uncontrolled high blood pressure (&gt;150&#x2F;100 mmHg).</li><li>Unstable angina</li><li>New York Heart Association (NYHA) Grade III or greater congestive heart failure</li><li>History of myocardial infarction or unstable angina within 12 months</li><li>History of stroke or TIA within 12 months</li><li>Clinically significant peripheral vascular disease</li><li>History of a bleeding disorder</li><li>Presence of central nervous system or brain metastases</li><li>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</li><li>Minor surgical procedures (excluding fine needle aspirations or core biopsies) within 5 days prior to Day 0</li><li>Pregnant (positive pregnancy test) or lactating</li><li>Urine protein: creatinine ratio greater than or equal to 1.0 at screening or patients demonstrating &gt; 1 gr of protein in 24 hr urine collection within 4 weeks prior to study entry will not participate in the trial.</li><li>History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0</li><li>Serious, non-healing wound, ulcer, or bone fracture</li><li>Unwilling or unable to comply with the protocol for the duration of the study.</li><li>Psychiatric illness&#x2F;social situations that would limit compliance with study requirements.</li><li>History of another malignancy within the last five years except non-melanoma skin cancer and carcinoma in-situ of uterine cervix.</li><li>Patients with metastatic disease.</li></ul>

The clinical response will be based on the Response Evaluation Criteria in Solid Tumors (RESIST Criteria).

Clinical objective response; tolerability and toxicity; biomarkers for prognostic value.

2007-08

2008-02

2007-09-17

2008-02-12

2007-09-18

2008-02-18

NOT_YET_RECRUITING

RECRUITING