Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Letrozole

Immunoglobulins

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

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.

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

Letrozole (Femara)

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

Letrozole; Avastin

Lisle Nabell, M.D.

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.

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.

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

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

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.

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.

Genentech, Inc.

Breast Cancer Research Foundation

University of Alabama at Birmingham

Professor, Med-Hematology & Oncology

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

Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms. Hypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.

Letrozole + Avastin

Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms. Hypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.

Letrozole Alone

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

Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Study Participant

Postmenopausal women with newly diagnosed stage 2 or 3 estrogen and/or progesterone receptor-positive, HER2-negative breast cancer were randomly assigned (2:1) between letrozole 2.5 mg PO daily plus bevacizumab 15 mg/ kg IV every 3 weeks (Let/Bev) and letrozole 2.5 mg PO daily (Let) for 24 weeks prior to definitive surgery.

Lisle Nabell

Patients with postmenopausal hormone receptor positive breast cancer T2-4,N0-2 and M0 were randomized 2:1 to receive letrozole 2.5 mg PO daily and bevacizumab 15 mg/kg IV for 24 weeks or daily treatment with letrozole 2.5 mg PO alone (control arm). The duration of each cycle was 3 weeks for a total of 24 weeks. The pCR was defined as the absence of any residual invasive cancer in the resected breast specimen and lymph nodes. Data below is representative of the raw data.

The Percentage of Participants With Pathologic Complete Response

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.

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

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

Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks

This was a single arm study to test the feasibility of Letrozole with Avastin in the neoadjuvant setting.

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