Neoplasms

Symptoms and General Pathology

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Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

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Antineoplastic Agents

Hormones

Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

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Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Definitive surgery without preoperative AI treatment

Treatment with letrozole for 4 months before definitive surgery.

letrozole (Femara)

Bent Ejlertsen, MD, PhD

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.

The Danish Medical Research Council

Danish Cancer Society

Novartis

Danish Breast Cancer Cooperative Group

Professor, MD, PhD

Menopause

Antibodies

Immunoglobulins

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer	NCT00908531	Operable Breast...	letrozole (Fema...	60 Years -	Danish Breast Cancer Cooperative Group
Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer	NCT00530868	Breast Cancer Cancer of the B... Breast Neoplasm	Letrozole (Fema... Letrozole; Avas...	19 Years -	University of Alabama at Birmingham

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