Open Label Trial for Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer
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The purpose of this study is to determine pathological response to a maximum of 18 weeks of neoadjuvant therapy using a combination of letrozole and Bevacizumab in post-menopausal women with pathologically confirmed invasive ductal cancer or invasive lobular cancer of the breast whose tumors are hormone positive.
Condition or disease
Drug: Letrozole in combination with Bevacizumab
This is an open label, single arm, and Phase II study of the combination of Letrozole and Bevacizumab in patients with newly diagnosed breast cancer. Patients meeting the eligibility criteria and who have signed the consent form will start Letrozole 2.5 mg by mouth a day and Bevacizumab 15 mg per Kg IV every 3 weeks for 18 weeks (24 weeks if still responding at week 18 if approved by the PI). After neoadjuvant therapy, participants will undergo surgical treatment and will receive adjuvant therapy according to the treating physician.
Patients will be administered Letrozole at 2.5 mg PO a day and Avastin at 15 mg/kg IV every 3 weeks for 24 weeks. Patients will then undergo surgical treatment and receive adjuvant therapy according to the treating physician.
The primary objective is to estimate the pathological complete response rate of neoadjuvant therapy in operable newly diagnosed ER+ breast cancer patients using the combination of Avastin and Letrozole. [ Time Frame: approximately 24 weeks ]
Secondary Outcome Measures :
A clinical response will be based upon the Response Evaluation Criteria in Solid Tumors (RECIST Criteria). [ Time Frame: approximately 24 weeks ]
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Layout table for eligibility information
Ages Eligible for Study:
60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast, T2-T4 / T4a-c / N0-2 / M0, with positive estrogen and/or progesterone receptors. Patients with inflammatory breast cancer will not be included (Stage IIIb). Patients previously treated patients with no measurable disease or patients with metastatic disease will be excluded.
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 (see Appendix B - consent form).
Females 60 years of age (postmenopausal).
Be ambulatory (outpatient) and have an ECOG PS <2 (Appendix F).
Patients must have measurable disease by mammogram and/or breast ultrasound. 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 2.0 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%.
No history of thrombosis during the previous year.
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)
New York Heart Association (NYHA) Grade II or greater congestive heart failure see Appendix G)