Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer

Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer

This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer.

Inclusion Criteria:

• Newly diagnosed primary invasive ductal or invasive lobular breast adenocarcinoma
• Tumor classified as clinically large T2 (2-5 cm), T3, T4 or any T with N1, N2
• Prior malignancies: limited to curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated and now > 5 years disease free
• >= 18 years of age
• Normal left ventricular function by echocardiogram or radioventriculogram
• Karnofsky Performance >= 70

Exclusion Criteria:

• No evidence of distant metastasis present by CT, Bone scan, or physical exam
• If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions may be further clarified by additional testing such as PET or MRI
• No current treatment with Zometa or other bisphosphonates
• No serious functional disorders of the liver or kidneys:
• Serum Creatinine <=2
• ALT/AST/ALK Phos <= 1.5 x upper limit of institutional normal.
• Bili <= 1.5 x upper limit of institutional normal.
• Currently not pregnant