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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Novartis; Pfizer
• Treatments: Docetaxel; Epirubicin; Trastuzumab; Zoledronic Acid

Criteria

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