Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT00242203

Recruitment Status:

Completed

Sponsor:

Washington University School of Medicine

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There is 1 Location for this study

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Washington University School of Medicine
St. Louis Missouri, 63110, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT00242203

Recruitment Status:

Completed

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

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