Status:
COMPLETED
Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Novartis
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00242203
Start Date
October 1 2002
End Date
May 1 2011
Last Update
August 13 2013
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110