Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer
Completed · Phase 2
Conditions studied: Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00242203
- Run by
- Washington University School of Medicine
- People needed
- 120
- Starts
- 2002-10-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2013-08-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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