Clinical Trial: Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer
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 women undergoing treatment for locally advanced breast cancer.
Detailed Summary:
Sponsor: Washington University School of Medicine
Current Primary Outcome:
- Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases [ Time Frame: Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration ]
- Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density [ Time Frame: Prior to therapy initiation and 12-15 months from registration ]
Original Primary Outcome:
Current Secondary Outcome:
- Impact of Zometa (zoledronic acid) on time and site of relapse [ Time Frame: 5 years from registration ]
- Effect of treatment on quality of life in women undergoing treatment for LABC. [ Time Frame: Baseline and 12-15 months from registration ]
Original Secondary Outcome:
Information By: Washington University School of Medicine
Dates:
Date Received: October 17, 2005
Date Started: October 2002
Date Completion:
Last Updated: August 9, 2013
Last Verified: August 2013
