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

Breast Neoplasms Clinical Trial

Official title:

Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242203
• Other study ID #: 02-0788 / 201104272
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2005
• Last updated: August 9, 2013
• Start date: October 2002
• Est. completion date: May 2011

Study information

• Verified date: August 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2011
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Zometa

• Epirubicin

• Docetaxel

• Trastuzumab
ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH

Radiation:
• External beam radiation

Procedure:
• Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Novartis, Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (29)

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Yin J, Chirgwin J, Taylor S: Dominant negative blockade of the transforming growth factor beta type II receptor decreases breast cancer mediated osteolysis. Journal of Bone and Mineral Research 11:180, 1996

Yoneda T, Michigami T, Yi B, Williams PJ, Niewolna M, Hiraga T. Actions of bisphosphonate on bone metastasis in animal models of breast carcinoma. Cancer. 2000 Jun 15;88(12 Suppl):2979-88. Review. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases		Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration	No
Primary	Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density		Prior to therapy initiation and 12-15 months from registration	No
Secondary	Impact of Zometa (zoledronic acid) on time and site of relapse		5 years from registration	No
Secondary	Effect of treatment on quality of life in women undergoing treatment for LABC.		Baseline and 12-15 months from registration	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine