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| Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer
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| Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer
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| 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.
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| Not Provided
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| Interventional
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| Phase 2
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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| Breast Neoplasms
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- Experimental: Zometa
Zometa 4 mg IV every 3 weeks for a total of 17 doses. The first treatment will be given at the time of the first chemotherapy treatment and will continue for approximately 1 year. Neoadjuvant therapy - Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery
- Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery
Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection Adjuvant therapy - Epirubicin 75 mg/m2 IV every 21 days for 2 cycles
- Docetaxel 75 mg/m2 IV every 21 days for 2 cycles
- All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery
Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks Interventions: - Drug: Zometa
- Drug: Epirubicin
- Drug: Docetaxel
- Drug: Trastuzumab
- Radiation: External beam radiation
- Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection
- Active Comparator: No Zometa
Neoadjuvant therapy - Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery
- Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery
Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection Adjuvant therapy - Epirubicin 75 mg/m2 IV every 21 days for 2 cycles
- Docetaxel 75 mg/m2 IV every 21 days for 2 cycles
- All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery
Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks Interventions: - Drug: Epirubicin
- Drug: Docetaxel
- Drug: Trastuzumab
- Radiation: External beam radiation
- Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection
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| Completed
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| 120
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| Same as current |
| May 2011
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| August 2007 (Final data collection date for primary outcome measure)
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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
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| Sexes Eligible for Study: | Female |
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| 18 Years and older (Adult, Older Adult)
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| No
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| Contact information is only displayed when the study is recruiting subjects |
| United States
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| NCT00242203
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| 02-0788 / 201104272
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| Yes
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| Not Provided
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| Not Provided
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| Washington University School of Medicine
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| Washington University School of Medicine
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| Principal Investigator: | Rebecca Aft, M.D., Ph.D. | Washington University School of Medicine |
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| Washington University School of Medicine
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| August 2013
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