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

The Washington University

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Docetaxel; Drug: Zometa; Drug: Epirubicin; Radiation: External beam radiation; Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection; Drug: Trastuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00242203

02-0788 / 201104272

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Zometa

Experimental group

Description:

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

Treatment:

Drug: Trastuzumab

Drug: Epirubicin

Radiation: External beam radiation

Drug: Zometa

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

Drug: Docetaxel

No Zometa

Active Comparator group

Description:

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

Treatment:

Drug: Trastuzumab

Drug: Epirubicin

Radiation: External beam radiation

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

Drug: Docetaxel