Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Zometa (Drug)
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
干预措施: Epirubicin (Drug)
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
干预措施: Docetaxel (Drug)
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
干预措施: Trastuzumab (Drug)
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
干预措施: External beam radiation (Radiation)
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
干预措施: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection (Procedure)
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
干预措施: Epirubicin (Drug)
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
干预措施: Docetaxel (Drug)
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
干预措施: Trastuzumab (Drug)
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
干预措施: External beam radiation (Radiation)
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
干预措施: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection (Procedure)
结局指标
主要结局
Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases
时间窗: 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
时间窗: Prior to therapy initiation and 12-15 months from registration
次要结局
- Impact of Zometa (zoledronic acid) on time and site of relapse(5 years from registration)
- Effect of treatment on quality of life in women undergoing treatment for LABC.(Baseline and 12-15 months from registration)