Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall Response
研究概览
简要总结
The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself and create more tumor cells, and cause the tumor cells to die.
详细描述
After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative
Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Sentinel Lymph node biopsy, if axillary US negative
Week 1: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 1) Days 2-5: Radiation Therapy
Week 2: Radiation Day 1-5: Radiation Therapy
Week 3: Radiation Days 1-5: Radiation Therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must be >= 18 years of age
- •Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
- •Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).
- •Tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, Her2/neu
- •Adequate organ function defined as:
- •Serum Creatinine <= 1.5 x upper limit of institutional normal.
- •ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.
- •Bilirubin <= 1.5 x upper limit of institutional normal.
- •Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.
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 should be further clarified by additional testing such as PET or MRI.
- •No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
- •Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
- •Karnofsky Performance Status of <=
- •Patients with known history neural deficiencies (e.g. peripheral neuropathy).
- •Patients with a known hearing impairment (hearing loss or severe tinnitus).
- •Male patients
研究组 & 干预措施
Cisplatin + Radiation + Recommended Surgery
Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
干预措施: Cisplatin (Drug)
Cisplatin + Radiation + Recommended Surgery
Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
干预措施: Radiation Therapy (Radiation)
Cisplatin + Radiation + Recommended Surgery
Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
干预措施: Mastectomy (Procedure)
结局指标
主要结局
Overall Response
时间窗: At the time of surgery (week 13)
* Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level * Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD * Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, * Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions.
次要结局
- Overall Survival Rate (OS)(Until study was terminated (23.5 months))
- Number of Participants With Surgical Complications(30 days post surgery (week 17-18))
- Number of Participants With Medical Toxicities(30 days post surgery (week 17-18))
- Time to Disease Progression(Until study was terminated (23.5 months))
- Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response(5 years)
- Develop Animal Models of Triple Negative Breast Cancers(5 years)
- Provide Samples for the Development of the FNA Assay(At time of IVAD placement and at time of surgery)