NCT02422498进行中（未招募）2 期
A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 7
- 主要终点
- Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
研究概览
简要总结
The study is being done to find out if the results of a pre-treatment biopsy can predict response to cisplatin and radiation treatment for patients with metastatic or recurrent triple negative breast cancer.
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
- •Histologically-confirmed invasive triple negative breast cancer (ER <1%, PR <1%, her-2-neu 0-1+ by IHC or FISH-negative) or as determined by MD discretion
- •Radiation to the recurrent or metastatic site is clinically indicated and would be considered standard care for palliation or for locoregional control
- •Age ≥18 years
- •Tumor to be irradiated is measurable by RECIST 1.1 or PRC
- •Willingness to undergo tumor biopsy prior to initiation of treatment
- •Life expectancy greater than 6 months
- •ECOG performance status 0-2
- •Any prior chemotherapy is allowed including prior treatment with platinum-containing chemotherapy
- •Prior treatment with FDA-approved or investigational biologics or novel molecularly target therapies, including oral or IV formulations, are permitted.
- •Patients must be off prior targeted therapy for at least 14 days prior to study biopsy.
- •Use of an effective means of contraception in women of child-bearing potential
- •Ability to comprehend and sign informed consent
- •Adequate organ and marrow function within 14 days prior to study entry, defined as:
- •Absolute neutrophil count (ANC)>1000/mm3
- •Hemoglobin >9 gm/dl
- •Platelets >100,000/mm3
- •Serum creatinine <1.5 mg/dl OR creatinine clearance of ≥ 50 cc/min
- •SGOT/SGPT<2.5X institutional ULN (<5X ULN if known liver metastases)
排除标准
- •Unmeasurable target tumor site by RECIST 1.1 or PRC (ex: lesions <2 cm on CT or MR scan, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis, non-FDG-avid skin lesions)
- •Brain metastases requiring focal or whole brain radiation will be excluded, as these lesions cannot be biopsied and can have life expectancies <6 months.
- •Inability to obtain a biopsy of the tumor as deemed by the study Interventional Radiologist
- •Prior chemotherapy completed <7 days prior to planned study entry
- •Prior RT is allowed and must have been completed more than 7 days before planned study entry.
- •Note: For re-irradiation cases, standard departmental guidelines should be followed so as to not exceed normal tissue
- •Life expectancy less than 6 months
- •Intercurrent illness or other major medical condition or comorbid condition that might affect study participation (uncontrolled renal, pulmonary or hepatic dysfunction or infection)
- •Renal dysfunction for which cisplatin dose would be considered unsafe.
- •Women on study must be neither pregnant nor nursing nor expected to become pregnant during therapy. For premenopausal women, negative pregnancy test within 14 days of RT is required.
- •Concurrent active malignancy other than non-melanomatous skin cancer or carcinoma in-situ of the cervix, unless treatment for the previous cancer was completed >2 years prior to study entry and patient has remained disease-free.
研究组 & 干预措施
Concurrent Cisplatin & Radiation Therapy
Experimental
干预措施: external beam radiation therapy (Radiation)
Concurrent Cisplatin & Radiation Therapy
Experimental
干预措施: cisplatin (Drug)
Concurrent Cisplatin & Radiation Therapy
Experimental
干预措施: Biopsy of Target Tumor (Procedure)
结局指标
主要结局
Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
时间窗: 2 years from baseline
RECIST 1.1 as measurement tools for treatment response.
次要结局
未报告次要终点
研究者
研究点 (7)
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