NCT02547987进行中（未招募）2 期
CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery
Mothaffar Rimawi3 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年11月1日最近更新:
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）
- 发起方
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.
详细描述
PRIMARY OBJECTIVE:
To determine whether neoadjuvant docetaxel and carboplatin will increase the pCR rate in TNBC compared to historical controls. Pathologic complete response (pCR) will be defined as no residual invasive breast cancer in the breast and ipsilateral axillary lymph node (ypT0-is ypN0).
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
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be 18 years of age or older.
- •All patients must be diagnosed with invasive breast cancer.
- •Breast cancer must be ER-negative, and HER-2 negative according to CAP/ASCO biomarkers testing guidelines. Tumors may be PgR positive with an Allred score of less than
- •Primary breast tumor size at least 2 cm in one dimension by clinical or radiographic exam. Patients who have multicentric breast cancer are eligible if each lesion is estrogen receptor negative and HER2-negative. In that case, one lesion needs to be identified as the index lesion to be followed for clinical response. The index lesion must also be the lesion from which core biopsies are obtained.
- •Patients with inflammatory breast cancer are eligible if they meet both of the following criteria:
- •Patient has an underlying, clinically palpable breast mass of at least 2cm, AND
- •a corresponding lesion is visualized on mammogram or ultrasound
- •Normal bone marrow and organ function as defined below:
- •Leukocytes > 3,000/mcL
- •Absolute neutrophil count > 1,200/mcl
- •Platelets > 100,000/mcl
- •Serum bilirubin ≤ institutional 1.5 times upper limit of normal (ULN)
- •Aspartate aminotransferase/alanine aminotransferase ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 ULN
- •Women of childbearing potential (defined as women under the age of 55 with intact ovaries and uterus) must agree to use adequate contraception prior to study entry and for the duration of study participation. They must also have a negative urine pregnancy test within 7 days of starting treatment.
- •Ability to understand and willingness to sign an IRB approved written informed consent document and follow study procedures including willingness to undergo study biopsies.
排除标准
- •Any prior systemic therapy for breast cancer within 5 years.
- •A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- •Patients with known bilateral invasive breast cancer. Patients with contralateral in situ breast carcinoma are eligible.
- •Inflammatory breast cancer.
- •Patients with confirmed stage IV disease.
- •Currently receiving any other investigational agents.
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or carboplatin.
- •Known to be seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •If the patient is otherwise not deemed a good study candidate by sole discretion of the principal investigator.
- •Patient is pregnant or breastfeeding.
研究组 & 干预措施
Docetaxel/Carboplatin
Experimental
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
干预措施: Docetaxel (Drug)
Docetaxel/Carboplatin
Experimental
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
干预措施: Carboplatin (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
This is the complete disappearance of invasive cancer in the breast at the time of surgery
次要结局
未报告次要终点
研究者
Mothaffar Rimawi
Associate Professor
Baylor Breast Care Center
研究点 (3)
Loading locations...
相似试验
已完成
2 期
A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate CancerProstate CancerNCT00134706Dana-Farber Cancer Institute30
终止
2 期
A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic IrradiationAdvanced Endometrial Adenocarcinoma, Stage III A, B, CNCT00285415Carilion Clinic46
Unknown
2 期
Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal CancerNasopharyngeal CarcinomaNCT01614938Fudan University46
终止
2 期
Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate CancerProstate CancerNCT00577356Benaroya Research Institute6
终止
2 期
Docetaxel, Carboplatin, and Bevacizumab in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed By SurgeryLung CancerNCT00293332University of California, San Francisco1