A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR) Rate
研究概览
简要总结
This is a single arm open label phase II study in women with clinical stage 2 or 3 triple negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.
Please note that Baylor College of Medicine (BCM) has a parallel study the same as this study. Baylor is expected to enroll approximately 19 participants that have complied with the inclusion and exclusion criteria for this study (excluded participants from BCM will include male participants or participants with inflammatory breast cancer). The investigators will pool participants and data from the BCM study and the study at Washington University School of Medicine. Pooling the data will potentially improve statistical power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Newly diagnosed AJCC7 clinical stage II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant chemotherapy as the treatment goal.
- •Patients with PR+ tumors are allowed.
- •HER2 negative by FISH or IHC staining 0 or 1+.
- •ER less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumor
- •Tumor size at least 2cm in one dimension by clinical or radiographic exam (WHO criteria). Patients with palpable lymph nodes may be enrolled regardless of tumor size.
- •At least 18 years of age.
- •ECOG performance status ≤ 2
- •Normal bone marrow and organ function as defined below:
- •Leukocytes ≥ 3,000/mcL
- •Absolute neutrophil count ≥ 1,500/mcl
- •Platelets ≥ 100,000/mcl
- •Serum bilirubin within (or under ) normal limits (OR total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
- •AST(SGOT)/ALT(SGPT) within (or under ) normal limits
- •Creatinine clearance ≥ 60 mL/min/1.73 m2
- •Patients may be pre- or post-menopausal. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- •Able to tolerate PET/MRI with intravenous contrast administration and must complete the applicable MRI screening evaluation form
排除标准
- •Prior systemic therapy for the indexed breast cancer.
- •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 bilateral or inflammatory breast cancer.
- •Currently receiving any other investigational agents.
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or carboplatin.
- •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.
- •Pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test within 7 days of study entry if premenopausal.
- •Known HIV-positivity.
- •Sentinel lymph node biopsy
- •Renal insufficiency (glomerular filtration rate (GFR) < 30 mL/min/1.73 m2) measured within the past 60 days which precludes safe administration of the contrast agent
- •On dialysis
- •Prior allergic reaction to gadolinium-based MR contrast agents
研究组 & 干预措施
Washington University: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.
干预措施: Docetaxel (Drug)
Washington University: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.
干预措施: Carboplatin (Drug)
Washington University: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.
干预措施: FDG-PET/MR (Procedure)
Baylor: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
干预措施: Docetaxel (Drug)
Baylor: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
干预措施: Carboplatin (Drug)
Baylor: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
干预措施: FDG-PET/MR (Procedure)
结局指标
主要结局
Pathological Complete Response (pCR) Rate
时间窗: At the time of surgery (surgery will take place 3-5 weeks after completion of treatment and estimated treatment length is 18 weeks)
-A patient is considered to not to have a pCR if any of the following are true: * There is histologic evidence of invasive tumor cells in the surgical breast specimen or the axillary lymph nodes. * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity, or radiographic evidence of progression and then goes straight to surgery where there is histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity or radiographic evidence of progression and then receives alternative treatment. * The patient discontinues study treatment, refuses surgery, or is unable to undergo surgery due to a co-morbid condition. Thus, any patient who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pCR.
次要结局
未报告次要终点