Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- pCR Rate After Treatment.
研究概览
简要总结
This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is inflammatory or has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
详细描述
PRIMARY OBJECTIVES:
I. To test the hypothesis that carboplatin + nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) therapy will demonstrate a promising neoadjuvant pathologic complete response (pCR) rate for eligible patients.
II. To test the hypothesis that carboplatin + nab-paclitaxel therapy will demonstrate a promising Symmans 0-1 pathological response rate for eligible patients.
SECONDARY OBJECTIVES:
I To evaluate the overall survival and event-free survival of eligible patients treated with carboplatin + nab-paclitaxel neoadjuvant chemotherapy.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be diagnosed with locally advanced (T2 and higher with or without lymph node involvement), and/or inflammatory triple negative breast cancer
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- •Tumor negative for expression of hormone receptors (< 10%) and not over-expressing HER2 by immunohistochemistry (IHC) (0-1), or in case of IHC of 2, negative by fluorescence in situ hybridization (FISH) or by alternative gene testing
- •Bilirubin =< 1.5 mg/dL
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x upper limit of normal
- •Alkaline phosphatase =< 2 x upper limit of normal
- •Platelets >= 100,000 cells/mm^3
- •Hemoglobin > 9.0 g/dL
- •Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
- •Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable
- •Left ventricular ejection fraction > 50%
- •Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
- •Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test screening for patients of childbearing potential
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
- •No prior therapies are allowed for the treatment of the newly diagnosed breast cancer; patients with a prior diagnosis of malignancy treated >= 5 years ago are eligible, provided that they have not received prior taxanes or carboplatin as part of their prior treatment regimen, and that they meet all eligibility criteria
排除标准
- •Known active hepatitis B or C
- •Known active human immunodeficiency virus (HIV)
- •Prior breast cancer or other invasive malignancy treated within 5 years
- •Pregnancy
- •Neuropathy > grade 1
- •Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/primary investigator (PI)
- •Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
研究组 & 干预措施
Treatment (carboplatin and nab-paclitaxel)
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: carboplatin (Drug)
Treatment (carboplatin and nab-paclitaxel)
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: paclitaxel albumin-stabilized nanoparticle formulation (Drug)
Treatment (carboplatin and nab-paclitaxel)
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
pCR Rate After Treatment.
时间窗: At completion of definitive surgery, up to six months from initial treatment
pCR is RCB 0 by Symmans criteria. The goal of the study is a detection of an increase in rate of pathological complete remission (pCR) from 20% (historical) to 38%
Residual Cancer Burden (RCB) by Symmans Criteria.
时间窗: At completion of definitive surgery, up to six months post-commencement of study chemotherapy.
Categorization of the outcome of the treatment at completion of definitive surgery by Symmans criteria. "The index score is derived from the largest area and cellularity of residual invasive primary cancer and the number of involved lymph nodes and size of largest metastasis. pCR (stage yp-T0/is, ypN0) has RCB = 0; and RCB class is minimal (RCB-I), moderate (RCB-II), or extensive (RCB-III), on the basis of predefined cut points of 1.36 and 3.28 index scores.) Symmans WF, Wei C, Gould R, et al. J Clin Oncol 35:1049-1060, 2017. Symmans WF, Peintinger F, Hatzis C et al. J Clin Oncol 25:4414-4422, 2007. Order of scale is RCB0 is best, then I, II, III, worse; progressive is the worst.
次要结局
- Adjuvant Radiation(Up to 6 months)
- Scope of Surgery(Up to 6 months.)
- Overall Survival(Up to three years post-commencement of chemotherapy.)
- Progression-free Survival(Up to three years.)