NCT00994968Unknown2 期
Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Rate of pathologic complete response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, docetaxel, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying giving doxorubicin hydrochloride together with cyclophosphamide, docetaxel, and S-1 before surgery in treating women with stage II or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the rate of pathologic complete response in women with previously untreated stage II or III breast cancer treated with neoadjuvant doxorubicin hydrochloride and cyclophosphamide followed by docetaxel and S1.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
- Determine the rate of overall radiologic response in these patients.
- Determine the rate of breast-conserving procedures in these patients.
- Determine the disease-free survival of these patients.
- Investigate the relevant pharmacogenomics and biomarker(s) which will be useful to predict any responses to the anticancer treatments.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed invasive primary breast cancer
- •Clinical (radiologic) stage II or III disease
- •No T4d disease
- •No inflammatory breast cancer
- •ErbB2-negative disease OR patient cannot receive trastuzumab treatment
- •ErbB2-positive disease defined as either immunohistochemistry 3+, or FISH- or CISH-positive; immunohistochemistry 2+ is to be determined according to FISH or CISH results
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Normal cardiac function (LVEF > 50%)
- •Hemoglobin ≥ 10.0 g/dL
- •Absolute neutrophil count ≥ 1,500/μL
- •Platelet count ≥ 10 x 10^4/μL
- •Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
- •Total bilirubin ≤ 1.5 times ULN
- •AST/ALT ≤ 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to swallow tablet whole with water
- •No prior motor or sensory neurotoxicity CTCAE ≥ grade 2
- •No other serious disease or medical condition
- •No uncontrolled or serious cardiovascular disease, including any of the following:
- •Myocardial infarction within the past 6 months
- •New York Heart Association class III or IV heart failure
- •Uncontrolled angina pectoris
- •Clinically significant pericardial disease
- •Cardiac amyloidosis
- •No history of symptomatic or therapy-requiring cardiac arrhythmia CTCAE grade 3 (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation)
- •No asymptomatic sustained ventricular tachycardia
- •History of atrial fibrillation or cardiac arrhythmia controlled by medication allowed
- •No uncontrolled infection, unstable peptic ulcer, uncontrolled diabetes, or any other contraindication to corticosteroid administration
- •No history of infection or any other serious medical event which may cause any functional injury in the affected patient and consequently, interfere with continuing the study treatment
- •No history of hypersensitivity to taxanes, fluorouracil, or S-1
- •No significant gastrointestinal malfunction that will affect S-1 absorption
- •No history of other cancer within the past 5 years except properly treated carcinoma in situ of the uterine cervix or basal cell or squamous cell carcinoma of the skin
- •No severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
- •No psychological, social, family, or geographical condition, or difficult circumstance that would preclude follow-up or compliance with the protocol
- •PRIOR CONCURRENT THERAPY:
- •No prior systemic treatment for this cancer (e.g., radiotherapy, chemotherapy, hormone therapy, or biological therapy)
- •No prior preoperative topical treatments (e.g., incomplete surgery or radiotherapy) for this cancer
- •No concurrent drug(s) that may potentially cause changes in the pharmacological activity of S-1 formulation, including any of the following:
- •Allopurinol
- •Phenytoin
排除标准
- 未提供
结局指标
主要结局
Rate of pathologic complete response
次要结局
- Safety and tolerability
- Rate of overall radiologic response
- Rate of breast-conserving procedure
- Disease-free survival
- Relevant pharmacogenomics and biomarker(s) which may be useful to predict any responses to the anticancer treatments
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Chemotherapy & Bevacizumab for Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-Negative Stage II/III Breast CancerHER2-negative Breast CancerStage IIIC Breast CancerStage II Breast CancerStage IIIB Breast CancerStage IIIA Breast CancerNCT00679029University of Nebraska15
终止
2 期
Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone SarcomaSarcomaNCT00544778City of Hope Medical Center7
已完成
3 期
Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer PatientsBreast CancerNCT01099436Borstkanker Onderzoek Groep250
已完成
2 期
Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast CancerBreast CancerNCT00379015Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan38
Unknown
2 期
Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by SurgeryBreast CancerNCT00801411National Cancer Centre, Singapore318