NCT03437837已完成不适用
Validation of CPS+EG, Neo-Bioscore and Modified Neo-Bioscore Staging System After Preoperative Systemic Therapy of Breast Cancer in Multi-center in China
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,077
- 试验地点
- 12
- 主要终点
- Disease Specific Survival (DSS)
研究概览
简要总结
Prognostic assessment after preoperative systemic therapy (PST) plays a vital role in breast cancer patients. The clinical-pathologic staging system incorporating estrogen receptor (ER)-negative disease and nuclear grade 3 tumor pathology (CPS+EG staging system) can effectively predict prognosis after PST. The Neo-Bioscore has been developed by the incorporation of the human epidermal growth factor receptor 2 (HER2) status into the CPS+EG staging system. But in a real world in China, the both staging systems had limits because of trastuzumab administration varied a lot in China from the United States. This retrospective study will validate CPS+EG and Neo-Bioscore system and explored a modified Neo-Bioscore system in multiple centers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:
- •Has operable, histologically confirmed, Stage I, IIA, IIB, IIIA, IIIB or IIIC invasive carcinoma of the breast.
- •Has had neoadjuvant chemotherapy before operation for this breast cancer.
- •Age >=18 to <=75 years old.
- •Has known ER and PR status.
- •Has known HER-2 status.
- •Has known menopausal status.
- •Before PST, Lymph nodes were evaluated by fine needle biopsy (FNB) if the clinically positive, or by sentinel lymph nodes biopsy (SLNB) if the clinically or FNB negative.
- •Has complete surgical resection of the primary breast tumor after PST: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS).
- •Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Has laboratory values of
- •White blood cell count >3000/mm3
- •Absolute neutrophil count (ANC) ≥1500/mm3
- •Hemoglobin ≥9.0 g/dL
- •Total bilirubin <ULN
- •Serum creatinine ≤1.5 mg/dL
- •Platelet count ≥100,000/mm3
- •ULN = upper limit of normal
- •Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within any of the ranges shown below:
- •ALP ≤ upper limits of normal(ULN),and AST or ALT ≤ 5 ULN
- •ULN < ALP ≤2.5 ULN, and AST or ALT ≤ 1.5 ULN
- •2.5 ULN < ALP ≤5 ULN, and AST or ALT ≤ ULN
- •Has normal cardiac function as evidenced by an left ventricular ejection fraction (LVEF) >50% by echocardiogram (ECHO), Ejection fraction as determined by ECHO must be within normal limits (WNL) by institutional standard.
- •Has no evidence of metastatic disease outside of breast by physical examination and chest x-ray or computed tomography (CT) scan. Other scans if done as needed by the patient [e.g., bone scan; abdominal, chest CT; Positron Emission Tomography (PET) or Positron Emission Tomography-Computed Tomography (PET-CT); ultrasound; or Magnetic Resonance Imaging (MRI)] should indicate no evidence of metastatic disease.
- •Has had baseline bilateral B-type ultrasound，MRI was recommended, but not essential.
- •If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive only) to avoid pregnancy duration the study and for a period of 3 months thereafter
排除标准
- •A patient will be excluded from this study if she meets any of the following criteria:
- •Has bilateral synchronous breast cancer.
- •Has any evidence of metastatic disease: staging work-up, biopsy or physical examination suspicious for malignant disease.
- •Has a history of severe hypersensitivity reaction to chemotherapy drugs or formulation.
- •Has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes.
- •Has peripheral neuropathy >Grade
- •Has had a major organ allograft or condition requiring chronic immunosuppression (ie, kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who have received corneal transplants or cadaver skin or bone transplants are eligible.
- •Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral [including clinically defined acquired immune deficiency syndrome (AIDS)], bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or central nervous system (CNS) disorders deemed by the Treating Physician to be clinically significant, precluding informed consent.
- •Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be human immunodeficiency virus (HIV) positive.
- •Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix, DCIS), which could affect the diagnosis or assessment of any of the study drugs.
- •Is deemed unable to comply with requirements of study.
结局指标
主要结局
Disease Specific Survival (DSS)
时间窗: 5 years
DSS will be calculated from the time of diagnosis to death resulting from breast cancer. Patients still alive at the time of the analysis will be censored using the date they were last known to be alive.
次要结局
- Overall Survival (OS)(5 years)
- Disease-free survival (DFS)(5 years)
研究者
XU Ling
Associate Chief Physician of Breast Disease Center, Associate Professor, M.D.
Peking University First Hospital
研究点 (12)
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