IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,295
- 试验地点
- 1
- 主要终点
- Medical treatment
研究概览
简要总结
Relationship between the presence of the BRCA mutation (BReast Cancer) and outcomes is unclear in high-risk early breast cancers (BC).
This study is a multi-center retrospective cohort of patients treated in region Franche-Comté for an early BC by neoadjuvant and/or adjuvant chemotherapy.
The primary aim was to describe clinical and pathological characteristics considering BRCA mutated (BRCAm) patients versus BRCA wild type (BRCAwt) patients or untested patients. The second objective was to assess the prognostic impact of germinal BRCAm in this high-risk population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years old,
- •Histologically confirmed invasive early breast cancer
- •Neo-adjuvant and/or adjuvant chemotherapy with the first cure of chemotherapy received between January 1st, 2003 and December 31th, 2013
排除标准
- •Clinical, radiological or histological confirmed metastatic disease
- •Non-invasive breast cancer,
- •Patients who received incomplete treatment
- •Patients who did not speak French
结局指标
主要结局
Medical treatment
时间窗: one day
Type of chemotherapy (adjuvant, neoadjuvant, metastatic)
Scarff Bloom and Richardson grade (SBR)
时间窗: one day
This grade is the addition of score of tubule formation (\>75% 1 point 10%-75% 2 point \<10% 3 points), nuclear pleomorphism (small, regular uniform cells 1 point moderate increase in size and variability 2 points, marked Variation 3 points) and mitotic counts (dependent on microscope field area 1-3 points) assessed by pathology analysis on tumor after surgery. The SBR grade is ranging from I (total of 3 to 5), II (6 and 7) and III (8 and 9).
Pathological nodal involvement
时间窗: one day
Presence of metastasis on complete lymphadenectomy
HER2 status
时间窗: one day
Expression of HER2 on tumor after surgery (expression assessed by immuno-histo-chemistry, if HER2 is ++, fluorescence in situ hybridization. HER2 status is ranged to not overexpressed (0 and +), equivocal (++) and overexpressed (+++).
Metastatic sites (if available)
时间窗: one day
Metastatic sites of primary breast cancer : Nodal (other than axillary), lung, liver, bone, cerebral and other sites.
Age of diagnosis
时间窗: one day
The date from the date of birth to the date of pathological diagnosis (Years)
Clinical nodal involvement
时间窗: one day
Presence of axillary lymph nodes before surgery (no versus yes)
Pathological histotype
时间窗: one day
Histologic subtype of breast tumor : ductal, lobular or other, assessed by pathology analysis on tumor after complete surgery
Pathological tumor size
时间窗: one day
Pathological tumoral size after partial or complete surgery Pathological size in millimeters after complete surgery
Estrogen receptor expression status
时间窗: one day
Expression of estrogen receptors on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
In situ component
时间窗: one day
Presence or absence of in situ carcinoma assessed by pathology analysis on tumor after surgery
Clinical tumor size
时间窗: one day
Clinical measurement of the tumor in millimeters after surgery
Progesterone receptor expression status
时间窗: one day
Expression of progesterone receptor on tumor after surgery (% expression in immuno-histo-chemistry, ranging from 0 to 100%.
Sexe
时间窗: one day
Male or Female
次要结局
- Overall Survival(one day)
- Invasive Disease Free Survival(one day)
- Distant Disease Free Survival(one day)