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临床试验/NCT03390608
NCT03390608已完成不适用

Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 35,002 人开始时间: 2018年1月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
35,002
试验地点
1
主要终点
Breast cancer specific death

研究概览

简要总结

Because of mammography screening increasingly more women are diagnosed with centimeter or subcentimeter node-negative breast cancer (i.e., T1abN0); these tumors account for approximately 19% of all newly diagnosed breast cancers in Sweden. Although the long term relapse-free survival rates among patients with such tumors is as high as ≥90%, some reports suggest that certain patient subgroups may have rates <75%. Firmly established prognostic and predictive factors for patients with T1abN0 tumors are, however, lacking. This is a nationwide, register-based cohort study investigating prognostic and predictive factors in women with centimeter or subcentimeter breast cancer. The study hypotheses are: 1) Established prognostic and/or predictive factors in overall breast cancer are prognostic and/or predictive factors also in centimeter or subcentimeter node-negative breast cancer; 2) The established relative reduction in risk of recurrence and death of adjuvant treatment for overall breast cancer are similar in centimeter or subcentimeter node-negative breast cancer.

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
— 至 100 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Operated for centimeter or subcentimeter breast cancer.

排除标准

  • Previous breast cancer.
  • Metastatic breast cancer at diagnosis.

研究组 & 干预措施

Women with T1ab breast cancer.

干预措施: Endocrine therapy (Drug)

Women with T1ab breast cancer.

干预措施: Radiotherapy (Radiation)

Women with T1ab breast cancer.

干预措施: Herceptin (Drug)

Women with T1ab breast cancer.

干预措施: Chemotherapy (Drug)

Women with T1ab breast cancer.

干预措施: Type of breast cancer surgery (Procedure)

Women with T1ab breast cancer.

干预措施: Age at diagnosis (Other)

Women with T1ab breast cancer.

干预措施: Screen detected tumor (Other)

Women with T1ab breast cancer.

干预措施: Menopausal status at diagnosis (Other)

Women with T1ab breast cancer.

干预措施: Tumor size (Other)

Women with T1ab breast cancer.

干预措施: Estrogen receptor (ER) status (Other)

Women with T1ab breast cancer.

干预措施: Tumor grade (Other)

Women with T1ab breast cancer.

干预措施: HER2-status (Other)

Women with T1ab breast cancer.

干预措施: Intrinsic subgroups of breast cancer (Other)

Women with T1ab breast cancer.

干预措施: Nodal status (Other)

结局指标

主要结局

Breast cancer specific death

时间窗: January 1, 1977 to December 31, 2014

次要结局

  • Death from any cause(January 1, 1977 to July 30, 2016)
  • Metachronous breast cancer(January 1, 1977 to July 30, 2016)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Pettersson

Researcher, Principal Investigator

Karolinska Institutet

研究点 (1)

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