Status:
UNKNOWN
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast
Lead Sponsor:
First Hospital of China Medical University
Collaborating Sponsors:
The First Hospital of Jilin University
Second Hospital of Jilin University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-85 years
Brief Summary
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast, and the optimal duration of ...
Detailed Description
Intraductal carcinoma of the breast accounts for 20% of newly diagnosed breast cancer. In addition to necessary surgical treatment, 5-year endocrine therapy is also essential for patients with hormone...
Eligibility Criteria
Inclusion
- (1)Female patients aged ≥ 18 years and ≤ 85 years
- (2)The primary lesions and lymph nodes of the breast must meet all of the following conditions:
- Histologically confirmed intraductal carcinoma of the breast, accompanied by microinvasion, with the infiltration range ≤ 1 mm;
- Have received radical resection or breast conserving surgery;
- Patients who have received breast conserving surgery must undergo pathological examination to confirm there is no residual cancer tissue on the cutting edge and receive postoperative radiotherapy within the prescribed dose and range;
- No lymph node metastasis (including micrometastasis) is detected by postoperative pathological examination;
- Immuno
- Immunohistochemical staining results are positive for estrogen receptor (ER) or progesterone receptor (PR), which is defined as ER or PR immunoreactivity intensity ≥1+ or expression percentage ≥ 1%.
- (3)A volunteer to participate in the study and willing to cooperate with follow-up
Exclusion
- (1)Patients with newly diagnosed metastatic breast cancer or other malignant tumors without breast intraductal carcinoma;
- (2) Patients who have other malignant tumors before the initial diagnosis of intraductal carcinoma of the breast
- (3) Patients who have received endocrine therapy with drugs including Toremifene, Tamoxifen, Anastrozole, Letrozole or Exemestane before the initial diagnosis of intraductal carcinoma of the breast
- (4) Patients who have a serious comorbidity or other comorbidities that interfere with the conduct of the study, or those who are considered not suitable for participation in this study
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 15 2021
Estimated Enrollment :
1354 Patients enrolled
Trial Details
Trial ID
NCT04666805
Start Date
July 1 2020
End Date
January 15 2021
Last Update
December 14 2020
Active Locations (1)
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1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001