Breast Cancer Clinical Trial
Official title:
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With Hormone Receptor-positive Intraductal Carcinoma of the Breast: A Multicenter, Retrospective, Real-world Study
Verified date | December 2020 |
Source | First Hospital of China Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 medication. This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis, adverse reactions, and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy.
Status | Active, not recruiting |
Enrollment | 1354 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - (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: 1. Histologically confirmed intraductal carcinoma of the breast, accompanied by microinvasion, with the infiltration range = 1 mm; 2. Have received radical resection or breast conserving surgery; 3. 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; 4. No lymph node metastasis (including micrometastasis) is detected by postoperative pathological examination; 5. Immuno 6. 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 Criteria: - (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 |
Country | Name | City | State |
---|---|---|---|
China | The First Hospital of China Medical University | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
First Hospital of China Medical University | Affiliated Hospital of Hebei University of Engineering, China-Japan Union Hospital, Jilin University, First Hospital of Jilin University, Fourth People's Hospital of Shenyang, General Hospital of Benxi Steel & Iron (Group) Co., Ltd, Jilin Provincial Tumor Hospital, Second Hospital of Jilin University, The Affiliated Zhongshan Hospital of Dalian University, The Fifth People's Hospital of Shenyang, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events of endocrine therapy up to 16 years | The incidence, nature, and severity of adverse events (including serious adverse events) | Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years | |
Primary | Disease-free survival up to 16 years | Disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which relevant event occurs. | Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years | |
Primary | Invasive disease-free survival up to 16 years | Invasive disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which intraductal carcinoma of the breast recurs. The recurrent diseases include ipsilateral or contralateral breast cancer, local and distant recurrence of breast cancer, and death due to any reason. | Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years | |
Primary | Distant disease-free survival up to 16 years | Distant disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which distant metastasis occurs. | Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years | |
Secondary | Overall survival up to 16 years | Overall survival refers to the first disease-free day to the time of death caused by any reason. | Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years |
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