Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast
NCT ID: NCT04666805
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1354 participants
OBSERVATIONAL
2020-07-01
2021-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Drug Group
Endocrine therapy drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Anastrozole, Letrozole, Exemestane), which have been widely used in the adjuvant treatment of hormone receptor positive breast cancer.
Tamoxifen
20 mg/d, oral administration
Toremifene
60 mg/d, oral administration
Anastrozole
1 tablet (1 mg) per day, oral administration
Letrozole
Adjuvant therapy with letrozole for 5 years or until the disease relapses. Patients who have received tamoxifen adjuvant therapy for 5 years should continue to take Letrozole until the disease relapses. The recommended dose of Letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals. For patients with advanced breast cancer, treatment with Letrozole should continue until tumor progression is confirmed. Patients with liver and/or renal dysfunction (creatinine clearance rate ≥ 10 mL/min) do not need to adjust the dosage.
Exemestane
The recommended dose of Exemestane for adult and older patients with early and advanced breast cancer is one 25 mg tablet administered orally once a day after a meal. After 2-3 years of tamoxifen treatment, patients with early breast cancer should continue to use Tamoxifen in the case of no recurrence or contralateral breast cancer, until the completion of 5-year sequential adjuvant therapy with tamoxifen and exemestane. Patients with advanced breast cancer should continue to take Exemestane until the tumor progresses.
Interventions
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Tamoxifen
20 mg/d, oral administration
Toremifene
60 mg/d, oral administration
Anastrozole
1 tablet (1 mg) per day, oral administration
Letrozole
Adjuvant therapy with letrozole for 5 years or until the disease relapses. Patients who have received tamoxifen adjuvant therapy for 5 years should continue to take Letrozole until the disease relapses. The recommended dose of Letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals. For patients with advanced breast cancer, treatment with Letrozole should continue until tumor progression is confirmed. Patients with liver and/or renal dysfunction (creatinine clearance rate ≥ 10 mL/min) do not need to adjust the dosage.
Exemestane
The recommended dose of Exemestane for adult and older patients with early and advanced breast cancer is one 25 mg tablet administered orally once a day after a meal. After 2-3 years of tamoxifen treatment, patients with early breast cancer should continue to use Tamoxifen in the case of no recurrence or contralateral breast cancer, until the completion of 5-year sequential adjuvant therapy with tamoxifen and exemestane. Patients with advanced breast cancer should continue to take Exemestane until the tumor progresses.
Eligibility Criteria
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Inclusion Criteria
* (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
* (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
18 Years
85 Years
FEMALE
No
Sponsors
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The First Hospital of Jilin University
OTHER
Second Hospital of Jilin University
OTHER
Jilin Provincial Tumor Hospital
OTHER
Affiliated Zhongshan Hospital of Dalian University
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
China-Japan Union Hospital, Jilin University
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
The Fifth People's Hospital of Shenyang
UNKNOWN
General Hospital of Benxi Steel & Iron (Group) Co., Ltd
UNKNOWN
Affiliated Hospital of Hebei University of Engineering
UNKNOWN
Fourth People's Hospital of Shenyang
OTHER
First Hospital of China Medical University
OTHER
Responsible Party
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Bo Chen
Professor
Principal Investigators
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Bo Chen, MD
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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The First Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Other Identifiers
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FirstHCMU_CB_001
Identifier Type: -
Identifier Source: org_study_id