Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
| Second Hospital of Jilin University | OTHER |
| Jilin Provincial Tumor Hospital | OTHER |
| Affiliated Zhongshan Hospital of Dalian University |
Not provided
Not provided
Not provided
Not provided
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.
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 receptor positive ductal carcinoma of the breast. Commonly used drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Exemestane, Anastrozole, Letrozole). Although these drugs can effectively reduce the recurrence and metastasis of ductal carcinoma of the breast, the adverse reactions of the above drugs significantly reduce the quality of life and treatment compliance of the patients. Therefore, the choice of endocrine therapy for intraductal carcinoma of the breast has been widely discussed. Is it possible for de-escalation of endocrine treatment intensity to reduce adverse reactions and improve patient compliance? Recently, a phase 3 clinical trial found that compared with placebo group, the adverse reactions of Tamoxifen group treated with 5 mg/d (conventional dose 20 mg/d) Tamoxifen for 3 years had less adverse reactions and achieved significant efficacy. This study revealed the reliable efficacy and safety of Tamoxifen, a low-dose drug for treatment of hormone receptor positive intraductal carcinoma of the breast. However, little is reported on the reasonable duration of Aromatase inhibitors for endocrine therapy in patients with intraductal carcinoma of the breast.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 20 mg/d, oral administration |
| |
| Toremifene |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
(3)A volunteer to participate in the study and willing to cooperate with follow-up
Exclusion Criteria:
Not provided
patients with hormone receptor-positive ductal carcinoma of the breast
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bo Chen, MD | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012008 | Recurrence |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D017312 | Toremifene |
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
| 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 |
| Shenyang Fifth People's hospital | 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 |
Not provided
Not provided
Not provided
| Drug |
60 mg/d, oral administration |
|
| Anastrozole | Drug | 1 tablet (1 mg) per day, oral administration |
|
| Letrozole | Drug | 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 | Drug | 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. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |