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To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.
This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFS continues to use after 5 years | HR-positive premenopausal female patients whose doctors believe that they can benefit from continued use of OFS after 5 years should be included in the trial group. |
| |
| OFS discontinues to use after 5 years | The control group did not need to continue to use OFS, either leuprolide or goserelin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFS continues to use group after 5 years use | Drug | Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| invasive disease-free survival | The main effect evaluation index was invasive disease-free survival (iDFS) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival for years, which means the rate of patients alive in the whole patients at the same group will be calculated with kaplan meier survival curves. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score | Quality of life score was evaluated by European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3 (EORTC-QLQ-C30 V3), which conduct a series of questions about the patients' physical condition, activity of daily life, adverse reaction and mood condition. The range in the questionnaire for the score is from 1 to 4, in which 1 stands for having no discomfort and 4 stands for having great discomfort. |
Inclusion Criteria:
Exclusion Criteria:
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Women who are diagnosed as early breast cancer and have received 5 years treatment of OFS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongmei Zheng, Doctor | Contact | 18971624606 | +86 | zhenghongmeicj@163.com |
| Xinhong Wu, Doctor | Contact | 18602726300 | +86 | wuxinhong_9@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongmei Zheng, Doctor | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wu Xinhong | Recruiting | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Immunohistochemical detection of HR status | Diagnostic Test | Enrolled patients must be HR-positive premenopausal breast cancer patients |
|
| 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |