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| Name | Class |
|---|---|
| Beijing Health Promotion Association | UNKNOWN |
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The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer. The study also aims to understand the compliance with and reasons for discontinuing adjuvant OFS endocrine therapy under different combination regimens.
The main questions it aims to answer are:
Participants, who are already receiving OFS treatment as part of their regular medical care, will have their demographic data, treatment status, clinical outcomes, and adverse events collected over time.
This real-world non-interventional prospective study aims to explore the compliance and reasons for discontinuation of adjuvant OFS endocrine therapy in early HR-positive premenopausal breast cancer patients under different combination regimens of adjuvant endocrine drugs, as well as to observe the impact of the duration of OFS treatment on prognosis. This study adopts a multi-center, prospective, non-interventional design to collect approximately 300 cases of early HR-positive premenopausal breast cancer patients who received OFS treatment. After obtaining informed consent, the demographic data, breast cancer diagnosis information, comorbidities, past medical history, treatment status, clinical outcomes, and adverse events of the patients were collected. The patients were administered medication in accordance with the standard clinical drug protocols and completed follow-up according to the follow-up plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-stage HR-positive premenopausal breast cancer patients receiving OFS treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation. | The proportion of patients who discontinue OFS within 2 years. | Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of OFS Treatment Duration on Prognosis. | To observe the effect of OFS treatment duration on prognosis. | 3-year iDFS rate for OFS treatment duration ≥2 years and <2 years |
| 3-year iDFS for Different OFS Combination Regimens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Yu | Contact | +8613958013303 | yuyangkaiyu@163.com |
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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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3-year iDFS for different OFS combination therapy regimens.
| 3 years. |
| Safety of different combination regimens | The collection and analysis of various adverse events and serious adverse events that occur during different treatment processes. | During the follow-up period, which is every 3 months within the first 2 years, and every 6 months from year 2 to year 3 |
| 3-year iDFS of different subgroups | The 3-year invasive disease-free survival (iDFS) for different patient subgroups. | 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |