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:
1. What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy? 2. What is the impact of OFS treatment duration on patient prognosis?
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.
Female breast cancer patients who were premenopausal at the time of surgery.
Newly diagnosed patients with invasive breast cancer, tumor node metastasis(TNM) stage I-III.
HR-positive (defined as ER ≥ 10% and/or progesterone receptor(PR) ≥ 10%).
Patients who have undergone radical mastectomy and are planning to receive OFS treatment.
Simultaneously participating in another blinded clinical study.
Presence of other active malignant tumors or multiple primary cancers.
Pregnant or lactating women.
Other conditions that the investigator deems unsuitable for inclusion in the study.
1. Female breast cancer patients who were premenopausal at the time of surgery. 2. Newly diagnosed patients with invasive breast cancer, TNM stage I-III. 3. HR-positive (defined as ER ≥ 10% and/or PR ≥ 10%). 4. Patients who have undergone radical mastectomy and are planning to receive OFS treatment. 5. Have received (neo)adjuvant chemotherapy and radiotherapy. 6. ECOG PS score of 0-1. 7. Complete medical records. 8. Willing to accept long-term follow-up. 9. Any adverse events that occurred during adjuvant chemotherapy (if applicable) have recovered or decreased to grade 1 (according to CTCAE v5.0) at the start of OFS treatment.
Case-only
Prospective
Not listed
Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation.
The proportion of patients who discontinue OFS within 2 years.
Effect of OFS Treatment Duration on Prognosis.
To observe the effect of OFS treatment duration on prognosis.
3-year iDFS for Different OFS Combination Regimens.
3-year iDFS for different OFS combination therapy regimens.
Safety of different combination regimens
The collection and analysis of various adverse events and serious adverse events that occur during different treatment processes.
3-year iDFS of different subgroups
The 3-year invasive disease-free survival (iDFS) for different patient subgroups.
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Zhejiang Cancer Hospital
Lead sponsor
Beijing Health Promotion Association
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
