A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for HR+ Premenopausal Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation.
研究概览
简要总结
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:
- What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy?
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Have received (neo)adjuvant chemotherapy and radiotherapy.
- •Eastern Cooperative Oncology Group Performance Status(ECOG PS) score of 0-
- •Complete medical records.
- •Willing to accept long-term follow-up.
- •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.
排除标准
- •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.
- •Planning to use systemic therapies not described in the study cohort during the endocrine therapy phase (such as, but not limited to, chemotherapy, Antibody-Drug Conjugates(ADCs), or immunotherapy).
结局指标
主要结局
Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation.
时间窗: Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy.
The proportion of patients who discontinue OFS within 2 years.
次要结局
- 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.(3 years.)
- Safety of different combination regimens(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(3 years)
研究者
Yu Yang
MD
Zhejiang Cancer Hospital