PG2 Breast Cancer Evaluation in Adjuvant Medicine-Survival Study (PG2 BEAM-S)
Retrospective Survival Follow-up of Stage II/II Breast Cancer Patients Receiving PG2 Combination With Adjuvant Chemotherapy
Astragalus polysaccharides (APS), acting as an immunomodulator, is known to modulate the tumor microenvironment and inhibit tumor growth and progression, thereby suggesting potential as an adjuvant cancer therapy to improve treatment outcomes.
PG2 (APS Injection) has completed a clinical trial (Protocol name: PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance with Chemotherapy among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy , NCT03314805, hereinafter called the parent trial) aimed to show that PG2 treatment among stage II/III breast patients under adjuvant Epirubicin and cyclophosphamide (EC) regimen in reduction of chemotherapy-induced toxicities and encouraging compliance with chemotherapy. This study will further explore whether the addition of PG2 can delay cancer recurrence or metastasis, thereby conferring substantial survival benefits for early breast cancer patients with adjuvant chemotherapy by retrospectively collecting recurrence, metastasis, and survival information from patients enrolled in the parent trial.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Kaohsiung City、台湾
- Chang Gung Memorial Hospital, Kaohsiung Branch
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Kaohsiung City、台湾
- E-Da Cancer Hospital
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Keelung、台湾
- Chang Gung Memorial Hospital, Lovers Lake branch
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Taipei、台湾
- Chang Gung Memorial Hospital, Taipei Branch
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Taoyuan City、台湾
- Chang Gung Memorial Hospital, Linkou Branch
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Patients who were previously enrolled in the [PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance with Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy/NCT03314805] study.
Exclusion Criteria:
- Non
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Treatment
Astragalus polysaccharides 500 mg
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Adjuvant chemotherapy in combination with PG2
其他名称：
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Control
Placebo
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Adjuvant chemotherapy in combination with Placebo
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Distant metastasis-free survival
大体时间：from random assignment to Aug 27, 2025
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Time from random assignment to any first event of distant recurrence, death from any cause, or second (non-breast) invasive cancer.
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from random assignment to Aug 27, 2025
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Disease-free survival
大体时间：from random assignment to Aug 27, 2025
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Time from random assignment to any first event of invasive ipsilateral or contralateral breast recurrence, local or regional invasive recurrence, distant recurrence, second (non-breast) invasive cancer, or death from any cause.
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from random assignment to Aug 27, 2025
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Overall Survival
大体时间：from random assignment to Aug 27, 2025
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Time from random assignment until death from any cause.
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from random assignment to Aug 27, 2025
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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