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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Kaohsiung City, 대만
- Chang Gung Memorial Hospital, Kaohsiung Branch
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Kaohsiung City, 대만
- E-Da Cancer Hospital
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Keelung, 대만
- Chang Gung Memorial Hospital, Lovers Lake branch
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Taipei, 대만
- Chang Gung Memorial Hospital, Taipei Branch
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Taoyuan City, 대만
- Chang Gung Memorial Hospital, Linkou Branch
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Treatment
Astragalus polysaccharides 500 mg
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Adjuvant chemotherapy in combination with PG2
다른 이름들:
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Control
Placebo
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Adjuvant chemotherapy in combination with Placebo
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distant metastasis-free survival
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disease-free survival
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Astragalus polysaccharides 500 mg에 대한 임상 시험
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Azienda di Servizi alla Persona di Pavia아직 모집하지 않음
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Jacob Pontoppidan ThyssenThe Novo Nordic Foundation모병
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Myungmoon Pharma. Co. Ltd.모병
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GEN İlaç ve Sağlık Ürünleri A.Ş.Sulfateq B.V.모병
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Institut für Klinische Krebsforschung IKF GmbH...Servier Deutschland GmbH; Servier Affaires Médicales모병
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Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI); American Lung Association완전한
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Christian Medical College and Hospital, Ludhiana...Indian Council of Medical Research; All India Institute of Medical Sciences, Bhubaneswar; Christian Medical College, Vellore, India 그리고 다른 협력자들모병