- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00563953
Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years (CAPRICE)
A Phase II, Open-Label, Multicenter Clinical Trial of Pegylated Liposomal Doxorubicin (Caelyx®) as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease or Age Over 65 Years.
연구 개요
상세 설명
This is a phase II, uncontrolled, open label, multicenter study of a primary chemotherapy regimen consisting of four cycles of liposomal pegylated doxorubicine 35 mg/m² IV plus cyclophosphamide 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery in breast cancer patients at risk of developing anthracycline-induced cardiotoxicity.
Surgery (tumorectomy, quadrantectomy, or mastectomy plus lymphadenectomy) will be performed 2 to 5 weeks after the last primary chemotherapy infusion.
Patients with > 10% of hormone receptor-positive cells will receive appropriate hormone therapy according to menopausal status.
Patients treated with breast-conserving surgery will receive radiation therapy to the mammary gland.
Patients with T4 tumors or significant axillary involvement (≥ ypN2) will receive radiation therapy to the breast or chest wall and to the lymph node chains.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Barcelona, 스페인, 08025
- Hospital de la Santa Creu i Sant Pau
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Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron
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Lleida, 스페인, 25198
- Hospital Universitari Arnau de Vilanova
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Madrid, 스페인, 28041
- Hospital Universitario 12 de octubre
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Murcia, 스페인, 30008
- Hospital Universitario Morales Meseguer
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, 스페인, 08907
- Institut Catala d'Oncologia
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Illes Balears
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Palma de Mallorca, Illes Balears, 스페인, 07198
- Hospital Son Llatzer
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Tarragona
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Reus, Tarragona, 스페인, 42301
- Hospital Universitario Sant Joan de Reus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically confirmed invasive breast cancer (tumor > 2 cm).
- Estrogen receptor-negative or -weakly positive tumors (less than 50% of cells), as evaluated using IHC.
- Risk factors for developing anthracycline-induced cardiomyopathy.
Exclusion Criteria:
- Severe heart failure (NYHA Class III or IV) .
- Metastatic disease.
- LVEF < 45%.
- Pregnant or breast-feeding patients.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
Primary chemotherapy regimen consisting of four cycles of pegylated-liposomal doxorubicine at 35 mg/m² IV plus CPM 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
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Four cycles of liposomal pegylated doxorubicine at 35 mg/m² IV combined with cyclophosphamide at 600 mg/m² on Day 1 every 4 weeks, and followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Pathological complete response (pCR). pCR is defined as the absence of invasive cancer in the surgical breast specimen. This definition includes evidence of carcinoma in situ only.
기간: At surgery.
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At surgery.
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2차 결과 측정
결과 측정 |
기간 |
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Clinical response rate (complete plus partial responses). Clinical response will be assessed by imaging using the WHO criteria.
기간: Before and after treatment with paclitaxel.
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Before and after treatment with paclitaxel.
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Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy.
기간: At surgery.
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At surgery.
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Axillary node involvement after primary chemotherapy.
기간: At surgery.
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At surgery.
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Left ventricular ejection fraction measured by echocardiography or MUGA.
기간: At baseline, every 2 doxorubicine cycles and before surgery.
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At baseline, every 2 doxorubicine cycles and before surgery.
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Cardiac sign/symptom questionnaire.
기간: At baseline, every 2 doxorubicine cycles and before surgery.
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At baseline, every 2 doxorubicine cycles and before surgery.
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Relapse-free survival at 5 years after surgery and overall survival at 5 years after study entry.
기간: Until 5 years after surgery.
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Until 5 years after surgery.
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Miguel Gil, MD, Institut Catala d'Oncologia
간행물 및 유용한 링크
일반 간행물
- Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16.
- Gil MJ, Bellet MC, Llombart, Ojeda B, Manso L, Mesia C, Morales S, García-Martinez H, Martínez N, Melé M, Fernández-Ortega A, Baselga J. Pegylated Liposomal Doxorubicin (PLD) as Primary Treatment in Estrogen Receptor (ER) and HER2 Poor Breast Cancer and Risk of Developing Cardiotoxicity or Elderly Patients (pt). Results from the Phase II CAPRICE Study. Cancer Research 71(24 Suppl.): 403s, 2011.(CTRC-AACR San Antonio Breast Cancer Symposium)
- Gil-Gil MJ, Bellet M, Bergamino M, Morales S, Barnadas A, Manso L, Saura C, Fernandez-Ortega A, Garcia-Martinez E, Martinez-Janez N, Mele M, Villagrasa P, Celiz P, Perez Martin X, Ciruelos E, Pernas S. Long-Term Cardiac Safety and Survival Outcomes of Neoadjuvant Pegylated Liposomal Doxorubicin in Elderly Patients or Prone to Cardiotoxicity and Triple Negative Breast Cancer. Final Results of the Multicentre Phase II CAPRICE Study. Front Oncol. 2021 Jul 9;11:645026. doi: 10.3389/fonc.2021.645026. eCollection 2021.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .
유방암에 대한 임상 시험
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
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Liposomal pegylated doxorubicine에 대한 임상 시험
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Hellenic Oncology Research GroupUniversity Hospital of Crete종료됨
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Lipomedix Pharmaceuticals Inc.종료됨
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Tianjin Medical University Second HospitalCSPC Pharmaceutical Group Limited알려지지 않은
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Lipomedix Pharmaceuticals Inc.완전한
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CelgeneGynecologic Oncology Group완전한나팔관암 | 상피성 난소암 | 원발성 복막암미국
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AGO Study GroupEssex Pharma GmbH; MedServ. GmbH, Wiesbaden완전한자궁경부암 | 난소암, 2차 치료제로 치료 | 뮬러리안 혼합 종양 | 자궁 종양 | 비상피성 난소 종양독일