Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) (STOP)
2017년 5월 18일 업데이트: Merck Sharp & Dohme LLC
Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)
The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.
연구 개요
상세 설명
Breast cancer is the second most common cause of brain metastases.
Overall survival after the development of brain metastases tends to be poor (6-8 months).
Over-expression of Human Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk for brain metastases.
Temozolomide may be a good candidate for prophylactic chemotherapy because of its ability to cross the blood-brain-barrier, achieving high concentrations in the central nervous system (CNS).
연구 유형
중재적
등록 (실제)
6
단계
- 2 단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Diagnosis of metastatic breast cancer.
- Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.
- No clinical sign of brain progression.
- At least one of the following 3 conditions: HER2 +++, Young age (< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy ≥3 months.
- Neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10^9/L.
- Bilirubin level either normal or <1.5 x ULN (upper limit of normal).
- AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
- Serum creatine <1.5 x ULN.
- Effective contraception if the risk of conception exists.
Exclusion Criteria:
- Concurrent chronic systemic immune therapy not indicated in the study protocol.
- Any investigational agent(s) within 4 weeks prior to entry.
- Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
- Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
- Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
- Known drug abuse/alcohol abuse.
- Legal incapacity or limited legal capacity.
- Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
- Women who are pregnant or breastfeeding.
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 테모졸로마이드
|
Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
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간섭 없음: 관찰
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percent of Participants With Recurrence of Brain Metastases
기간: 1 Year
|
The analysis could not be performed due to low enrollment.
|
1 Year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Days With Progression-free Survival (PFS)
기간: 24, 38, and 52 weeks
|
PFS was defined as the time interval from randomization to objective tumor progression or death from any cause. The analysis could not be performed due to low enrollment. |
24, 38, and 52 weeks
|
|
Number of Days With Disease-free Survival (DFS)
기간: 24, 38, and 52 weeks
|
DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant). The analysis could not be performed due to low enrollment. |
24, 38, and 52 weeks
|
|
Number of Days With Distant Disease-free Survival (DDFS)
기간: 24, 38, and 52 weeks
|
DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain). The analysis could not be performed due to low enrollment. |
24, 38, and 52 weeks
|
|
Number of Days With Brain Recurrence-free Survival (BRFS)
기간: 24,38, and 52 weeks
|
BRFS was defined as the time interval from randomization to the appearance of brain metastases. The analysis could not be performed due to low enrollment. |
24,38, and 52 weeks
|
|
Number of Days on Temozolomide Treatment
기간: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
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Total Dose of Temozolomide Taken
기간: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
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Number of Participants Who Had at Least One Dose Reduction During Treatment
기간: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
|
Number of Participants Who Had at Least One Treatment Omission During Treatment
기간: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
|
Number of Participants Who Completed the Third Cycle of Treatment
기간: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2008년 10월 2일
기본 완료 (실제)
2010년 6월 30일
연구 완료 (실제)
2010년 6월 30일
연구 등록 날짜
최초 제출
2008년 1월 10일
QC 기준을 충족하는 최초 제출
2008년 3월 18일
처음 게시됨 (추정)
2008년 3월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 6월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 18일
마지막으로 확인됨
2017년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P05225
- 2007-005491-14 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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