Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine (KNOWHER)
2020년 3월 4일 업데이트: BELEN RUIZ-ANTORAN
Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer
The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program
연구 개요
상태
완전한
정황
상세 설명
This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.
The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.
연구 유형
관찰
등록 (실제)
220
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Madrid, 스페인, 28222
- Puerta de Hierro University Hospital
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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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
This study will include a cohort of approximately 700 adult patients from the Spain with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early access program.
The decision to initiate use of Trastuzumab emtansine (T-DM1) and Pertuzumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.
설명
Inclusion Criteria:
- Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
- Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.
Exclusion Criteria:
- Given the characteristics of the study there are no exclusion criteria.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Pertuzumab
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program
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Trastuzumab emtansine
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall survival.
기간: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
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The time between the date of start of treatment and the date of death.
For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
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Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression free survival.
기간: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
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The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).
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Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
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Best overall response rate
기간: Through study completion, an average of 4 year
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Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record
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Through study completion, an average of 4 year
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Duration of response (DOR)
기간: Through study completion, an average of 4 year
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The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first.
At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.
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Through study completion, an average of 4 year
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Time to treatment failure
기간: Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
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Time to Objective Response
기간: Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
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The time from start of treatment to the date of the first confirmed response (evaluated for responders only)
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Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
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Time to change treatment
기간: Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
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Time to next treatment
기간: Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
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Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
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All suspected Grade 3/4/5 adverse reactions
기간: Through study completion, an average of 4 year
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Through study completion, an average of 4 year
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Adverse events of special interest to anti HER2 Mab (AESI)
기간: Through study completion, an average of 4 year
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Through study completion, an average of 4 year
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AEs of scientific interest
기간: Through study completion, an average of 4 year
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Through study completion, an average of 4 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Belén Ruiz-Antorán, PhD, Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain
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)
2017년 12월 1일
기본 완료 (실제)
2018년 10월 1일
연구 완료 (실제)
2020년 1월 31일
연구 등록 날짜
최초 제출
2017년 1월 11일
QC 기준을 충족하는 최초 제출
2017년 1월 16일
처음 게시됨 (추정)
2017년 1월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 3월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 4일
마지막으로 확인됨
2020년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ML29844
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .