- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03367676
소형 결절 음성 HER2 양성 유방암(SOBER) 환자의 12주 보조제 도세탁셀 + 트라스투주마B (SOBER)
12주 종양 ≤1cm, 결절 음성, HER2 양성 유방암(SOBER) 환자의 보조제 도세탁셀 플러스 트라스투주마B: 단일 그룹군, 공개 라벨, 전향적, 2상 연구
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
연구 개요
상세 설명
Many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of HER2 positive early breast cancer with tumor size ≥1cm or node metastasis.But in pT1n0m0 breast cancer patients, patients with HER2 positive tumor show worse prognosis than those with HER2 negative tumor.A short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.Our study aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200025
- Ruijin Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Women aged ≥18 years
Have finished radical operation
Pathologically confirmed dignosis of infiltrating primary breast cancer
According to AJCC ,pT≤1cm, pN0,no evidence for metastasis
Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be Her2 positive tumor (3+ by IHC or FISH+ )
Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1,expected survival time > 12 months
Adequate bone marrow function,adequate liver and renal function,and adequate coagulation function.
Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
Written informed consent according to the local ethics committee requirements.
Exclusion Criteria:
pT>1cm or node positive
Metastatic breast cancer
Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including severe infection, coagulation disorder,active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
Has symptomatic peripheral neuropathy > grade 2 according to NCI
Known severe allergy to any drugs in this study
Has cadiac Dysfunction or lung dysfunction defined as follows:
- grade ≥3 CHF according to NCI CTCAE v 4.0 or NYHA≥II
- angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms
- uncontrolled high-risk arryhthmia
- unconrolled hypertension
Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
Patient is pregnant or breast feeding
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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 |
|---|---|
|
실험적: Experimental Arm
12 weeks adjuvant docetaxel plus trastuzumab |
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles. Docetaxel 100mg/m2,d1,iv,q3w*4 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Disease-free Survival
기간: 3-year estimates
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Disease-free survival is defined as the time from the date of surgery to the first appearance of one of the following: breast cancer in situ or invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up. |
3-year estimates
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Breast Cancer Specific Survival
기간: 3-year estimates
|
Defined as the time from the date of surgery to death from breast cancer relapse; or censored at date last known alive. |
3-year estimates
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Overall Survival
기간: 3-year estimats
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Defined as the time from the date of surgery to death from any cause; or censored at date last known alive. |
3-year estimats
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Treatment-related adverse events
기간: up to 4 months
|
Incidence and severity of adverse events as assessed by NCI CTCAE V4.0 |
up to 4 months
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Change of LVEF after treatment
기간: up to 4 months
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The change of LVEF after 12 weeks treatment compared to the baseline LVEF |
up to 4 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Li Zhu, doctor, Shanghai Jiao Tong University School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RJBC1712
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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