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임상시험 NCT07497386은(는) Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer 2상 150

대상자모집전
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07497386은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer에 대해 진행되며, 2상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 4월 1일부터 가능하며, 150명의 참여자를 모집할 예정입니다. 항서제약이(가) 진행하는 이 연구는 2028년 12월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.
공식 제목

A Randomized, Open-Label, Multicenter Phase II Clinical Study of Different Doses of Trastuzumab Rezetecan for Injection or Trastuzumab Deruxtecan for Injection in the Treatment of Unresectable Locally Recurrent/Metastatic Breast Cancer With HR-Positive and HER2-Low Expression

질환명
Unresectable Locally Recurrent Breast CancerUnresectable Locally Metastatic Breast Cancer
기타 연구 식별자
  • SHR-A1811-217
NCT 번호
NCT07497386
실제 연구 시작일
2026-04
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2028-12
계획된 등록 인원
150
연구종류
중재연구
단계/상
2상
상태
대상자모집전
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Trastuzumab Rezetecan for Injection
Trastuzumab Rezetecan for Injection, different doses.
Trastuzumab Rezetecan for Injection
Trastuzumab Rezetecan for injection.
실험적Trastuzumab Deruxtecan for Injection
Trastuzumab Deruxtecan for Injection
Trastuzumab Deruxtecan for injection.
주요결과변수
결과변수측정값 설명시간 범위
Progression-free survival (PFS).
Every 6 weeks after administration, approximately 14 months.
이차결과변수
결과변수측정값 설명시간 범위
Objective response rate (ORR).
Every 6 weeks after administration, approximately 14 months.
Duration of response (DoR).
Every 6 weeks after administration, approximately 14 months.
Clinical benefit rate (CBR).
Every 6 weeks after administration, approximately 14 months.
Adverse events (AEs).
Graded according to NCI-CTCAE version 5.0.
From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including complete blood count.
From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including urinalysis.
From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including virology screening.
From the first dose administration until 40 days after the last dose administration.
Serum concentrations of Trastuzumab Rezetecan.
Until the end of treatment, approximately 14 months.
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
여성
  1. Female aged 18 to 75 years (inclusive).
  2. Unresectable locally recurrent or metastatic breast cancer.
  3. Prior therapy must meet the following: No prior chemotherapy for recurrent/metastatic disease. Must have received at least one prior line of endocrine therapy for recurrent/metastatic disease with disease progression, and the investigator judges that further benefit from endocrine therapy is not possible.
  4. Documented radiological disease progression (during or after the most recent therapy).
  5. ECOG performance status of 0 or 1.
  6. Life expectancy ≥ 12 weeks.
  7. At least one extracranial measurable lesion as a target lesion according to RECIST v1.1 criteria.
  8. Adequate function of major organs.
  9. Pregnancy and contraception: Women of childbearing potential (WOCBP) must agree to use highly effective contraception from study screening until 7 months after the last dose of study drug and agree not to breastfeed; serum pregnancy test result must be negative within 7 days before the first dose.
  10. The patient voluntarily participates in this study, signs the informed consent form, has good compliance, and is willing to cooperate with visits and study-related procedures.

  1. Presence of leptomeningeal metastasis/carcinomatous meningitis, spinal cord compression, or active central nervous system metastases.
  2. Patients with only skin or brain lesions as target lesions.
  3. History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  4. Presence of carcinomatous lymphangitis, or third-space fluid accumulation that cannot be controlled by methods such as drainage.
  5. Prior surgery, chemotherapy, immunotherapy, or macromolecular targeted therapy within 4 weeks before the first dose; prior endocrine therapy, chemotherapy with 5-FU analogs, or radiotherapy within 2 weeks before the first dose; small molecule targeted agents require a washout period of 2 weeks or 5 half-lives; other investigational drugs require a washout period of 4 weeks or 5 half-lives before the first dose.
  6. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 2 weeks before the first dose for therapeutic intent.
  7. History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
  8. Clinically significant cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure, etc.; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; myocardial infarction or cerebrovascular accident within 6 months before the first dose.
  9. Participants with known or suspected interstitial lung disease; other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function within 3 months before the first dose; and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement.
  10. Known hereditary or acquired bleeding tendency.
  11. Active hepatitis B, hepatitis C, or cirrhosis; or severe infection requiring control with antibiotics, antivirals, or antifungals.
  12. Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 (according to NCI-CTCAE v5.0).
  13. Any other severe physical or mental illness or laboratory abnormality that may increase the risk associated with study participation, interfere with study results, or any other condition for which the investigator considers the patient unsuitable for participation in this study.
Jiangsu HengRui Medicine Co., Ltd. logo항서제약143개의 진행 중인 임상시험 탐색 가능
연구 대표 연락처
연락처: Xia Zhang, +86-0518-82342973, [email protected]
1 1개국에 임상시험 장소

Beijing Municipality

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, 100021, China
Binghe Xu, 연락처, +86-010-67781331, [email protected]
Binghe Xu, 책임연구자