- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05424835
A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
August 8, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
The study is being conducted to evaluate whether the efficacy of SHR-A1811 is better than Pyrotinib in combination with Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
269
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yima Na
- Phone Number: +86 13524614769
- Email: nayima.bayaxi@hengrui.com
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Recruiting
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
-
Principal Investigator:
- Herui Yao
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Able and willing to provide a written informed consent;
- Unresectable or metastatic HER2 positive breast cancer previously treated with Trastuzumab and Taxane in recurrence and metastasis stage;
- Documented disease progression;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy ≥ 12 weeks.
- Subject has measurable disease based on RECIST v1.1;
- Important organ function can meet the criteria (no blood component and cell growth factor treatment within 14 days before the first study drug administration)
Pregnancy and Contraception:
- Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures and not to lactate from screening until 7 months after receiving the last treatment.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first study drug administration.
Exclusion Criteria:
- Subjects with other malignant tumors in the past 5 years (except for the cured skin basal cell carcinoma and cervical carcinoma in situ).
- There is a third interstitial effusion (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods.
- Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug administration and absorption.
- Received mitomycin C and nitrosoureas chemotherapy within 6 weeks before the first study drug administration.
- Any surgery (eg., major surgery for cancer), radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.
- Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of > 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.
- History of autoimmune disease with the possibility of recurrence or active autoimmune disease; subjects with skin diseases without systematic treatment such as vitiligo, psoriasis, alopecia, or controlled type I diabetes treated with insulin can be included; asthma completely relieved in childhood without any intervention in adult can be included, subjects that requires medical intervention with bronchodilators for asthma cannot be included).
- History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV) or other acquired or congenital immune-deficient disease, or organ transplantation.
- Cardiac disease including myocardial infarction within a minimum 6 months before the first study drug administration, severe or unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] classes ≥II), or clinically significant supraventricular or ventricular cardiac arrhythmia requiring treatment/intervention.
- Subjects with known or suspected interstitiallung disease;
- Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU / ml), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the detection limit of the analytical method), hepatic cirrhosis, or severe infections requiring antibiotic, antiviral or antifungal control.
- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE v5.0 Grade ≤1 at baseline. Subjects with chronic Grade 2 toxicities may be eligible at the discretion of the investigator and discussion with sponsor.
- Known history of severe allergy to study drug or its components, or allergy to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.).
- The presence of other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for study participation by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-A1811
|
SHR-A1811
|
Experimental: Pyrotinib in combination with Capecitabine.
|
Pyrotinib in combination with Capecitabine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFS(BIRC assessment)
Time Frame: 6 weeks after the first study drug administration,about 2 years.
|
6 weeks after the first study drug administration,about 2 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 29, 2022
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
June 15, 2022
First Submitted That Met QC Criteria
June 15, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-A1811-III-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on SHR-A1811
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Henan Cancer HospitalRecruitingHER2 Low Breast CarcinomaChina
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Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Non-small Cell Lung CancerChina
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Shengjing HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruitingER Positive/HER2 Low Breast CancerChina
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Jiangsu HengRui Medicine Co., Ltd.Recruiting
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Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Non-small Cell Lung CancerChina
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Jiangsu HengRui Medicine Co., Ltd.Atridia Pty Ltd.RecruitingAdvanced Solid TumorsChina, Korea, Republic of, Taiwan, United States, Australia
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Jiangsu HengRui Medicine Co., Ltd.Active, not recruitingGastric Cancer | Colorectal CancerChina
-
Fudan UniversityRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingHER2-expressing Advanced Solid TumorsChina
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.Enrolling by invitationAdvanced Solid TumorsChina