SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
NCT ID: NCT05814354
Last Updated: 2023-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
530 participants
INTERVENTIONAL
2023-06-30
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT05424835
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
NCT05635487
SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response
NCT07129187
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
NCT05845138
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
NCT07196774
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SHR-A1811
SHR-A1811
SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.
Physician's Choice
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHR-A1811
SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. HR-positive breast cancer with at least one endocrine therapy and disease progression was judged by the investigator to no longer benefit from endocrine therapy.
3. Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting.
4. Has documented radiologic progression (during or after most recent treatment).
5. Has at least 1 protocol-defined measurable lesion.
6. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions.
7. Fertile women (WOCBP) subjects agreed to use highly effective contraception and not to breastfeed from the time of study screening until 7 months after receiving the last study medication; a fertile woman must have a negative serum pregnancy test result within 7 days prior to the first treatment.
Exclusion Criteria
2. A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
3. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
4. Has moderate or severe cardiovascular disease.
5. Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects.
6. Any other malignancies within 5 years except for those with negligible risk of metastasis or death.
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR-A1811-III-306
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.