A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
NCT ID: NCT05635487
Last Updated: 2024-07-05
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
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RECRUITING
PHASE2
65 participants
INTERVENTIONAL
2023-03-16
2030-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SHR-A1811+Pyrotinib
SHR-A1811
SHR-A1811
Pyrotinib
Pyrotinib
SHR-A1811
SHR-A1811
SHR-A1811
Interventions
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SHR-A1811
SHR-A1811
Pyrotinib
Pyrotinib
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed to be HER2-positive invasive breast cancer
* Treatment-naive patients with stage II-III
* Eastern Cooperative Oncology Group (ECOG) score 0-1
* Good level of organ function
Exclusion Criteria
* Received any other anti-tumor therapy at the same time
* Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
* Stage IV breast cancer
* With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
* Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption
* Participated in other drug clinical trials within 4 weeks before enrollment
* History of allergies to the drug components of this protocol
* Clinically significant pulmonary diseases
* Clinically significant cardiovascular diseases
* History of immunodeficiency
* Active hepatitis and liver cirrhosis
18 Years
75 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Shengjing Hospital
OTHER
Responsible Party
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Caigang Liu
Director of the Cancer Center
Principal Investigators
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Caigang Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Shengjing Hospital
Locations
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Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Nan Niu, MD
Role: primary
Other Identifiers
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MUKDEN 07
Identifier Type: -
Identifier Source: org_study_id
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