Actively Recruiting
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Led by Henan Cancer Hospital · Updated on 2024-11-04
66
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.
CONDITIONS
Official Title
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 70 years old (inclusive)
- Treatment-naive patients with clinically confirmed T2-T3 breast cancer, any nodal status, and no distant metastasis (M0)
- HR-positive, low HER2 expression breast cancer with Ki-67 expression exceeding 14% confirmed by histology or cytology
- ECOG performance status of 0 to 1
- Normal organ and bone marrow function
- Women of childbearing age must agree to use highly effective contraception for 7 months from study start until last medication and agree not to breastfeed
- Voluntary participation with signed informed consent
You will not qualify if you...
- Evidence of metastatic or inflammatory breast cancer
- Previous anti-cancer therapy or radiotherapy for any malignancy, except cured conditions like cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma
- Use of other anti-tumor therapies during the study, including endocrine therapy, bisphosphonates, or immunotherapy
- Major surgery unrelated to breast cancer within 4 weeks before first medication or incomplete recovery from surgery
- Clinically significant pulmonary or cardiovascular disease
- Conditions affecting drug administration or absorption such as failure to swallow, chronic diarrhea, or intestinal obstruction
- Known allergy to study drug or its components
- History of immunodeficiency including HIV or organ transplantation
- Pregnant or breastfeeding women
- Serious concomitant diseases or other conditions interfering with planned treatment or unsuitable for participation as assessed by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
Z
Zhenzhen Liu, Professor
CONTACT
J
Jiujun Zhu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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