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Trial Title:
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
NCT ID:
NCT05911958
Condition:
HER2 Low Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811 for injection
Description:
SHR-A1811 for injection
Arm group label:
SHR-A1811
Other name:
SHR-A1811 group
Summary:
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.
Detailed description:
This prospective, single-arm study is being conducted to evaluate the efficacy and safety
of SHR-A1811 for early-stage or locally advanced breast cancer patients with HR-Positive,
Low HER2 Expression. Subjects will receive the neoadjuvant therapy of SHR-A1811 for eight
cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. The follow-up
visit will last for at least 5 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients aged 18 to 70 years old (inclusive);
2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast
cancer confirmed by histology or cytology;
4. ECOG performance status of 0-1;
5. Normal organ and bone marrow function;
6. Patients of childbearing age must consent to use highly effective contraception for
7 months from the start of study screening until the last study medication and agree
not to breastfeeding;
7. Patients voluntarily joined the study and signed informed consent;
Exclusion Criteria:
1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;
2. Patients previously received antineoplastic therapy or radiotherapy for any
malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal
cell carcinoma, or squamous carcinoma;
3. Patients received any other anti-tumor therapy at the same time, including endocrine
therapy, bisphosphonates or immunotherapy;
4. Patients have major surgical procedures unrelated to breast cancer within 4 weeks
before the first medication, or not fully recovered from surgical procedures;
5. Clinically significant pulmonary or cardiovascular disease;
6. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other
factors affecting drug administration and absorption;
7. Known to be allergic to any study drug or any of its excipients;
8. History of immunodeficiency, including HIV-positive, or other acquired or congenital
immunodeficiency diseases, or history of organ transplantation;
9. Pregnant and lactating women;
10. Patients with serious concomitant diseases or other comorbidities that will
interfere with the planned treatment, or any other condition that is not suitable
for participation assessed by investigator.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiao DeChuang
Phone:
13598004327
Email:
jiaodechuang1982@163.com
Start date:
July 5, 2023
Completion date:
May 31, 2029
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911958
