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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
SHR-A1811 for injection
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGObjective Response Rate (ORR) Tumours (RECIST) v1.1
Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid
Time frame: During 24 weeks of the neoadjuvant treatment
Incidence of Adverse Events
Evaluate the nature, incidence and severity of SHR-A1811 adverse events according to CTCAE 5.0
Time frame: from consent to 28 days after last dose
Residual cancer burden (RCB)
Residual cancer burden (RCB)
Time frame: At the time of surgery
Pathological complete response
pCR: ypT0/is ypN0
Time frame: At the time of surgery
Event-free survival (EFS)
EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause
Time frame: 5 years
Disease-free survival (DFS)
Disease-free Survival, From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Time frame: 5 years
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