The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are: * Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment? * Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer. Subjects will be randomly assigned 1:1:1 to: * cohort 1:SHR-A1811 combined with pertuzumab for 6 cycles; * cohort 2:SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles; * cohort 3:TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
an anti-HER2 antibody-drug conjugate (ADC)
Pertuzumab
Nab paclitaxel
Docetaxel
Carboplatin
Trastuzumab
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGPathological complete response rate (pCR rate)
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
Time frame: After surgery(within 1 month)
Invasive Disease Free Survival of 5 years
5-year Invasive Disease-Free Survival was defined as patients who did not experience regional, contralateral or distant recurrence, or dies during a follow-up period of at least 5 years from the date of surgery.
Time frame: 5-year
Event-Free Survival of 5 years
5-year Event-Free Survival was defined as patients who did not experience disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or dies during a follow-up period of at least 5 years after treatment.
Time frame: 5-year
Objective Response Rate (ORR)
ORR is the proportion of patients whose tumors have shrunk significantly over the course of treatment. Specifically, ORR includes both partial response (PR) and complete response (CR). Partial response (PR) : The maximum diameter or volume of the tumor is reduced by at least 30%, but it does not completely disappear. Complete response (CR) : The tumor disappears completely and no visible signs of cancer are confirmed by imaging tests, such as CT scans, MRI, or ultrasound.
Time frame: During neoadjuvant therapy before surgery(within 6 months)
Adverse Events rate
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Time frame: 2-year
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