To evaluate the efficacy and safety of Disitamab Vedotin combined with Penpulimab as neoadjuvant therapy in patients with HER2-low early or locally advanced breast cancer
Subjects who met the criteria for admission were treated with Disitamab Vedotin(2.0mg/kg,iv,q3w) combined with Penpulimab (200mg,iv,q3w) as neoadjuvant therapy for 6 cycles before surgery, and DCR and ORR were assessed before surgery. All subjects who are suitable for surgery undergo surgery and evaluate their pCR rate (pathological complete remission rate). The postoperative treatment plan was developed according to the subjects' condition and willingness。
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Disitamab Vedotin(RC48):2.0mg/kg, iv, day1, q3weeks, 6 cycles in total;
Penpulimab(AK105):200mg, iv, day1, q3weeks, 6 cycles in total;
West China Hospital, Sichuan University
Chengdu, Chengdu, Sichuan, China, China
Pathological complete response rate (pCR) (ypT0/is N0)
No microscopically detectable remnants of aggressive tumors in breast and axillary lymph nodes, ductal carcinoma in situ is allowed.
Time frame: Immediately after surgery
Objective response rate (ORR)
The percentage of subjects with CR or PR as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of preoperative neoadjuvant therapy (CR+PR)/Analysis of the total number of people.The solid tumor response assessment standard (RECIST 1.1 standard) was used to assess the objective tumor response.
Time frame: Baseline (Before surgery)
Disease Control Rate (DCR)
The percentage of patients with complete remission (CR), partial remission (PR) and stable disease (SD) (≥4 weeks) confirmed by the RECIST 1.1 standard among patients with evaluable efficacy.
Time frame: Baseline (Before surgery)
Complete remission rate of breast pathology (bpCR)
No microscopically detectable remnants of aggressive tumors in breast, ductal carcinoma in situ is allowed
Time frame: Immediately after surgery
Adverse events (AEs)
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE)version 5.0. The type, grade and frequency of AEs will be reported.
Time frame: From screening phase through study completion, an average of 1 year
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