The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).
A multicenter, randomized, double-blind, positive drug parallel control design was used. The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks). All eligible subjects were randomly divided into experimental group (hs627 treatment group) and control group (pertuzumab) treatment group. After 4 treatment cycles, the subjects arranged surgical treatment, and then conducted the last visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
408
Prior to surgery: trastuzumab, HS627, and docetaxel for 4 cycles (1 cycle = 21 days).
Prior to surgery: trastuzumab, Pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days).
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Percentage of participants achieving Pathological Complete Response (pCR) as Assessed by the Independent Review Committee (IRC)
pCR was defined as ypT0/is According to the American Joint Committee on Cancer Staging System as Assessed by the IRC
Time frame: After surgery (At surgery cycle 4 Days 22-35)(1 cycle = 21 days)
Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Independent Review Committee (IRC)
tpCR was defined as ypT0/is, ypN0 as assessed by an Independent Review Committee (IRC)
Time frame: After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days)
Percentage of Participants With pCR as Assessed by the Local Pathologist
pCR was defined as ypT0/is as assessed by Local Pathologist
Time frame: After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days)
Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Local Pathologist
tpCR was defined as ypT0/is, ypN0 as assessed by Local Pathologist
Time frame: After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days)
Percentage of Participants With an Objective Response
An objective response was defined as the percentage of participants who achieved a complete response or partial response as the best tumor response during the treatment period (that is, during Cycles 1-4 prior to surgery), as determined by the investigator on the basis of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Prior to surgery (Cycle 4 Days 21) (1 cycle = 21 days)
Percentage of Participants with vital signs, physical examination, left ventricular ejection fraction (LVEF), laboratory examination, adverse events (AE) until last visit
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The percentage of participants who experienced at least one vital sign, physical examination, left ventricular ejection fraction (LVEF), laboratory examination, adverse events (AE) during the study is reported here.
Time frame: Last Visit (After surgery 8 days)(After 4 cycles treatment ,After surgery ) (1 cycle = 21 days)