Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab + HS627 + Docetaxel | Experimental | Trastuzumab HS627 Docetaxel |
|
| Trastuzumab + Pertuzumab + Docetaxel | Experimental | Trastuzumab Pertuzumab Docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS627 | Drug | Prior to surgery: trastuzumab, HS627, and docetaxel for 4 cycles (1 cycle = 21 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After surgery (At surgery cycle 4 Days 22-35)(1 cycle = 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days) |
| Percentage of Participants With pCR as Assessed by the Local Pathologist |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zefei Jiang, M.D | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Haibo Wang, M.D | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pertuzumab | Drug | Prior to surgery: trastuzumab, Pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days). |
|
|
pCR was defined as ypT0/is as assessed by Local Pathologist |
| 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 | 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. | 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 | 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. | Last Visit (After surgery 8 days)(After 4 cycles treatment ,After surgery ) (1 cycle = 21 days) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |