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| Name | Class |
|---|---|
| Cancer Hospital Chinese Academy of Medical Science | UNKNOWN |
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The aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II / III HER-2 positive breast cancer.
Arms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.
Experimental group : Docetaxel or albumin paclitaxel combined with lobaplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab | Other | Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w ) combined with carboplatin ( AUC 5-6 i.v. q3w ) for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. |
|
| Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab | Experimental | Docetaxel ( 75mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260mg / m2 i.v. d1, q3w ) combined with lobaplatin ( 30mg / m2 i.v. q3w ) for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lobaplatin | Drug | 30mg / m2 i.v. q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response | pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive tumor on hematoxylin and eosin evaluation of breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants. | Up to approximately 27-30 weeks |
| Adverse events (AEs) | AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE. The type, grade and frequency of AEs will be reported. | Up to approximately 35 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) in all participants | EFS is defined as the time from start of study treatment to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause. | Up to approximately 5 years |
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Inclusion Criteria:
Adequate function of major organs meets the following requirements:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Wang, MD | Contact | +8613505409989 | wangysh2008@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences | Shandong | Jinan | 250117 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C066228 | lobaplatin |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| carboplatin |
| Drug |
AUC 5-6 i.v. q3w |
|
| Docetaxel or albumin paclitaxel | Drug | Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w ) |
|
| Trastuzumab | Drug | 6 cycles of treatment, according to the instructions recommended dosage. |
|
| pertuzumab | Drug | 6 cycles of treatment, according to the instructions recommended dosage. |
|
| Objective Overall Response Rate (ORR) |
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until definitive surgery or disease progression. |
| Up to approximately 25-30 weeks |
| Disease-free survival ( DFS ) | DFS is defined as the time interval from the first day of disease-free ( i.e., the date of surgery ) to the first recording of related events, including postoperative disease recurrence and metastasis and death from any cause. | Up to approximately 5 years |
| Distant Disease-Free Survival(DDFS) | DDFS is defined as the time interval from the beginning of treatment ( such as surgery, radiotherapy or drug intervention ) to the first occurrence of distant metastasis or death from any cause. | Up to approximately 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |