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.
Newly diagnosed breast cancer
18-70 Years, female;
life expectancy is not less than 3 months
Histologically confirmed HER2 positive ( human epidermal growth factor receptor 2 [ HER2 ] positive, estrogen receptor [ ER ] and progesterone receptor [ PR ] negative or positive );
Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
Inflammatory breast cancer
patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
Parallel
lobaplatin
Drug30mg / m2 i.v. q3w
carboplatin
DrugAUC 5-6 i.v. q3w
Docetaxel or albumin paclitaxel
DrugDocetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w )
Trastuzumab
Drug6 cycles of treatment, according to the instructions recommended dosage.
pertuzumab
Drug6 cycles of treatment, according to the instructions recommended dosage.
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.
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.
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.
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.
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.
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.
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Shandong Cancer Hospital and Institute
Lead sponsor
Cancer Hospital Chinese Academy of Medical Science
Collaborator
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