Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
- Conditions
- Tubular Breast CancerInflammatory Breast CancerInvasive Ductal Breast CancerMucinous Breast Cancer
- Interventions
- Registration Number
- NCT02221999
- Lead Sponsor
- RenJi Hospital
- Brief Summary
The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate.
Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.
- Detailed Description
In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy.
Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 250
- Women aged ≥18years and ≤70 years;
- At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0;
- ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as >1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals >2.0 or HER2 gene copy >6.0.
- No prior systemic or loco-regional treatment of breast cancer;
- Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
- No obvious main organs dysfunction.
- Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
- Patient is pregnant or breast feeding;
- Inflammatory breast cancer and metastatic breast cancer;
- Any evidence of sense or motor nerve disorders;
- Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
- Any concurrent malignancy other than breast cancer;
- Know severe hypersensitivity to any drugs in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GnRHa Gonadotropin-releasing hormone agonist Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Gonadotropin-releasing hormone agonist （GnRHa）11.25 mg every 3 months or 3.6mg every month subcutaneously Chemotherapy only Paclitaxel Paclitaxel injection 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle；Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle； for 4 cycles letrozole Paclitaxel Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Letrozole 2.5mg/day Chemotherapy only Cisplatin Paclitaxel injection 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle；Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle； for 4 cycles GnRHa Paclitaxel Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Gonadotropin-releasing hormone agonist （GnRHa）11.25 mg every 3 months or 3.6mg every month subcutaneously GnRHa Cisplatin Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Gonadotropin-releasing hormone agonist （GnRHa）11.25 mg every 3 months or 3.6mg every month subcutaneously letrozole Cisplatin Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Letrozole 2.5mg/day letrozole Letrozole Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Letrozole 2.5mg/day
- Primary Outcome Measures
Name Time Method pathological complete remission rate after 4 months preoperative treatment Pathological complete remission is defined as no invasive cancer in breast and axillary nodes.
- Secondary Outcome Measures
Name Time Method local recurrence free survival (LRFS) 5 years LRFS is defined as the time period between registration and first event
overall survival (OS) 5 years OS is defined as the time period between registration and first event
rate of tumor remission （RTR） after 2 cycles and 4 cycles during neoadjuvant therapy RTR is defined as the proportion of tumor remission per unit time
disease free survival (DFS) 5 years DFS is defined as the time in months from randomization until first occurrence of locoregional recurrence, distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause.
regional recurrence free survival (RRFS) 5 years RRFS is defined as the time period between registration and first event
serum markers Pre-treatment and/or surgical Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery
Number of Participants With Drug Related Treatment Adverse Events 4 months during neoadjuvant therapy Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.
distant-disease- free survival (DDFS) 5 years DDFS is defined as the time period between registration and first event
Clinical and imaging response 4 months during treatment To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment
molecular markers Pre-treatment and/or surgical Pre-treatment and surgical expression of molecular markers （LHRHa receptor, EGFR，PD-L1)
Trial Locations
- Locations (12)
Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital
🇨🇳Shenzhen, Guangdong, China
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
The second people's hospital of Kunshan city
🇨🇳Kunshan, Jiangsu, China
HanDan Central Hospital
🇨🇳Handan, Hebei, China
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage
🇨🇳Hohhot, Inner Mongolia, China
Department of Medical Oncology, General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Shanghai Jiaotong University School of Medicine, Renji Hospital
🇨🇳Shanghai, Shanghai, China
Yueyang hospital of integrated traditional Chinese and Western medine
🇨🇳Shanghai, Shanghai, China
Armed Police Corps Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Zhoushan hospital
🇨🇳Zhoushan, Zhejiang, China