PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer
- Registration Number
- NCT03006614
- Lead Sponsor
- Shi Yanxia
- Brief Summary
This study aims to explore new PERS prediction model can improve the pathological complete response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.
- Detailed Description
This is a multi-center, prospective, randomized phase III clinical trial. Planning 320 cases.
This study will be divided into two stages. Phase one, 120 cases of local advanced breast cancer (LABC)who need neoadjuvant chemotherapy. Gene prediction model test(PERS) is performed before treatment(ddEC-T+/-H), verify the prediction efficacy of PERS.
Phase two, 200 cases of LABC primary resistant of antharcycline and taxans. Patients were randomized to Arm ddEC-T+/-H and Arm PERS (regimens according to PERS,eg NVB+DDP,capacitabine,gemcitabine and so on) pCR rate and DFS is observed.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 320
Not provided
- ECOG(Eastern Cooperative Oncology Group) scoring ≥2 ;
- At the same time to accept any other anti-tumor treatment.
- In the past 12 months have congestive heart failure, drug treatment can't control history of arrhythmia, myocardial infarction, etc;
- The serious, which has not been controlled intercurrent infection, organ dysfunction, or serious metabolic disorder of patients;
- Active infection (decided by the researchers.
- According to the researcher's judgment, there is serious to endanger the safety of patients, or patients completed the research associated with disease.
- Pregnancy or breast-feeding women.
- Always have a clear history of neurological or psychiatric disorders, including epilepsy, or dementia.
- A history of other tumors or combined with other tumor patients.
- Before study enrollment for any reason within 30 days of use had not been approved by the local drug ；
- Unwilling or unable to continue to comply with the experimental program, or can not cope with patients follow-up;
- Researchers think that is unfavorable to the participants.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PERS:NVB,DDP,GEM,CAP,H etc. GEM vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab EPI+CTX-T+/-H H Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w PERS:NVB,DDP,GEM,CAP,H etc. H vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab PERS:NVB,DDP,GEM,CAP,H etc. CAP vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab EPI+CTX-T+/-H CTX Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w EPI+CTX-T+/-H T Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w PERS:NVB,DDP,GEM,CAP,H etc. NVB vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab EPI+CTX-T+/-H EPI Epirubicin 90mg/m2 d1+ CTX 600mg/m2 d1 q2w, Docetaxel 75mg/m2 +/-herceptin d1,q3w PERS:NVB,DDP,GEM,CAP,H etc. DDP vinorelbine 25mg/m2 d1,d8 iv,q3w cisplatin 70mg/m2 d1，q3w gemcitabine 1000mg/m2 d1,d8,q3w capecitabine 1000mg/m2,bid,d1-14,q3w Trastuzumab
- Primary Outcome Measures
Name Time Method Surgical specimens of breast primary tumors and axillary lymph nodes as measured by Pathological examination. up to 96 months pCR(pathologic complete response)
- Secondary Outcome Measures
Name Time Method Time as a measure from randomization to disease recurrence or patients died due to disease progression. up to 96 months DFS(Disease-free survival)
Trial Locations
- Locations (1)
Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China