NCT03006614

PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer

Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Shi Yanxia · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer Model
• Effects of Chemotherapy
• Breast Cancer

Interventions

Type	Name	Description
DRUG	NVB
DRUG	EPI
DRUG	DDP
DRUG	CAP
DRUG	GEM
DRUG	H
DRUG	CTX
DRUG	T

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-03-01
• Completion: 2023-03-01
• First posted: 2016-12-30
• Last updated: 2017-01-16

Locations

1 site across 1 country: China