NCT02506361

Evaluation of the Relationship of TOP2α Expression and Effect of Non Dose-dense Chemotherapy for Breast Cancer

Evaluation of the Relationship of TOP2α Expression and Effect of Anthracyclines Followed Taxanes or Contains no Taxanes Non Dose-dense Chemotherapy for Breast Cancer: a Prospective, Non-interventional, Multicentre Trail

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective、multicenter、non-comparative interventional case series. 800 breast cancer patients who have already received chemotherapy prior to this study will be enrolled in the group, including 400 patients received the anthracyclines followed taxanes chemotherapy, and the other 400 patients who have received regiments containing no taxanes. Three tumor tissue slices of all the enrolled patients will be collected for TOP2α assay. Meanwhile, 10 years followed-up survey will be conducted. The relationship of TOP2α expression and 5- year or 10-year disease free survival(DFS) and overall survival（OS）will be identified in this study.

Detailed description

800 breast cancer patients who have received chemotherapy prior to this study will be enrolled in the group, including 400 patients received the anthracyclines followed taxanes chemotherapy(Epirubicin 90 mg/m2 d1, Cyclophosphamide 600mg/m2 d1，21days/cycle, 4 cycles, followed by Docetaxel 75mg/m2,d1, 21days/cycle, 4 cycles;or paclitaxel：Epirubicin 90 mg/m2 d1 cyclophosphamide 600mg/m2 d1, 21day/cycle, 4 cycles, followed by paclitaxel 80mg/m2, weekly, 12 wks), and the other 400 patients who have received regiments containing no taxanes (FEC：5-FU 600mg/m2 d1,Epirubicin 90mg/m2 d1, Cyclophosphamide 500mg/m2 d1, 21day/cycle, 6 cycles; or EC: Epirubicin 90mg/m2 d1, Cyclophosphamide 500mg/m2 d1,21 day/cycle, 6 cycles).The patients will be enrolled in the groups within one month after chemotherapy.Three tumor tissue slices of all the enrolled patients will be collected for TOP2α assay. Meanwhile, 10 years followed-up survey will be conducted. The relationship of TOP2α expression and 5-year or 10-year disease free survival(DFS) and overall survival（OS）will be identified in this study.

Conditions

• Breast Cancer

Timeline

• Start date: 2015-05-01
• Primary completion: 2025-05-01
• Completion: 2025-10-01
• First posted: 2015-07-23
• Last updated: 2015-07-23

Locations

1 site across 1 country: China