drugset / Trial / NCT02879513

Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

NCT02879513

Phase 3 Unknown 290 enrolled RenJi Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.

Timeline

Start
2014-01
Primary completion
2020-06
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2
Comparator Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Comparator Epirubicin Small molecule 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Comparator fluorouracil Small molecule 500 mg/m2 Intravenous