drugset
drugset / Trial / NCT01917578

Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction

NCT01917578 ↗

Phase 3 Unknown 4 enrolled Shandong Cancer Hospital and Institute
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC has been associated with significantly higher ipsilateral breast tumor recurrences.The accuracy of breast tumor excision in BCS can dramatically reduce IBTR.The main reseason of IBTR might be the uncertain shrinkage modes of the breast cancer after NAC.This clinical trial is firstly carried out to make clear the shrinkage modes of the primary tumor after 3 cycles and whole cycles of NAC,respectively,with whole-mount serial section(WMSS) and three-dimensional(3D) pathological reconstruction of the residual tumor.The second objective is to investigate the predictive value of 3D MRI reconstruction for the shrinkage modes of the primary tumor after NAC.

Timeline

Start
2008-08
Primary completion
2014-03
Completion
2014-07

Publications

  • Results Y-S Wang, Z-P Zhang, G Liu, D-B Mu, and X-Y Sun.Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction. Cancer Res 2012;72(24 Suppl):Abstract nr P1-14-17.

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Cyclophosphamide Other / unclassified 75 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 100 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 30 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Subject Epirubicin Small molecule 60 mg/m2 Intravenous
Subject Epirubicin Small molecule 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Subject fluorouracil Small molecule 500 mg/m2 Intravenous

Indications

breast cancer