Phase III Trail of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction (BCSMANC)

NCT01917578 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Shandong Cancer Hospital and Institute
Phase	Phase 3
Status	UNKNOWN
Enrolment	4
Start date	2008-08
Completion	2014-07

Conditions

• Breast Cancer

Interventions

• Ultrasound
• CNB
• BCS, Modified Radical Mastectomy
• Pathologic Large Tissue Selected Table
• Leica TP1020
• Pathologic Large Tissue Embedded Table
• Leica SM2000 R
• HE Stain
• CX22
• Epson V600

Primary outcomes

• The shrinkage modes of breast tumor after NAC. — 6 year
  The tumor shrinkage modes of the primary tumor in patients with locally advanced breast cancer after 3 cycles and whole cycles of neoadjuvant chemotherapy(NAC).

Countries

China