NCT01917578

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Ultrasound	1. Evaluation of the tumor size by sonography is performed before neoadjuvant chemotherapy and prior to surgery. 2. Measurement of tumor size refers to WHO standards.
PROCEDURE	CNB	Typically, the pretreatment tumor specimen will be a core needle biopsy. Because 15% to 28% of patients will have no residual tumor after NAT, it is important to have an adequate pretreatment sample in which an unequivocal diagnosis of invasive carcinoma is established and evaluation of hormone receptors and HER2/ neu status is completed before treatment.
PROCEDURE	BCS, Modified Radical Mastectomy	All patients after neoadjuvant chemotherapy are performed BCS and modified radical mastectomy.
DEVICE	Pathologic Large Tissue Selected Table	1. Pathologic large tissue selected table has obtained Chinese patent.Its license ID is CN101261200. 2. Each piece of breast tissues by cutting with the table has 3mm thickness.
DEVICE	Leica TP1020	Procedure: 1. Alcohol 70 % 1h 2. Alcohol 80 % 1h 3. Alcohol 85 % 1h 4. Alcohol 90 % 1h 5. Alcohol 95 % 1h 6. Alcohol Ⅰ 100 % 1h 7. Alcohol Ⅱ 100 % 1h 8. Xylene Ⅰ 2h 9. Xylene Ⅱ 2h 10. Xylene Ⅲ 2h 11. Paraffin 6h 12. Paraffin 6h
DEVICE	Pathologic Large Tissue Embedded Table	1. The table is made of brass .It is applying for a chinese patent. 2. The table can simultaneously embed 8 piece of breast tissues.
DEVICE	Leica SM2000 R	Each of paraffin section has 4 um thickness.
PROCEDURE	HE Stain	Procedure: 1. Xylene Ⅰ 60℃ 15-20 minutes 2. Xylene Ⅱ 60℃ 15-20 minutes 3. Alcohol 100% Ⅰ 3-5 minutes 4. Alcohol 100% Ⅱ 3-5 minutes 5. Alcohol 95% Ⅱ 3-5 minutes 6. Alcohol 90% Ⅱ 3-5 minutes 7. Wash in running tap water for 3 minutes 8. Hematoxylin 5-10 minutes 9. Wash in running tap water for 3 minutes 10. Differentiate in 1% acid alcohol for 30 seconds 11. Wash in running tap water for 1 minute 12. Bluing in 0.2% ammonia water for 30-60 seconds 13. Wash in running tap water for 3 minutes 14. Counterstain in eosin Y solution for 30-60 seconds 15. Wash in running tap water for 1 minute 16. Alcohol 90% Ⅱ 2-3 minutes 17. Alcohol 95% Ⅱ 2-3 minutes 18. Alcohol 100% Ⅱ 3-5 minutes 19. Alcohol 100% Ⅱ 3-5 minutes 20. Xylene Ⅲ 5-10 minutes 21. Xylene Ⅳ 5-10 minutes 22. Mounting with neutral resin
DEVICE	CX22	The residual tumor areas are microscopically outlined on each slice by pathologist.
DEVICE	Epson V600	1. Each slice that has been microscopically outlined is scanned by Epson V600. 2. Every image by scanning should be saved as JPG.
DEVICE	MRI	1. Evaluation of the tumor size by MRI was performed before neoadjuvant chemotherapy and prior to surgery. 2. Measurement of tumor size refers to WHO standards. 3. The images of patients which were scanned by MRI should be burned onto disc for 3d reconstruction.
PROCEDURE	Three-Dimensional Reconstruction	A.Pathological images three-dimensional reconstruction: 1. Pathological images registration is based on skin and shear mark by Photoshop 13.0 software. 2. Residual tumor boundary on Pathological images after registration are outlined and taken three-dimensional reconstruction by 3D-doctor 4.0 software. 3. Observe the shrinkage modes in three-dimensional space. 4. According to WHO standard,the boundaries of all residual tumor images are displayed in one plane and the longest diameter and its longest perpendicular diameter of boundaries are measured in one-dimensional space. 5. According to RECIST standard,the longest diameter of boundaries of residual tumor images in three-dimensional space. B.MRI images three-dimensional reconstruction:the procedure is similar to Pathological images three-dimensional reconstruction
DEVICE	Mammography	1. Evaluation of the tumor size by mammography is performed before neoadjuvant chemotherapy and prior to surgery. 2. Measurement of tumor size and calcification extent refers to WHO standards. 3. Calcification extent is not only measured in mammography image but also under microscope.
DRUG	TAC,TC,TA,CAF,CEF	1. TAC:Docetaxel 75 mg/㎡ iv day 1 + Doxorubicin 50 mg/㎡ in day 1 + Cyclophosphamide 500 mg/㎡ iv day 1(Cycled every 21 days for 3 cycles) 2. TC:Docetaxel 75 mg/㎡ iv day 1 + Cyclophosphamide 600 mg/㎡in day 1(Cycled every 21 days for 2 cycles) 3. TA:Docetaxel 75 mg/㎡ iv day 1 + Doxorubicin 50 mg/㎡ in day 1(Cycled every 21 days for 2 cycles) 4. CAF:Cyclophosphamide 100 mg/㎡ po days 1-14 + Doxorubicin 30 mg/㎡ iv days 1,8 +5-fluorouracil 500 mg/㎡ iv days 1,8(cycled every 28 days for 3 cycles) 5. CEF:Cyclophosphamide 75 mg/㎡ po day 1-14 + Epirubicin 60 mg/㎡ iv days 1,8 + 5-fluorouracil 500mg/㎡ iv days 1,8(cycled every 28 days for 3 cycles)
DRUG	AC-P,TEC,AC,TC,TCH,CEF,TAC,CAF	1. AC-P:Doxorubicin 60 mg/㎡ iv day 1 +Cyclophosphamide 600 mg/㎡ iv day 1(Cycled every 14 days for 4 cycles)→ Paclitaxel 175mg/㎡ by 3h iv infusion day 1(Cycled every 14 days for 4 cycles) or Paclitaxel 80mg/㎡ by 1h iv infusion weekly for 12 wks. 2. TEC:Docetaxel 75 mg/㎡ iv day 1 + Epirubicin 75 mg/㎡ in day 1 + Cyclophosphamide 500 mg/㎡ iv day 1(Cycled every 21 days for 6 cycles) 3. AC:Doxorubicin 60 mg/㎡ in day 1 + Cyclophosphamide 600 mg/㎡ iv day 1(Cycled every 21 days for 4 cycles) 4. TC:Docetaxel 75 mg/㎡ iv day 1 + Cyclophosphamide 600 mg/㎡in day 1(Cycled every 21 days for 4 cycles) 5. TCH:Docetaxel 75 mg/㎡ iv day 1 + Carboplatin AUC 6 iv day1(Cycled every 21 days for 6 cycles) + Trastuzumab 4 mg/kg iv wk 1 → Trastuzumab 2 mg/kg iv for 17 wks → Trastuzumab 6 mg/kg iv every 3 wks to complete 1 year. 6. CEF:Cyclophosphamide 75 mg/㎡ po day 1-14 + Epirubicin 60 mg/㎡ iv days 1,8 + 5-fluorouracil 500mg/㎡ iv days 1,8(cycled every 28 days for 6 cycles)

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-03-01
• Completion: 2014-07-01
• First posted: 2013-08-06
• Last updated: 2013-08-06

Locations

1 site across 1 country: China