Study: NCT01917578

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ultrasound
Description: 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.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ultrasound
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: CNB
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: CNB
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: BCS, Modified Radical Mastectomy
Description: All patients after neoadjuvant chemotherapy are performed BCS and modified radical mastectomy.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: BCS, Modified Radical Mastectomy
Description: All patients after neoadjuvant chemotherapy are performed BCS and modified radical mastectomy.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Pathologic Large Tissue Selected Table
Description: 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.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Pathologic Large Tissue Selected Table
Description: 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.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Leica TP1020
Description: 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

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Leica TP1020
Description: 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

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Pathologic Large Tissue Embedded Table
Description: 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.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Pathologic Large Tissue Embedded Table
Description: 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.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Leica SM2000 R
Description: Each of paraffin section has 4 um thickness.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Leica SM2000 R
Description: Each of paraffin section has 4 um thickness.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: HE Stain
Description: 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

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: HE Stain
Description: 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

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CX22
Description: The residual tumor areas are microscopically outlined on each slice by pathologist.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CX22
Description: The residual tumor areas are microscopically outlined on each slice by pathologist.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Epson V600
Description: 1. Each slice that has been microscopically outlined is scanned by Epson V600.~2. Every image by scanning should be saved as JPG.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Epson V600
Description: 1. Each slice that has been microscopically outlined is scanned by Epson V600.~2. Every image by scanning should be saved as JPG.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MRI
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Three-Dimensional Reconstruction
Description: 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

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Three-Dimensional Reconstruction
Description: 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

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Mammography
Description: 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.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Mammography
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAC,TC,TA,CAF,CEF
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AC-P,TEC,AC,TC,TCH,CEF,TAC,CAF
Description: 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)