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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Half Cycles Group | Experimental | Patients complete half of the whole cycles of neoadjuvant chemotherapy. |
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| Whole Cycles Group | Experimental | Patients complete whole cycles of neoadjuvant chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| The shrinkage modes of breast tumor after NAC. | 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). | 6 year |
| Measure | Description | Time Frame |
|---|---|---|
| The WMSS and 3D pathological reconstruction of the residual tumors after NAC. | The whole-mount serial section(WMSS) and three-dimensional(3D) pathological reconstruction of the residual tumors after NAC. | 6 year |
| Measure | Description | Time Frame |
|---|---|---|
| The predictive value of 3D MRI reconstruction for the shrinkage modes of primary tumor after NAC. | The predictive value of 3D MRI reconstruction for the shrinkage modes of the primary tumor after whole cycles of NAC. | 4 year |
Inclusion Criteria:
Female patients,locally advanced breast cancer,age ≥18 years.
Histologically confirmed invasive adenocarcinoma of the breast.
Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter by physical exam or imaging studies (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)
Patients without clearly defined palpable breast mass or axillary lymph nodes but radiographically measurable tumor masses are acceptable. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. This will need to be re-evaluated after 3 cycles and prior to surgery.
ECOG 0 or 2
No distant metastasis, as documented by complete staging workup ≤6 weeks prior to initiation of study treatment.
No previous treatment for breast cancer.
Adequate hematologic function with:
Absolute neutrophil count (ANC) >1500/μL. Platelets ≥100,000/μL. Hemoglobin ≥10 g/dL.
Adequate hepatic function with:
Serum bilirubin ≤ the institutional upper limit of normal (ULN). Aspartate aminotransferase (AST) ≤2.5 x institutional ULN. Alanine aminotransferase (ALT) ≤2.5 x institutional ULN.
Adequate renal function with serum creatinine ≤1.5 x ULN.
Planned primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant chemotherapy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong-sheng Wang, MD | Contact | +8613505409989 | wangysh2008@aliyun.com | |
| Tao Yang, MD | Contact | +8618264190568 | yangtao133252@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong-sheng Wang, MD | Shandong Cancer Hospital and Institute | Study Chair |
| Tao Yang, MD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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| CNB | Procedure | 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. |
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| BCS, Modified Radical Mastectomy | Procedure | All patients after neoadjuvant chemotherapy are performed BCS and modified radical mastectomy. |
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| Pathologic Large Tissue Selected Table | Device |
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| Leica TP1020 | Device | Procedure:
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| Pathologic Large Tissue Embedded Table | Device |
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| Leica SM2000 R | Device | Each of paraffin section has 4 um thickness. |
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| HE Stain | Procedure | Procedure:
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| CX22 | Device | The residual tumor areas are microscopically outlined on each slice by pathologist. |
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| Epson V600 | Device |
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| MRI | Device |
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| Three-Dimensional Reconstruction | Procedure | A.Pathological images three-dimensional reconstruction:
B.MRI images three-dimensional reconstruction:the procedure is similar to Pathological images three-dimensional reconstruction |
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| Mammography | Device |
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| TAC,TC,TA,CAF,CEF | Drug |
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| AC-P,TEC,AC,TC,TCH,CEF,TAC,CAF | Drug |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D062005 | Biopsy, Large-Core Needle |
| D015412 | Mastectomy, Segmental |
| D015411 | Mastectomy, Modified Radical |
| D008327 | Mammography |
| C038334 | AC protocol |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| C098534 | EC regimen |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |
| D008408 | Mastectomy |
| D015409 | Mastectomy, Radical |
| D011859 | Radiography |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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