ID

44357

Description

Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction; ODM derived from: https://clinicaltrials.gov/show/NCT01917578

Link

https://clinicaltrials.gov/show/NCT01917578

Keywords

Versions (2)
  1. 11/6/17 11/6/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01917578

English

Eligibility Breast Cancer NCT01917578

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patients,locally advanced breast cancer,age ≥18 years.
Description

Gender | Locally advanced breast cancer | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0001779
2. histologically confirmed invasive adenocarcinoma of the breast.
Description

Breast adenocarcinoma Invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
3. 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.)
Description

Palpable disease Primary Breast Physical Examination | Palpable disease Primary Axilla Physical Examination | Axillary lymphadenopathy Absent | Primary tumor Diameter Physical Examination TNM Breast tumor staging | Primary tumor Diameter Imaging studies TNM Breast tumor staging | Axillary lymphadenopathy Suspicious | Primary tumor Size TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0522499
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0031809
UMLS CUI [2,1]
C0522499
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0004454
UMLS CUI [2,4]
C0031809
UMLS CUI [3,1]
C0578735
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0677930
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C0031809
UMLS CUI [4,4]
C0474926
UMLS CUI [5,1]
C0677930
UMLS CUI [5,2]
C1301886
UMLS CUI [5,3]
C1881134
UMLS CUI [5,4]
C0474926
UMLS CUI [6,1]
C0578735
UMLS CUI [6,2]
C0750493
UMLS CUI [7,1]
C0677930
UMLS CUI [7,2]
C0456389
UMLS CUI [7,3]
C0474926
4. 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.
Description

Palpable breast mass Absent | Axillary lymph nodes Palpable Absent | Tumor Mass Measurable Radiography | Mammography | MRI | Ultrasonography, Mammary

Data type

boolean

Alias
UMLS CUI [1,1]
C1403543
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C0522499
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3273930
UMLS CUI [3,2]
C1513040
UMLS CUI [3,3]
C0034571
UMLS CUI [4]
C0024671
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0080264
5. ecog 0 or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. no distant metastasis, as documented by complete staging workup ≤6 weeks prior to initiation of study treatment.
Description

Distant metastasis Absent TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0474926
7. no previous treatment for breast cancer.
Description

Prior Therapy Absent Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
8. adequate hematologic function with:
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
absolute neutrophil count (anc) >1500/μl. platelets ≥100,000/μl. hemoglobin ≥10 g/dl.
Description

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
9. adequate hepatic function with:
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
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.
Description

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
10. adequate renal function with serum creatinine ≤1.5 x uln.
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
11. planned primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant chemotherapy
Description

Systemic Chemotherapy Neoadjuvant Primary | Excision Primary tumor Residual | Mastectomy | Lumpectomy | Breast-Conserving Surgery | Chemotherapy Neoadjuvant Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0677930
UMLS CUI [2,3]
C1609982
UMLS CUI [3]
C0024881
UMLS CUI [4]
C0024885
UMLS CUI [5]
C0917927
UMLS CUI [6,1]
C0392920
UMLS CUI [6,2]
C0600558
UMLS CUI [6,3]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inflammatory breast cancer
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
2. pregnancy or breast-feeding.a negative serum pregnancy test within 7 days prior to first study treatment (day 1, cycle 1) for all women of childbearing potential is required. patients of childbearing potential must agree to use a birth control method that is approved by their study physician while receiving study treatment and for 3 weeks after their last dose of study treatment. patients must agree to not breast-feed while receiving study treatment.
Description

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
3. concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (serm). patients must have discontinued use of such agents prior to beginning study treatment.
Description

Hormone replacement therapy ovarian | Hormone preparation To be stopped | Raloxifene To be stopped | Tamoxifen To be stopped | Selective Estrogen Receptor Modulators To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C0205065
UMLS CUI [2,1]
C0019932
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0244404
UMLS CUI [3,2]
C1272691
UMLS CUI [4,1]
C0039286
UMLS CUI [4,2]
C1272691
UMLS CUI [5,1]
C0732611
UMLS CUI [5,2]
C1272691
4. uncontrolled intercurrent illness including (but not limited to) ongoing or active infection.
Description

Comorbidity Uncontrolled | Communicable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
5. concurrent treatment with any anti-cancer therapy other than those agents used in this study.
Description

Cancer treatment | Exception Investigational New Drugs Clinical Trial Current

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0521116
6. mental condition or psychiatric disorder that would prevent patient comprehension of the nature, scope, and possible consequences of the study or that would limit compliance with study requirements.
Description

Mental condition Preventing Comprehension Study Protocol | Mental disorders Preventing Comprehension Study Protocol | Mental condition Limiting Protocol Compliance | Mental disorders Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C2348563
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
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Similar models

Eligibility Breast Cancer NCT01917578

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Locally advanced breast cancer | Age
Item
1. female patients,locally advanced breast cancer,age ≥18 years.
boolean
C0079399 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Breast adenocarcinoma Invasive
Item
2. histologically confirmed invasive adenocarcinoma of the breast.
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Palpable disease Primary Breast Physical Examination | Palpable disease Primary Axilla Physical Examination | Axillary lymphadenopathy Absent | Primary tumor Diameter Physical Examination TNM Breast tumor staging | Primary tumor Diameter Imaging studies TNM Breast tumor staging | Axillary lymphadenopathy Suspicious | Primary tumor Size TNM Breast tumor staging
Item
3. 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.)
boolean
C0522499 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
C0522499 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0004454 (UMLS CUI [2,3])
C0031809 (UMLS CUI [2,4])
C0578735 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677930 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0031809 (UMLS CUI [4,3])
C0474926 (UMLS CUI [4,4])
C0677930 (UMLS CUI [5,1])
C1301886 (UMLS CUI [5,2])
C1881134 (UMLS CUI [5,3])
C0474926 (UMLS CUI [5,4])
C0578735 (UMLS CUI [6,1])
C0750493 (UMLS CUI [6,2])
C0677930 (UMLS CUI [7,1])
C0456389 (UMLS CUI [7,2])
C0474926 (UMLS CUI [7,3])
Palpable breast mass Absent | Axillary lymph nodes Palpable Absent | Tumor Mass Measurable Radiography | Mammography | MRI | Ultrasonography, Mammary
Item
4. 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.
boolean
C1403543 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0729594 (UMLS CUI [2,1])
C0522499 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3273930 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
C0024671 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0080264 (UMLS CUI [6])
ECOG performance status
Item
5. ecog 0 or 2
boolean
C1520224 (UMLS CUI [1])
Distant metastasis Absent TNM Breast tumor staging
Item
6. no distant metastasis, as documented by complete staging workup ≤6 weeks prior to initiation of study treatment.
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Prior Therapy Absent Breast Carcinoma
Item
7. no previous treatment for breast cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Hematologic function
Item
8. adequate hematologic function with:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
absolute neutrophil count (anc) >1500/μl. platelets ≥100,000/μl. hemoglobin ≥10 g/dl.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Liver function
Item
9. adequate hepatic function with:
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
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.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Renal function | Creatinine measurement, serum
Item
10. adequate renal function with serum creatinine ≤1.5 x uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Systemic Chemotherapy Neoadjuvant Primary | Excision Primary tumor Residual | Mastectomy | Lumpectomy | Breast-Conserving Surgery | Chemotherapy Neoadjuvant Completed
Item
11. planned primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant chemotherapy
boolean
C1883256 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0728940 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C1609982 (UMLS CUI [2,3])
C0024881 (UMLS CUI [3])
C0024885 (UMLS CUI [4])
C0917927 (UMLS CUI [5])
C0392920 (UMLS CUI [6,1])
C0600558 (UMLS CUI [6,2])
C0205197 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Inflammatory Breast Carcinoma
Item
1. inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
2. pregnancy or breast-feeding.a negative serum pregnancy test within 7 days prior to first study treatment (day 1, cycle 1) for all women of childbearing potential is required. patients of childbearing potential must agree to use a birth control method that is approved by their study physician while receiving study treatment and for 3 weeks after their last dose of study treatment. patients must agree to not breast-feed while receiving study treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Hormone replacement therapy ovarian | Hormone preparation To be stopped | Raloxifene To be stopped | Tamoxifen To be stopped | Selective Estrogen Receptor Modulators To be stopped
Item
3. concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (serm). patients must have discontinued use of such agents prior to beginning study treatment.
boolean
C0282402 (UMLS CUI [1,1])
C0205065 (UMLS CUI [1,2])
C0019932 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0244404 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
C0732611 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Comorbidity Uncontrolled | Communicable Disease
Item
4. uncontrolled intercurrent illness including (but not limited to) ongoing or active infection.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
Cancer treatment | Exception Investigational New Drugs Clinical Trial Current
Item
5. concurrent treatment with any anti-cancer therapy other than those agents used in this study.
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0521116 (UMLS CUI [2,4])
Mental condition Preventing Comprehension Study Protocol | Mental disorders Preventing Comprehension Study Protocol | Mental condition Limiting Protocol Compliance | Mental disorders Limiting Protocol Compliance
Item
6. mental condition or psychiatric disorder that would prevent patient comprehension of the nature, scope, and possible consequences of the study or that would limit compliance with study requirements.
boolean
C3840291 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C3840291 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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