ID

35013

Description

Carboplatin in EARLY Triple Negative Breast Cancer Trial (PEARLY Trial); ODM derived from: https://clinicaltrials.gov/show/NCT02441933

Link

https://clinicaltrials.gov/show/NCT02441933

Keywords

Versions (1)
  1. 2/9/19 2/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02441933

English

Eligibility Breast Cancer NCT02441933

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patients who are >18 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. ecog 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
3. the tumor must be invasive carcinoma of the breast on histologic examination
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
4. the tumor must have been determined to be her2-negative, as follows:
Description

Neoplasm HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2348908
ihc 0 or 1+; or
Description

Immunohistochemistry Result

Data type

boolean

Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C1274040
ihc 2+ and ish non-amplified, with a ratio of <2.0, and if reported, an average her2 gene copy number of <6 signals/cell; or
Description

Immunohistochemistry Result | In Situ Hybridization | HER2 Gene copy number Average Signal cell

Data type

boolean

Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C1274040
UMLS CUI [2]
C0162788
UMLS CUI [3,1]
C0242957
UMLS CUI [3,2]
C0178655
UMLS CUI [3,3]
C1510992
UMLS CUI [3,4]
C0037083
ish non-amplified without ihc
Description

In Situ Hybridization | Immunohistochemistry Absent

Data type

boolean

Alias
UMLS CUI [1]
C0162788
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C0332197
5. the tumor must have been determined to be er- and pr-negative, as assessed by the current asco/cap guidelines.
Description

Neoplasm Estrogen receptor negative | Neoplasm Progesterone receptor negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279756
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0279766
6. all of the following staging criteria (ajcc 7th edition) must be met:
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
lymph node-positive disease: cytologically positive in the neoadjuvant group*
Description

Disease Lymph node positive Cytology

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0746319
UMLS CUI [1,3]
C1305671
and pathologically positive in the adjuvant group
Description

Disease Lymph node positive Pathology

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0746319
UMLS CUI [1,3]
C0919386
if the lymph node is cytologically or pathologically negative, the tumor size must be >2.0 cm (* in the neoadjuvant group, if there is evidence of suspicious axillary lymph nodes at the baseline imaging study or physical examination, then fna or core biopsy is required to confirm the nodal status)
Description

Negative Lymph Node | Tumor size | Axillary lymph nodes Suspicious Requirement Fine needle aspiration biopsy | Axillary lymph nodes Suspicious Requirement Core needle biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0678034
UMLS CUI [2]
C0475440
UMLS CUI [3,1]
C0729594
UMLS CUI [3,2]
C0750493
UMLS CUI [3,3]
C1514873
UMLS CUI [3,4]
C1510483
UMLS CUI [4,1]
C0729594
UMLS CUI [4,2]
C0750493
UMLS CUI [4,3]
C1514873
UMLS CUI [4,4]
C1318309
7. the patient must have undergone either a mastectomy or lumpectomy in the adjuvant group
Description

Mastectomy | Segmental Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C0024881
UMLS CUI [2]
C0024885
8. the patient must have completed one of the nodal surgery procedures listed below in the adjuvant group:
Description

Operative Surgical Procedure Lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0024204
sentinel lymph node biopsy (slnb) alone:
Description

Sentinel Lymph Node Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0796693
v if pathologic nodal staging based on slnb is pn0 v if pathologic nodal staging based on slnb is 1 or 2 positive nodes, the primary tumor must be t1 or t2 by pathologic evaluation and lumpectomy and the nodal involvement must be limited to 1 or 2 positive nodes
Description

Sentinel Lymph Node Biopsy Pathologic TNM stage | Primary tumor Pathologic TNM stage | Segmental Mastectomy | Lymph Node Involvement Node positive Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0796693
UMLS CUI [1,2]
C1319019
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C1319019
UMLS CUI [3]
C0024885
UMLS CUI [4,1]
C0806692
UMLS CUI [4,2]
C0746319
UMLS CUI [4,3]
C1265611
slnb followed by removal of additional non-sentinel lns if the sln is positive; or
Description

Sentinel Lymph Node Biopsy Followed by Lymph node excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0796693
UMLS CUI [1,2]
C0332283
UMLS CUI [1,3]
C0024203
axillary lymphadenectomy with or without slnb (in the neoadjuvant group, if baseline ln nab or core biopsy is positive, alnd should be performed) 9) lvef assessment by echocardiography or muga scan must be >50%, regardless of the cardiac imaging facility's lower limit of normal 10) the patient must have adequate hepatic, renal, and bone marrow function;
Description

Excision of axillary lymph nodes | Sentinel Lymph Node Biopsy | Sentinel Lymph Node Biopsy Absent | Fine needle aspiration of lymph node Positive | Core needle biopsy of lymph node Positive | Excision of axillary lymph nodes | Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA | Liver function | Renal function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0193867
UMLS CUI [2]
C0796693
UMLS CUI [3,1]
C0796693
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0398442
UMLS CUI [4,2]
C1514241
UMLS CUI [5,1]
C0193847
UMLS CUI [5,2]
C1514241
UMLS CUI [6]
C0193867
UMLS CUI [7,1]
C0428772
UMLS CUI [7,2]
C0013516
UMLS CUI [8,1]
C0428772
UMLS CUI [8,2]
C0521317
UMLS CUI [9]
C0232741
UMLS CUI [10]
C0232804
UMLS CUI [11,1]
C0005953
UMLS CUI [11,2]
C0031843
bone marrow function hb: ≥ 10.0 g/dl anc: ≥ 1,500/µl platelet count: ≥ 10 × 10⁴/µl
Description

Bone Marrow function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
renal function creatinine: ≤ 1.5 × unl or creatine clearance (ccr) >50 ml/min by the cockcroft formula
Description

Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
hepatic function total bilirubin: ≤ 1.5 × unl ast/alt: ≤ 2.5 × unl 10) ability and willingness to comply with the study visits, treatment, testing, and with the protocol, as per investigator's judgment
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any prior systemic treatment for primary invasive breast cancer
Description

Systemic therapy Primary invasive malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C4076461
2. ct4 or pt4 tumors including inflammatory breast cancer
Description

Neoplasm TNM Breast tumor staging | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0278601
3. occult breast cancer
Description

Occult Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C4527188
4. evidence of metastatic breast cancer
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
5. patients with second primary cancer; exceptions: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, dcis of the breast, thyroid cancer with a size of <2 cm (papillary, follicular, and medullary type), and other solid tumors curatively treated with no evidence of disease for >5 years prior to randomization.
Description

Second Primary Cancer | Exception Skin carcinoma Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception DCIS | Exception Thyroid carcinoma Size | Exception Papillary thyroid carcinoma | Exception Follicular thyroid carcinoma | Exception Medullary carcinoma of thyroid | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007124
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0549473
UMLS CUI [5,3]
C0456389
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0238463
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0206682
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0238462
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C1273390
UMLS CUI [9,3]
C0280100
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0012634
UMLS CUI [10,3]
C0332296
UMLS CUI [10,4]
C0449238
6. simultaneous bilateral breast cancer
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
7. patients considered a poor medical risk due to a serious, uncontrolled medical disorder or uncontrolled infection.
Description

Low Risk Disease Serious Uncontrolled | Low Risk Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C3538919
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0205318
UMLS CUI [2,1]
C3538919
UMLS CUI [2,2]
C0009450
UMLS CUI [2,3]
C0205318
8. pregnant or breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02441933

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. female patients who are >18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
2. ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Invasive carcinoma of breast
Item
3. the tumor must be invasive carcinoma of the breast on histologic examination
boolean
C0853879 (UMLS CUI [1])
Neoplasm HER2 Negative
Item
4. the tumor must have been determined to be her2-negative, as follows:
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
Immunohistochemistry Result
Item
ihc 0 or 1+; or
boolean
C0021044 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Immunohistochemistry Result | In Situ Hybridization | HER2 Gene copy number Average Signal cell
Item
ihc 2+ and ish non-amplified, with a ratio of <2.0, and if reported, an average her2 gene copy number of <6 signals/cell; or
boolean
C0021044 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0162788 (UMLS CUI [2])
C0242957 (UMLS CUI [3,1])
C0178655 (UMLS CUI [3,2])
C1510992 (UMLS CUI [3,3])
C0037083 (UMLS CUI [3,4])
In Situ Hybridization | Immunohistochemistry Absent
Item
ish non-amplified without ihc
boolean
C0162788 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Neoplasm Estrogen receptor negative | Neoplasm Progesterone receptor negative
Item
5. the tumor must have been determined to be er- and pr-negative, as assessed by the current asco/cap guidelines.
boolean
C0027651 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0279766 (UMLS CUI [2,2])
TNM Breast tumor staging
Item
6. all of the following staging criteria (ajcc 7th edition) must be met:
boolean
C0474926 (UMLS CUI [1])
Disease Lymph node positive Cytology
Item
lymph node-positive disease: cytologically positive in the neoadjuvant group*
boolean
C0012634 (UMLS CUI [1,1])
C0746319 (UMLS CUI [1,2])
C1305671 (UMLS CUI [1,3])
Disease Lymph node positive Pathology
Item
and pathologically positive in the adjuvant group
boolean
C0012634 (UMLS CUI [1,1])
C0746319 (UMLS CUI [1,2])
C0919386 (UMLS CUI [1,3])
Negative Lymph Node | Tumor size | Axillary lymph nodes Suspicious Requirement Fine needle aspiration biopsy | Axillary lymph nodes Suspicious Requirement Core needle biopsy
Item
if the lymph node is cytologically or pathologically negative, the tumor size must be >2.0 cm (* in the neoadjuvant group, if there is evidence of suspicious axillary lymph nodes at the baseline imaging study or physical examination, then fna or core biopsy is required to confirm the nodal status)
boolean
C0678034 (UMLS CUI [1])
C0475440 (UMLS CUI [2])
C0729594 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C1510483 (UMLS CUI [3,4])
C0729594 (UMLS CUI [4,1])
C0750493 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
C1318309 (UMLS CUI [4,4])
Mastectomy | Segmental Mastectomy
Item
7. the patient must have undergone either a mastectomy or lumpectomy in the adjuvant group
boolean
C0024881 (UMLS CUI [1])
C0024885 (UMLS CUI [2])
Operative Surgical Procedure Lymph nodes
Item
8. the patient must have completed one of the nodal surgery procedures listed below in the adjuvant group:
boolean
C0543467 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Sentinel Lymph Node Biopsy
Item
sentinel lymph node biopsy (slnb) alone:
boolean
C0796693 (UMLS CUI [1])
Sentinel Lymph Node Biopsy Pathologic TNM stage | Primary tumor Pathologic TNM stage | Segmental Mastectomy | Lymph Node Involvement Node positive Quantity
Item
v if pathologic nodal staging based on slnb is pn0 v if pathologic nodal staging based on slnb is 1 or 2 positive nodes, the primary tumor must be t1 or t2 by pathologic evaluation and lumpectomy and the nodal involvement must be limited to 1 or 2 positive nodes
boolean
C0796693 (UMLS CUI [1,1])
C1319019 (UMLS CUI [1,2])
C0677930 (UMLS CUI [2,1])
C1319019 (UMLS CUI [2,2])
C0024885 (UMLS CUI [3])
C0806692 (UMLS CUI [4,1])
C0746319 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Sentinel Lymph Node Biopsy Followed by Lymph node excision
Item
slnb followed by removal of additional non-sentinel lns if the sln is positive; or
boolean
C0796693 (UMLS CUI [1,1])
C0332283 (UMLS CUI [1,2])
C0024203 (UMLS CUI [1,3])
Excision of axillary lymph nodes | Sentinel Lymph Node Biopsy | Sentinel Lymph Node Biopsy Absent | Fine needle aspiration of lymph node Positive | Core needle biopsy of lymph node Positive | Excision of axillary lymph nodes | Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA | Liver function | Renal function | Bone Marrow function
Item
axillary lymphadenectomy with or without slnb (in the neoadjuvant group, if baseline ln nab or core biopsy is positive, alnd should be performed) 9) lvef assessment by echocardiography or muga scan must be >50%, regardless of the cardiac imaging facility's lower limit of normal 10) the patient must have adequate hepatic, renal, and bone marrow function;
boolean
C0193867 (UMLS CUI [1])
C0796693 (UMLS CUI [2])
C0796693 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0398442 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0193847 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
C0193867 (UMLS CUI [6])
C0428772 (UMLS CUI [7,1])
C0013516 (UMLS CUI [7,2])
C0428772 (UMLS CUI [8,1])
C0521317 (UMLS CUI [8,2])
C0232741 (UMLS CUI [9])
C0232804 (UMLS CUI [10])
C0005953 (UMLS CUI [11,1])
C0031843 (UMLS CUI [11,2])
Bone Marrow function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
bone marrow function hb: ≥ 10.0 g/dl anc: ≥ 1,500/µl platelet count: ≥ 10 × 10⁴/µl
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
renal function creatinine: ≤ 1.5 × unl or creatine clearance (ccr) >50 ml/min by the cockcroft formula
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Protocol Compliance
Item
hepatic function total bilirubin: ≤ 1.5 × unl ast/alt: ≤ 2.5 × unl 10) ability and willingness to comply with the study visits, treatment, testing, and with the protocol, as per investigator's judgment
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0525058 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Primary invasive malignant neoplasm of female breast
Item
1. any prior systemic treatment for primary invasive breast cancer
boolean
C1515119 (UMLS CUI [1,1])
C4076461 (UMLS CUI [1,2])
Neoplasm TNM Breast tumor staging | Inflammatory Breast Carcinoma
Item
2. ct4 or pt4 tumors including inflammatory breast cancer
boolean
C0027651 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0278601 (UMLS CUI [2])
Occult Breast Carcinoma
Item
3. occult breast cancer
boolean
C4527188 (UMLS CUI [1])
Secondary malignant neoplasm of female breast
Item
4. evidence of metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Second Primary Cancer | Exception Skin carcinoma Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception DCIS | Exception Thyroid carcinoma Size | Exception Papillary thyroid carcinoma | Exception Follicular thyroid carcinoma | Exception Medullary carcinoma of thyroid | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration
Item
5. patients with second primary cancer; exceptions: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, dcis of the breast, thyroid cancer with a size of <2 cm (papillary, follicular, and medullary type), and other solid tumors curatively treated with no evidence of disease for >5 years prior to randomization.
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007124 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0549473 (UMLS CUI [5,2])
C0456389 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0238463 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0206682 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0238462 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C1273390 (UMLS CUI [9,2])
C0280100 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0012634 (UMLS CUI [10,2])
C0332296 (UMLS CUI [10,3])
C0449238 (UMLS CUI [10,4])
Bilateral breast cancer
Item
6. simultaneous bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Low Risk Disease Serious Uncontrolled | Low Risk Communicable Disease Uncontrolled
Item
7. patients considered a poor medical risk due to a serious, uncontrolled medical disorder or uncontrolled infection.
boolean
C3538919 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0205318 (UMLS CUI [1,4])
C3538919 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
8. pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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