ID

37749

Description

Oral Microencapsulated Diindolylmethane in Treating Patients With Stage II-III Triple Negative, Androgen Receptor Positive Breast Cancer Who Have Undergone Chemotherapy and Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT01612910

Link

https://clinicaltrials.gov/show/NCT01612910

Keywords

Versions (1)
  1. 8/21/19 8/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer Female NCT01612910

English

Eligibility Breast Cancer Female NCT01612910

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with a histologically or pathologically confirmed diagnosis of triple negative, ar positive invasive breast carcinoma (stage ii or iii) who have received neoadjuvant chemotherapy (anthracycline or taxane or both) who have residual disease in their breasts following surgical resection by lumpectomy or mastectomy; androgen receptor (ar) testing will be performed on all patients who have residual invasive breast cancer after neoadjuvant taxane and/or anthracycline for triple negative breast cancer; this will be done under institutional protocol approval; physicians of patients who have ar positive tumors will be notified by our research coordinator of the potential eligibility for this study
Description

Triple Negative Breast Neoplasm Androgen Receptor Positive Invasive TNM Breast tumor staging | Neoadjuvant Chemotherapy | Anthracycline | taxane | Residual disease Breast | Status post Excision | Lumpectomy | Mastectomy | Androgen Receptor Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C2986463
UMLS CUI [1,3]
C0205281
UMLS CUI [1,4]
C0474926
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [3]
C0282564
UMLS CUI [4]
C0215136
UMLS CUI [5,1]
C0543478
UMLS CUI [5,2]
C0006141
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C0728940
UMLS CUI [7]
C0851238
UMLS CUI [8]
C0024881
UMLS CUI [9,1]
C0034786
UMLS CUI [9,2]
C0039593
participants must have undergone definitive surgery with negative margins for breast cancer in the past 2 years and must have residual pathologic invasive disease in the primary breast or lymph nodes or both; at the time of protocol entry it will be determined under good medical practice that there is no evidence for metastatic disease; patients should have completed all radiation therapy if indicated at the time of study entry
Description

Operative Surgical Procedure | Negative Surgical Margins Breast Carcinoma | Residual disease Invasive Breast | Residual disease Invasive Lymph nodes | Neoplasm Metastasis Absent | Therapeutic radiology procedure Completed

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C1709157
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0543478
UMLS CUI [3,2]
C0205281
UMLS CUI [3,3]
C0006141
UMLS CUI [4,1]
C0543478
UMLS CUI [4,2]
C0205281
UMLS CUI [4,3]
C0024204
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0205197
patients must have a zubrod performance status of 0-2
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
patients must consent to the serum and whole blood specimen submissions
Description

Serum specimen Submission | Whole blood sample Submission

Data type

boolean

Alias
UMLS CUI [1,1]
C1550100
UMLS CUI [1,2]
C1515022
UMLS CUI [2,1]
C0444256
UMLS CUI [2,2]
C1515022
patients must be able to take oral medications (patients with uncontrolled nausea, vomiting, diarrhea at baseline, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, are excluded)
Description

Able to swallow Oral medication | Nausea Uncontrolled Excluded | Vomiting Excluded | Diarrhea Excluded | Lack Integrity Upper gastrointestinal tract Excluded | Malabsorption Syndrome Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0027497
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0042963
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C0011991
UMLS CUI [4,2]
C0332196
UMLS CUI [5,1]
C0332268
UMLS CUI [5,2]
C1947912
UMLS CUI [5,3]
C1268997
UMLS CUI [5,4]
C0332196
UMLS CUI [6,1]
C0024523
UMLS CUI [6,2]
C0332196
pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of this trial
Description

Pregnancy | Breast Feeding | 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]
C0700589
patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
granulocyte count > 1,500/mcl
Description

Granulocyte count

Data type

boolean

Alias
UMLS CUI [1]
C0857490
platelet count > 100,000/mcl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin =< 3 x institutional upper limit of normal (iuln)
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
aspartate aminotransferase (ast)/alanine aminotransferase (alt) =< 5 x iuln
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine =< 1.5 x iuln
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have a current active infection requiring systemic therapy
Description

Communicable Disease Requirement Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
patients must not have had a cardiac event within 6 months prior to registration such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic congestive heart failure (chf), cerebrovascular accident or transient ischemic attack, or pulmonary embolism
Description

Cardiac event | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0741923
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0010055
UMLS CUI [6]
C3495795
UMLS CUI [7]
C0742758
UMLS CUI [8]
C0038454
UMLS CUI [9]
C0007787
UMLS CUI [10]
C0034065
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Similar models

Eligibility Breast Cancer Female NCT01612910

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Triple Negative Breast Neoplasm Androgen Receptor Positive Invasive TNM Breast tumor staging | Neoadjuvant Chemotherapy | Anthracycline | taxane | Residual disease Breast | Status post Excision | Lumpectomy | Mastectomy | Androgen Receptor Testing
Item
participants with a histologically or pathologically confirmed diagnosis of triple negative, ar positive invasive breast carcinoma (stage ii or iii) who have received neoadjuvant chemotherapy (anthracycline or taxane or both) who have residual disease in their breasts following surgical resection by lumpectomy or mastectomy; androgen receptor (ar) testing will be performed on all patients who have residual invasive breast cancer after neoadjuvant taxane and/or anthracycline for triple negative breast cancer; this will be done under institutional protocol approval; physicians of patients who have ar positive tumors will be notified by our research coordinator of the potential eligibility for this study
boolean
C3539878 (UMLS CUI [1,1])
C2986463 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0282564 (UMLS CUI [3])
C0215136 (UMLS CUI [4])
C0543478 (UMLS CUI [5,1])
C0006141 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C0728940 (UMLS CUI [6,2])
C0851238 (UMLS CUI [7])
C0024881 (UMLS CUI [8])
C0034786 (UMLS CUI [9,1])
C0039593 (UMLS CUI [9,2])
Operative Surgical Procedure | Negative Surgical Margins Breast Carcinoma | Residual disease Invasive Breast | Residual disease Invasive Lymph nodes | Neoplasm Metastasis Absent | Therapeutic radiology procedure Completed
Item
participants must have undergone definitive surgery with negative margins for breast cancer in the past 2 years and must have residual pathologic invasive disease in the primary breast or lymph nodes or both; at the time of protocol entry it will be determined under good medical practice that there is no evidence for metastatic disease; patients should have completed all radiation therapy if indicated at the time of study entry
boolean
C0543467 (UMLS CUI [1])
C1709157 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0543478 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0006141 (UMLS CUI [3,3])
C0543478 (UMLS CUI [4,1])
C0205281 (UMLS CUI [4,2])
C0024204 (UMLS CUI [4,3])
C0027627 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
Zubrod Performance Status
Item
patients must have a zubrod performance status of 0-2
boolean
C3714786 (UMLS CUI [1])
Serum specimen Submission | Whole blood sample Submission
Item
patients must consent to the serum and whole blood specimen submissions
boolean
C1550100 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
C0444256 (UMLS CUI [2,1])
C1515022 (UMLS CUI [2,2])
Able to swallow Oral medication | Nausea Uncontrolled Excluded | Vomiting Excluded | Diarrhea Excluded | Lack Integrity Upper gastrointestinal tract Excluded | Malabsorption Syndrome Excluded
Item
patients must be able to take oral medications (patients with uncontrolled nausea, vomiting, diarrhea at baseline, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, are excluded)
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0042963 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0011991 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0332268 (UMLS CUI [5,1])
C1947912 (UMLS CUI [5,2])
C1268997 (UMLS CUI [5,3])
C0332196 (UMLS CUI [5,4])
C0024523 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of this trial
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Granulocyte count
Item
granulocyte count > 1,500/mcl
boolean
C0857490 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100,000/mcl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin =< 3 x institutional upper limit of normal (iuln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast)/alanine aminotransferase (alt) =< 5 x iuln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine =< 1.5 x iuln
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Requirement Systemic therapy
Item
patients must not have a current active infection requiring systemic therapy
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Cardiac event | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism
Item
patients must not have had a cardiac event within 6 months prior to registration such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic congestive heart failure (chf), cerebrovascular accident or transient ischemic attack, or pulmonary embolism
boolean
C0741923 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C3495795 (UMLS CUI [6])
C0742758 (UMLS CUI [7])
C0038454 (UMLS CUI [8])
C0007787 (UMLS CUI [9])
C0034065 (UMLS CUI [10])
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