ID

26013

Description

Clinical Trial of SAHA in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00416130

Link

https://clinicaltrials.gov/show/NCT00416130

Keywords

Versions (2)
  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00416130

English

Eligibility Breast Cancer NCT00416130

1 forms  
Criteria
Description

Criteria

cytologically or histologically confirmed adenocarcinoma of the breast that is recurrent and/or metastatic
Description

Breast adenocarcinoma recurrent | Breast adenocarcinoma metastatic

Data type

boolean

Alias
UMLS CUI [1]
C0861355
UMLS CUI [2]
C1697918
must have measurable disease as defined by recist criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
no more than 2 prior chemotherapy for recurrent and/or metastatic disease excluding neoadjuvant or adjuvant chemotherapy
Description

Chemotherapy Quantity Recurrent disease | Chemotherapy Quantity Neoplasm Metastasis | Exception Chemotherapy Neoadjuvant | Exception Adjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0600558
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0085533
previously received anthracycline- and taxane-containing chemotherapy for treatment of breast cancer in the neoadjuvant, adjuvant, or metastatic setting
Description

Chemotherapy Containing Anthracyclines | Chemotherapy Containing Taxane | Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0282564
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0215136
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0678222
UMLS CUI [5]
C0346993
must be able to swallow capsules
Description

Able to swallow capsules

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
adequate bone marrow reserve and liver function
Description

Mature Neutrophils Present Bone Marrow Complete | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C1708947
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0232741
women in reproductive age group must agree to practice effective contraception during the entire study period unless documentation of infertility exists.
Description

Childbearing Potential Contraceptive methods | Exception Documentation Infertility

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0175636
UMLS CUI [2,3]
C0021359
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
prior treatment with any hdac inhibitor. patients who have received such agents for other indications, e.g. epilepsy, may enroll in the trial after a 30 day washout period.
Description

Histone deacetylase inhibitor | Histone deacetylase inhibitor Epilepsy allowed

Data type

boolean

Alias
UMLS CUI [1]
C1512474
UMLS CUI [2,1]
C1512474
UMLS CUI [2,2]
C0014544
UMLS CUI [2,3]
C0683607
known cns involvement by tumor
Description

Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1]
C4050309
concurrent use of oral retinoids or any vitamin a, other than a single multivitamin tablet daily
Description

Retinoids Oral | Vitamin A | Exception Daily Multivitamin Oral Tablet

Data type

boolean

Alias
UMLS CUI [1,1]
C0035339
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0042839
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0976064
acute infection requiring intravenous antibiotics or antifungal agents,known hiv infection, active hepatitis b and/or hepatitis c infection
Description

Communicable Disease Requirement Intravenous antibiotic therapy | Communicable Disease Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0559680
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003308
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
uncontrolled intercurrent illness
Description

Comorbidity Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
cancer other than breast cancer with the exception of basal cell carcinoma or disease that has been in remission for ≥5 years
Description

Malignant Neoplasms | Exception Breast Carcinoma | Exception Basal cell carcinoma | Exception Disease remission Duration

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0544452
UMLS CUI [4,3]
C0449238
pregnant or lactating 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 NCT00416130

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast adenocarcinoma recurrent | Breast adenocarcinoma metastatic
Item
cytologically or histologically confirmed adenocarcinoma of the breast that is recurrent and/or metastatic
boolean
C0861355 (UMLS CUI [1])
C1697918 (UMLS CUI [2])
Measurable Disease
Item
must have measurable disease as defined by recist criteria
boolean
C1513041 (UMLS CUI [1])
Chemotherapy Quantity Recurrent disease | Chemotherapy Quantity Neoplasm Metastasis | Exception Chemotherapy Neoadjuvant | Exception Adjuvant Chemotherapy
Item
no more than 2 prior chemotherapy for recurrent and/or metastatic disease excluding neoadjuvant or adjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0085533 (UMLS CUI [4,2])
Chemotherapy Containing Anthracyclines | Chemotherapy Containing Taxane | Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | Secondary malignant neoplasm of female breast
Item
previously received anthracycline- and taxane-containing chemotherapy for treatment of breast cancer in the neoadjuvant, adjuvant, or metastatic setting
boolean
C0392920 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0282564 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0215136 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0346993 (UMLS CUI [5])
Able to swallow capsules
Item
must be able to swallow capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Mature Neutrophils Present Bone Marrow Complete | Liver function
Item
adequate bone marrow reserve and liver function
boolean
C1708947 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Exception Documentation Infertility
Item
women in reproductive age group must agree to practice effective contraception during the entire study period unless documentation of infertility exists.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0175636 (UMLS CUI [2,2])
C0021359 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Histone deacetylase inhibitor | Histone deacetylase inhibitor Epilepsy allowed
Item
prior treatment with any hdac inhibitor. patients who have received such agents for other indications, e.g. epilepsy, may enroll in the trial after a 30 day washout period.
boolean
C1512474 (UMLS CUI [1])
C1512474 (UMLS CUI [2,1])
C0014544 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Central Nervous System Involvement
Item
known cns involvement by tumor
boolean
C4050309 (UMLS CUI [1])
Retinoids Oral | Vitamin A | Exception Daily Multivitamin Oral Tablet
Item
concurrent use of oral retinoids or any vitamin a, other than a single multivitamin tablet daily
boolean
C0035339 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0042839 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0976064 (UMLS CUI [3,2])
Communicable Disease Requirement Intravenous antibiotic therapy | Communicable Disease Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C
Item
acute infection requiring intravenous antibiotics or antifungal agents,known hiv infection, active hepatitis b and/or hepatitis c infection
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0559680 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003308 (UMLS CUI [2,3])
C0019693 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Basal cell carcinoma | Exception Disease remission Duration
Item
cancer other than breast cancer with the exception of basal cell carcinoma or disease that has been in remission for ≥5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0544452 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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