ID

27319

Description

Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00546364

Link

https://clinicaltrials.gov/show/NCT00546364

Keywords

Versions (1)
  1. 11/8/17 11/8/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 8, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00546364

English

Eligibility Breast Neoplasms NCT00546364

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with metastatic breast cancer
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
measurable disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
up to 1 chemotherapy regimen is acceptable. participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. there is no timeframe for prior paclitaxel in the metastatic setting.
Description

Chemotherapy Regimen Quantity | Paclitaxel Neoadjuvant Therapy | Paclitaxel Adjuvant therapy | Absence Paclitaxel Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0144576
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C0144576
UMLS CUI [3,2]
C0677850
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0144576
UMLS CUI [4,3]
C0027627
human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
Description

Study Subject HER2/Neu Positive | Disease Progression | trastuzumab | lapatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C2348909
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0728747
UMLS CUI [4]
C1506770
eastern cooperative oncology group performance status of 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age younger than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 1 chemotherapy regimen for the treatment of metastatic breast cancer
Description

Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
prior treatment with any epothilone, capecitabine, or docetaxel
Description

Epothilones | capecitabine | docetaxel

Data type

boolean

Alias
UMLS CUI [1]
C1136012
UMLS CUI [2]
C0671970
UMLS CUI [3]
C0246415
prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). if prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. there must be at least 1 week between focal/palliative radiation and administration of study medication.
Description

Prior radiation therapy Bone Marrow Percentage | Prior radiation therapy Pelvis | Prior radiation therapy Lumbar spine | Therapeutic radiology procedure Focal | Palliative Radiation Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0030797
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C3887615
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205234
UMLS CUI [5]
C3898008
any current or previous history of brain and/or leptomeningeal metastases
Description

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
neuropathy greater than grade 2
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
Description

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
uncontrolled diabetes mellitus
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
chronic hepatitis
Description

Hepatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0019189
hiv-positive status
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. hormonal anticancer agents must be discontinued at least 14 days prior to study medication. hormonal replacement therapy is acceptable
Description

Trastuzumab To be stopped | Lapatinib To be stopped | Bevacizumab To be stopped | Systemic therapy To be stopped Malignant Neoplasms | Hormonal Antineoplastic Agents To be stopped | Hormone replacement therapy Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C1506770
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0796392
UMLS CUI [3,2]
C1272691
UMLS CUI [4,1]
C1515119
UMLS CUI [4,2]
C1272691
UMLS CUI [4,3]
C0006826
UMLS CUI [5,1]
C0282559
UMLS CUI [5,2]
C1272691
UMLS CUI [6,1]
C0282402
UMLS CUI [6,2]
C1879533
biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry
Description

Diphosphonates allowed Palliative Care Secondary malignant neoplasm of bone

Data type

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C0030231
UMLS CUI [1,4]
C0153690
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Similar models

Eligibility Breast Neoplasms NCT00546364

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
participants with metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Chemotherapy Regimen Quantity | Paclitaxel Neoadjuvant Therapy | Paclitaxel Adjuvant therapy | Absence Paclitaxel Neoplasm Metastasis
Item
up to 1 chemotherapy regimen is acceptable. participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. there is no timeframe for prior paclitaxel in the metastatic setting.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0144576 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0144576 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0144576 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
Study Subject HER2/Neu Positive | Disease Progression | trastuzumab | lapatinib
Item
human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
boolean
C0681850 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0728747 (UMLS CUI [3])
C1506770 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age younger than 18 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast
Item
more than 1 chemotherapy regimen for the treatment of metastatic breast cancer
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Epothilones | capecitabine | docetaxel
Item
prior treatment with any epothilone, capecitabine, or docetaxel
boolean
C1136012 (UMLS CUI [1])
C0671970 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
Prior radiation therapy Bone Marrow Percentage | Prior radiation therapy Pelvis | Prior radiation therapy Lumbar spine | Therapeutic radiology procedure Focal | Palliative Radiation Therapy
Item
prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). if prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. there must be at least 1 week between focal/palliative radiation and administration of study medication.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C3887615 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0205234 (UMLS CUI [4,2])
C3898008 (UMLS CUI [5])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
any current or previous history of brain and/or leptomeningeal metastases
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Neuropathy CTCAE Grades
Item
neuropathy greater than grade 2
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Diabetic - poor control
Item
uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Hepatitis, Chronic
Item
chronic hepatitis
boolean
C0019189 (UMLS CUI [1])
HIV Seropositivity
Item
hiv-positive status
boolean
C0019699 (UMLS CUI [1])
Trastuzumab To be stopped | Lapatinib To be stopped | Bevacizumab To be stopped | Systemic therapy To be stopped Malignant Neoplasms | Hormonal Antineoplastic Agents To be stopped | Hormone replacement therapy Acceptable
Item
administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. hormonal anticancer agents must be discontinued at least 14 days prior to study medication. hormonal replacement therapy is acceptable
boolean
C0728747 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C1506770 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0796392 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C1515119 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
C0006826 (UMLS CUI [4,3])
C0282559 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
C0282402 (UMLS CUI [6,1])
C1879533 (UMLS CUI [6,2])
Diphosphonates allowed Palliative Care Secondary malignant neoplasm of bone
Item
biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry
boolean
C0012544 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0030231 (UMLS CUI [1,3])
C0153690 (UMLS CUI [1,4])
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