ID

37428

Beskrivning

A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02032277

Länk

https://clinicaltrials.gov/show/NCT02032277

Nyckelord

Versioner (1)
  1. 2019-07-25 2019-07-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Triple Negative Breast Cancer NCT02032277

Engelsk

Eligibility Triple Negative Breast Cancer NCT02032277

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). tumors must be clinical stage t2-3 n0-2 or t1 n1-2 per ajcc staging edition 7 or clinical stage t2-3 n0-2 or t1 n1-2 by physical exam or radiologic studies.
Beskrivning

Invasive carcinoma of breast Core needle biopsy | Invasive carcinoma of breast Incisional biopsy | Neoplasms TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0184922
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0474926
2. documented breast cancer gene (brca) germline mutation testing.
Beskrivning

BRCA gene Germ-Line Mutation Testing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0596223
UMLS CUI [1,2]
C0206530
UMLS CUI [1,3]
C0039593
3. estrogen receptor (er)-, progesterone receptor (pr)-, and human epidermal growth factor receptor (her)2-negative (triple-negative) cancer of the breast.
Beskrivning

Triple Negative Breast Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C3539878
4. ecog performance status of 0 to 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the investigator or they must have a negative serum pregnancy test prior to randomization.
Beskrivning

Gender | Childbearing Potential Absent | Female Sterilization | Postmenopausal state | Childbearing Potential Serum pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0232970
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430061
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
Beskrivning

Cancer treatment Therapeutic intent Breast Carcinoma | Cytotoxic Chemotherapy | Immunotherapy | Biological treatment | Therapeutic radiology procedure | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0302350
UMLS CUI [1,3]
C0678222
UMLS CUI [2]
C0677881
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1531518
UMLS CUI [5]
C1522449
UMLS CUI [6]
C0013230
2. previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a poly-(adp-ribose)-polymerase (parp) inhibitor.
Beskrivning

Carboplatin | Paclitaxel | Doxorubicin | Cyclophosphamide | Poly(ADP-ribose) Polymerase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0079083
UMLS CUI [2]
C0144576
UMLS CUI [3]
C0013089
UMLS CUI [4]
C0010583
UMLS CUI [5]
C1882413
3. concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (serm). subjects must have discontinued use of such agents prior to beginning study treatment.
Beskrivning

Hormone replacement therapy ovarian | Pharmaceutical Preparations Hormonal To be stopped | Raloxifene | Tamoxifen | Selective Estrogen Receptor Modulators

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C0205065
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0458083
UMLS CUI [2,3]
C1272691
UMLS CUI [3]
C0244404
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0732611
4. a history of seizure within 12 months prior to study entry.
Beskrivning

Seizure

Datatyp

boolean

Alias
UMLS CUI [1]
C0036572
5. pre-existing neuropathy from any cause in excess of grade 1.
Beskrivning

Neuropathy Pre-existing CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
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Similar models

Eligibility Triple Negative Breast Cancer NCT02032277

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Core needle biopsy | Invasive carcinoma of breast Incisional biopsy | Neoplasms TNM Breast tumor staging
Item
1. histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). tumors must be clinical stage t2-3 n0-2 or t1 n1-2 per ajcc staging edition 7 or clinical stage t2-3 n0-2 or t1 n1-2 by physical exam or radiologic studies.
boolean
C0853879 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0184922 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
BRCA gene Germ-Line Mutation Testing
Item
2. documented breast cancer gene (brca) germline mutation testing.
boolean
C0596223 (UMLS CUI [1,1])
C0206530 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Triple Negative Breast Neoplasms
Item
3. estrogen receptor (er)-, progesterone receptor (pr)-, and human epidermal growth factor receptor (her)2-negative (triple-negative) cancer of the breast.
boolean
C3539878 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Gender | Childbearing Potential Absent | Female Sterilization | Postmenopausal state | Childbearing Potential Serum pregnancy test negative
Item
5. women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the investigator or they must have a negative serum pregnancy test prior to randomization.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Therapeutic intent Breast Carcinoma | Cytotoxic Chemotherapy | Immunotherapy | Biological treatment | Therapeutic radiology procedure | Investigational New Drugs
Item
1. previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
boolean
C0920425 (UMLS CUI [1,1])
C0302350 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
Carboplatin | Paclitaxel | Doxorubicin | Cyclophosphamide | Poly(ADP-ribose) Polymerase Inhibitors
Item
2. previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a poly-(adp-ribose)-polymerase (parp) inhibitor.
boolean
C0079083 (UMLS CUI [1])
C0144576 (UMLS CUI [2])
C0013089 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
C1882413 (UMLS CUI [5])
Hormone replacement therapy ovarian | Pharmaceutical Preparations Hormonal To be stopped | Raloxifene | Tamoxifen | Selective Estrogen Receptor Modulators
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). subjects must have discontinued use of such agents prior to beginning study treatment.
boolean
C0282402 (UMLS CUI [1,1])
C0205065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0458083 (UMLS CUI [2,2])
C1272691 (UMLS CUI [2,3])
C0244404 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
C0732611 (UMLS CUI [5])
Seizure
Item
4. a history of seizure within 12 months prior to study entry.
boolean
C0036572 (UMLS CUI [1])
Neuropathy Pre-existing CTCAE Grades
Item
5. pre-existing neuropathy from any cause in excess of grade 1.
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
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