ID

44558

Description

Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01044485

Link

https://clinicaltrials.gov/show/NCT01044485

Keywords

Versions (2)
  1. 6/18/18 6/18/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT01044485

English

Eligibility Metastatic Breast Cancer NCT01044485

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age over or equal 18 years·
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 to 2·
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients with histological or cytological confirmed breast cancer, her positive (ihc 3+, or ihc 2+ and fish/cish +, or fish+ or cish+ only), not amenable for an alternative curative strategy in first line metastatic setting·
Description

HER-2 positive breast cancer Immunohistochemistry | FISH | CISH | Curative treatment Unsuccessful Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0021044
UMLS CUI [2]
C0162789
UMLS CUI [3]
C1516514
UMLS CUI [4,1]
C1273390
UMLS CUI [4,2]
C1272705
UMLS CUI [4,3]
C0027627
patients who receive hormonotherapy for metastatic disease or who received chemotherapy in adjuvant setting if recurrence occur after 6 months are eligible·
Description

Hormone Therapy Neoplasm Metastasis | Adjuvant Chemotherapy Recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C2825055
patient must have not received the last injection of trastuzumab within the six weeks·
Description

Trastuzumab Injection Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C0332197
subjects must have completed prior radiotherapy treatment at least 4 weeks from enrolment and recovered from all treatment-related toxicities· subjects must have tissue available to prospectively determine treatment assignment and to compare tumor response with intra-tumor expression levels of relevant biomarkers·
Description

Prior radiation therapy Completed | Toxicity due to radiotherapy Patient recovered | Availability of Tissue specimen | Tumor Biomarkers Expression level

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1302210
UMLS CUI [2,2]
C1115804
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C1292533
UMLS CUI [4,1]
C0041366
UMLS CUI [4,2]
C3244092
no prior systemic investigational agent within the past 30 days or topical investigational drugs within the past 7 days·
Description

Investigational New Drugs Systemic Absent | Investigational New Drugs Topical Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1522168
UMLS CUI [2,3]
C0332197
subjects must have a cardiac ejection fraction within the institutional range of normal as measured by echo (echocardiogram) or muga (multigated acquisition) scan·
Description

Cardiac ejection fraction Normal Echocardiography | Cardiac ejection fraction Normal MUGA scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0205307
UMLS CUI [2,3]
C0521317
subjects must have adequate haematological, hepatic, and renal function·
Description

Hematologic function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
affiliation to a social insurance program is required
Description

Social security recipient

Data type

boolean

Alias
UMLS CUI [1]
C0682299
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with elevations of transaminase (alt and/or ast) greater than 2.5 times the upper limit of the normal range (uln) are not eligible for the study·
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier·
Description

Chemotherapy Recent | Therapeutic radiology procedure Recent | Nitrosoureas | Mitomycin | Adverse reaction to drug Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5,1]
C0041755
UMLS CUI [5,2]
C2004454
UMLS CUI [5,3]
C0332268
patients who have had prior treatment with egfr targeting therapies· all herbal (alternative) medicines are excluded·
Description

EGFR Targeted Therapy | Herbal medicine

Data type

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C2985566
UMLS CUI [2]
C2240391
patients with known brain metastases·
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.·
Description

Allergic Reaction Lapatinib Compound Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C1706082
UMLS CUI [1,4]
C2348205
uncontrolled inter-current illness including, but not limited to, ongoing or active infection, peripheral neuropathy of grade 2 or greater, or psychiatric illness/social situations that would limit compliance with study requirements·
Description

Comorbidity | Communicable Disease | Peripheral Neuropathy CTCAE Grades | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0031117
UMLS CUI [3,2]
C1516728
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0439801
UMLS CUI [5,1]
C0748872
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C0439801
pregnant women are excluded from this study because lapatinib is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects·
Description

Pregnancy | Lapatinib At risk Teratogenesis | Lapatinib At risk Abortifacient Effect

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1506770
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0232910
UMLS CUI [3,1]
C1506770
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C3179338
hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib·
Description

Antiretroviral combinations HIV Seropositivity | At risk Pharmacokinetic interaction Lapatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C2193864
UMLS CUI [1,2]
C0019699
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C1868980
UMLS CUI [2,3]
C1506770
patients with gastro intestinal (gi) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for iv alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory gi disease (e.g., crohn's, ulcerative colitis)· current active hepatic or biliary disease (with exception of patients with gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)· previous allergic reaction to docetaxel and/or polyascorbate· concomitant requirement for medication classified as cyp3a4 inducers or inhibitors·
Description

Gastrointestinal Diseases | Lacking Able to swallow Oral medication | Malabsorption Syndrome | Patient need for Intravenous Feeding | Operative Surgical Procedures Affecting Absorption | Gastrointestinal inflammatory disorders Uncontrolled | Crohn Disease | Ulcerative Colitis | Liver diseases | Biliary System Disorder | Exception Gilbert Disease | Exception Biliary calculi Asymptomatic | Exception Secondary malignant neoplasm of liver | Exception Chronic liver disease Stable | Allergic Reaction Docetaxel | Other Coding | CYP3A4 Inducer | CYP3A4 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712086
UMLS CUI [2,3]
C0175795
UMLS CUI [3]
C0024523
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0021910
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0237442
UMLS CUI [6,1]
C0851956
UMLS CUI [6,2]
C0205318
UMLS CUI [7]
C0010346
UMLS CUI [8]
C0009324
UMLS CUI [9]
C0023895
UMLS CUI [10]
C3275124
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0017551
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0242216
UMLS CUI [12,3]
C0231221
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0494165
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0341439
UMLS CUI [14,3]
C0205360
UMLS CUI [15,1]
C1527304
UMLS CUI [15,2]
C0246415
UMLS CUI [16]
C3846158
UMLS CUI [17]
C3830625
UMLS CUI [18]
C3850053
active cardiac disease, defined as: history of uncontrolled or symptomatic angina pectoris, history of cardiac arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation, myocardial infarction < 6 months from study entry, uncontrolled or symptomatic congestive heart failure, ejection fraction below the institutional normal limit
Description

Heart Diseases | Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia Requirement Pharmaceutical Preparations | Exception ATRIAL FIBRILLATION ASYMPTOMATIC Requirement Anticoagulation Therapy | Exception Myocardial Infarction | Exception Congestive heart failure Uncontrolled | Exception Symptomatic congestive heart failure | Exception Decreased cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0013227
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0741277
UMLS CUI [5,3]
C1514873
UMLS CUI [5,4]
C0003281
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0027051
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0018802
UMLS CUI [7,3]
C0205318
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0742758
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C3661817
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Similar models

Eligibility Metastatic Breast Cancer NCT01044485

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age over or equal 18 years·
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 to 2·
boolean
C1520224 (UMLS CUI [1])
HER-2 positive breast cancer Immunohistochemistry | FISH | CISH | Curative treatment Unsuccessful Neoplasm Metastasis
Item
patients with histological or cytological confirmed breast cancer, her positive (ihc 3+, or ihc 2+ and fish/cish +, or fish+ or cish+ only), not amenable for an alternative curative strategy in first line metastatic setting·
boolean
C1960398 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0162789 (UMLS CUI [2])
C1516514 (UMLS CUI [3])
C1273390 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
Hormone Therapy Neoplasm Metastasis | Adjuvant Chemotherapy Recurrence
Item
patients who receive hormonotherapy for metastatic disease or who received chemotherapy in adjuvant setting if recurrence occur after 6 months are eligible·
boolean
C0279025 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2,1])
C2825055 (UMLS CUI [2,2])
Trastuzumab Injection Absent
Item
patient must have not received the last injection of trastuzumab within the six weeks·
boolean
C0728747 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Prior radiation therapy Completed | Toxicity due to radiotherapy Patient recovered | Availability of Tissue specimen | Tumor Biomarkers Expression level
Item
subjects must have completed prior radiotherapy treatment at least 4 weeks from enrolment and recovered from all treatment-related toxicities· subjects must have tissue available to prospectively determine treatment assignment and to compare tumor response with intra-tumor expression levels of relevant biomarkers·
boolean
C0279134 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1302210 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
C0470187 (UMLS CUI [3,1])
C1292533 (UMLS CUI [3,2])
C0041366 (UMLS CUI [4,1])
C3244092 (UMLS CUI [4,2])
Investigational New Drugs Systemic Absent | Investigational New Drugs Topical Absent
Item
no prior systemic investigational agent within the past 30 days or topical investigational drugs within the past 7 days·
boolean
C0013230 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Cardiac ejection fraction Normal Echocardiography | Cardiac ejection fraction Normal MUGA scan
Item
subjects must have a cardiac ejection fraction within the institutional range of normal as measured by echo (echocardiogram) or muga (multigated acquisition) scan·
boolean
C0232174 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
C0232174 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0521317 (UMLS CUI [2,3])
Hematologic function | Liver function | Renal function
Item
subjects must have adequate haematological, hepatic, and renal function·
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Social security recipient
Item
affiliation to a social insurance program is required
boolean
C0682299 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
subjects with elevations of transaminase (alt and/or ast) greater than 2.5 times the upper limit of the normal range (uln) are not eligible for the study·
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Chemotherapy Recent | Therapeutic radiology procedure Recent | Nitrosoureas | Mitomycin | Adverse reaction to drug Recovery Lacking
Item
patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier·
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0041755 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
EGFR Targeted Therapy | Herbal medicine
Item
patients who have had prior treatment with egfr targeting therapies· all herbal (alternative) medicines are excluded·
boolean
C0034802 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C2240391 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
patients with known brain metastases·
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Lapatinib Compound Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.·
boolean
C1527304 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Comorbidity | Communicable Disease | Peripheral Neuropathy CTCAE Grades | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled inter-current illness including, but not limited to, ongoing or active infection, peripheral neuropathy of grade 2 or greater, or psychiatric illness/social situations that would limit compliance with study requirements·
boolean
C0009488 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0031117 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
Pregnancy | Lapatinib At risk Teratogenesis | Lapatinib At risk Abortifacient Effect
Item
pregnant women are excluded from this study because lapatinib is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects·
boolean
C0032961 (UMLS CUI [1])
C1506770 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0232910 (UMLS CUI [2,3])
C1506770 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C3179338 (UMLS CUI [3,3])
Antiretroviral combinations HIV Seropositivity | At risk Pharmacokinetic interaction Lapatinib
Item
hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib·
boolean
C2193864 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C1868980 (UMLS CUI [2,2])
C1506770 (UMLS CUI [2,3])
Gastrointestinal Diseases | Lacking Able to swallow Oral medication | Malabsorption Syndrome | Patient need for Intravenous Feeding | Operative Surgical Procedures Affecting Absorption | Gastrointestinal inflammatory disorders Uncontrolled | Crohn Disease | Ulcerative Colitis | Liver diseases | Biliary System Disorder | Exception Gilbert Disease | Exception Biliary calculi Asymptomatic | Exception Secondary malignant neoplasm of liver | Exception Chronic liver disease Stable | Allergic Reaction Docetaxel | Other Coding | CYP3A4 Inducer | CYP3A4 Inhibitors
Item
patients with gastro intestinal (gi) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for iv alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory gi disease (e.g., crohn's, ulcerative colitis)· current active hepatic or biliary disease (with exception of patients with gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)· previous allergic reaction to docetaxel and/or polyascorbate· concomitant requirement for medication classified as cyp3a4 inducers or inhibitors·
boolean
C0017178 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C2712086 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
C0024523 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0021910 (UMLS CUI [4,2])
C0543467 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C0851956 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0010346 (UMLS CUI [7])
C0009324 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C3275124 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0017551 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C0242216 (UMLS CUI [12,2])
C0231221 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0494165 (UMLS CUI [13,2])
C1705847 (UMLS CUI [14,1])
C0341439 (UMLS CUI [14,2])
C0205360 (UMLS CUI [14,3])
C1527304 (UMLS CUI [15,1])
C0246415 (UMLS CUI [15,2])
C3846158 (UMLS CUI [16])
C3830625 (UMLS CUI [17])
C3850053 (UMLS CUI [18])
Heart Diseases | Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia Requirement Pharmaceutical Preparations | Exception ATRIAL FIBRILLATION ASYMPTOMATIC Requirement Anticoagulation Therapy | Exception Myocardial Infarction | Exception Congestive heart failure Uncontrolled | Exception Symptomatic congestive heart failure | Exception Decreased cardiac ejection fraction
Item
active cardiac disease, defined as: history of uncontrolled or symptomatic angina pectoris, history of cardiac arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation, myocardial infarction < 6 months from study entry, uncontrolled or symptomatic congestive heart failure, ejection fraction below the institutional normal limit
boolean
C0018799 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0741277 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
C0003281 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0027051 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0018802 (UMLS CUI [7,2])
C0205318 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0742758 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C3661817 (UMLS CUI [9,2])
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