ID

39636

Description

Therapeutic Estradiol and Exemestane in Treating Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01385280

Link

https://clinicaltrials.gov/show/NCT01385280

Keywords

Versions (2)
  1. 2/6/20 2/6/20 -
  2. 2/6/20 2/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 6, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Estrogen Receptor-positive Breast Cancer NCT01385280

English

Eligibility Estrogen Receptor-positive Breast Cancer NCT01385280

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
post-menopausal women with metastatic carcinoma of the breast; post-menopausal, as defined by at least one of the following: at least 12 months without spontaneous menstrual bleeding, history of bilateral salpingo-oophorectomy with or without hysterectomy, age > 55 with hysterectomy with or without oophorectomy, serum fsh in post-menopausal range within 4 weeks of registration
Description

Postmenopausal state | Secondary malignant neoplasm of female breast | Menstruation absent Duration | Bilateral salpingectomy with oophorectomy | Hysterectomy | Hysterectomy Absent | Age | Ovariectomy | Ovariectomy Absent | Serum follicle stimulating hormone measurement Consistent with Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0346993
UMLS CUI [3,1]
C0497456
UMLS CUI [3,2]
C0449238
UMLS CUI [4]
C0195495
UMLS CUI [5]
C0020699
UMLS CUI [6,1]
C0020699
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C0001779
UMLS CUI [8]
C0029936
UMLS CUI [9,1]
C0029936
UMLS CUI [9,2]
C0332197
UMLS CUI [10,1]
C0455276
UMLS CUI [10,2]
C0332290
UMLS CUI [10,3]
C0232970
positive for estrogen receptor (er) or progesterone receptor (pgr) with positivity defined as immunohistochemical staining in >= 10% of cells
Description

Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0279754
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0279759
UMLS CUI [2,2]
C0021044
either measurable disease by recist or non-measurable evaluable disease; tests to evaluate disease (measurable and non-measurable) must be completed within 28 days prior to registration; these will include a ct scan of the chest/abdomen/pelvis and a bone scan; patients with effusions or ascites as the only sites of disease are ineligible
Description

Measurable Disease | Evaluable Disease Non-Measurable | Evaluation Completed | Chest CT | CT of abdomen | CT of Pelvis | Radioisotope scan of bone

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C1518373
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C0205197
UMLS CUI [4]
C0202823
UMLS CUI [5]
C0412620
UMLS CUI [6]
C0412628
UMLS CUI [7]
C0203668
performance status of 0-2 by zubrod criteria
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
patients must have a baseline ca15-3 or ca 27.29 measurement for future comparison, but any baseline value is acceptable
Description

CA 15-3 measurement | Cancer Antigen 27-29 Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201547
UMLS CUI [2]
C2919221
patients must have had prior aromatase inhibitor (ai) therapy in the metastatic setting (oneany number of prior ai is allowed, this may have been any of the ai's), or have developed metastatic disease on adjuvant ai therapy; prior treatment with tamoxifen and/or fulvestrant is also allowed; patients must not have been previously treated with estradiol for metastatic breast cancer
Description

Aromatase Inhibitors Neoplasm Metastasis | Aromatase Inhibitors Adjuvant therapy | Neoplasm Metastasis Development | Tamoxifen | fulvestrant | Estradiol Absent Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0593802
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0243107
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0935916
UMLS CUI [6,1]
C0014912
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0346993
patients must be able to take oral medications
Description

Able to swallow Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must consent to the serum and ctc blood specimen submissions
Description

Serum Specimen Submission | Circulating Neoplastic Cells Blood specimen Submission

Data type

boolean

Alias
UMLS CUI [1,1]
C1550100
UMLS CUI [1,2]
C1515022
UMLS CUI [2,1]
C0027625
UMLS CUI [2,2]
C0178913
UMLS CUI [2,3]
C1515022
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
planning to receive concomitant chemotherapy, hormone therapy (including hormone replacement therapy), radiation therapy, or antibody therapy for malignancy while receiving protocol treatment, with the single exception of trastuzumab; concomitant trastuzumab will be allowed for her-2 positive patients who were previously on trastuzumab; patients who have had previous radiotherapy must complete treatment within 4 weeks of registration, and have recovered from acute toxicity from radiation; patients with prior cytotoxic chemotherapy for metastatic disease will not be eligible
Description

Chemotherapy Malignant Neoplasms | Hormone Therapy Malignant Neoplasms | Hormone replacement therapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Antibody therapy Malignant Neoplasms | Exception Trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0282402
UMLS CUI [3,2]
C0006826
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0006826
UMLS CUI [5,1]
C0281176
UMLS CUI [5,2]
C0006826
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0728747
known hypersensitivity or intolerance to estradiol, aromatase inhibitors, or aspirin; patients must not have a history of aspirin-induced gi bleeding within the past 3 years
Description

Estradiol allergy | Intolerance to Estradiol | Hypersensitivity Aromatase Inhibitors | Intolerance to Aromatase Inhibitors | Aspirin allergy | Intolerance to Aspirin | Gastrointestinal Hemorrhage Due to Aspirin

Data type

boolean

Alias
UMLS CUI [1]
C0571688
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0014912
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0593802
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0593802
UMLS CUI [5]
C0004058
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0004057
UMLS CUI [7,1]
C0017181
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0004057
known untreated brain or cns metastases due to the risk of bleeding on aspirin during estradiol
Description

Metastatic malignant neoplasm to brain Untreated | CNS metastases Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0332155
history of deep vein thrombosis, pulmonary embolism, or other clot requiring anticoagulation; patients must not have a known inherited hypercoagulable disorder
Description

Deep Vein Thrombosis | Pulmonary Embolism | Clot Requirement Anticoagulation Therapy | Thrombophilia, hereditary

Data type

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
UMLS CUI [3,1]
C0302148
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0003281
UMLS CUI [4]
C2584620
history of decompensated congestive heart failure, unstable angina, or uncontrolled psychiatric illness which would limit compliance with the protocol treatment
Description

CONGESTIVE HEART FAILURE DECOMPENSATED Limiting Treatment Compliance | Unstable Angina Limiting Treatment Compliance | Mental disorders Uncontrolled Limiting Treatment Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0742746
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C4319828
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C4319828
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C4319828
prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Description

Malignant Neoplasm Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission | Exception Disease Free of Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C3258246
UMLS CUI [5,4]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C0677874
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0012634
UMLS CUI [7,3]
C0332296
UMLS CUI [7,4]
C0449238
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Similar models

Eligibility Estrogen Receptor-positive Breast Cancer NCT01385280

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Secondary malignant neoplasm of female breast | Menstruation absent Duration | Bilateral salpingectomy with oophorectomy | Hysterectomy | Hysterectomy Absent | Age | Ovariectomy | Ovariectomy Absent | Serum follicle stimulating hormone measurement Consistent with Postmenopausal state
Item
post-menopausal women with metastatic carcinoma of the breast; post-menopausal, as defined by at least one of the following: at least 12 months without spontaneous menstrual bleeding, history of bilateral salpingo-oophorectomy with or without hysterectomy, age > 55 with hysterectomy with or without oophorectomy, serum fsh in post-menopausal range within 4 weeks of registration
boolean
C0232970 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C0497456 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0195495 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0020699 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0001779 (UMLS CUI [7])
C0029936 (UMLS CUI [8])
C0029936 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0455276 (UMLS CUI [10,1])
C0332290 (UMLS CUI [10,2])
C0232970 (UMLS CUI [10,3])
Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry
Item
positive for estrogen receptor (er) or progesterone receptor (pgr) with positivity defined as immunohistochemical staining in >= 10% of cells
boolean
C0279754 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0279759 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease Non-Measurable | Evaluation Completed | Chest CT | CT of abdomen | CT of Pelvis | Radioisotope scan of bone
Item
either measurable disease by recist or non-measurable evaluable disease; tests to evaluate disease (measurable and non-measurable) must be completed within 28 days prior to registration; these will include a ct scan of the chest/abdomen/pelvis and a bone scan; patients with effusions or ascites as the only sites of disease are ineligible
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2,1])
C1518373 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0202823 (UMLS CUI [4])
C0412620 (UMLS CUI [5])
C0412628 (UMLS CUI [6])
C0203668 (UMLS CUI [7])
Zubrod Performance Status
Item
performance status of 0-2 by zubrod criteria
boolean
C3714786 (UMLS CUI [1])
CA 15-3 measurement | Cancer Antigen 27-29 Measurement
Item
patients must have a baseline ca15-3 or ca 27.29 measurement for future comparison, but any baseline value is acceptable
boolean
C0201547 (UMLS CUI [1])
C2919221 (UMLS CUI [2])
Aromatase Inhibitors Neoplasm Metastasis | Aromatase Inhibitors Adjuvant therapy | Neoplasm Metastasis Development | Tamoxifen | fulvestrant | Estradiol Absent Secondary malignant neoplasm of female breast
Item
patients must have had prior aromatase inhibitor (ai) therapy in the metastatic setting (oneany number of prior ai is allowed, this may have been any of the ai's), or have developed metastatic disease on adjuvant ai therapy; prior treatment with tamoxifen and/or fulvestrant is also allowed; patients must not have been previously treated with estradiol for metastatic breast cancer
boolean
C0593802 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0243107 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4])
C0935916 (UMLS CUI [5])
C0014912 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0346993 (UMLS CUI [6,3])
Able to swallow Oral medication
Item
patients must be able to take oral medications
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Informed Consent
Item
patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Serum Specimen Submission | Circulating Neoplastic Cells Blood specimen Submission
Item
patients must consent to the serum and ctc blood specimen submissions
boolean
C1550100 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
C0027625 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
C1515022 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Malignant Neoplasms | Hormone Therapy Malignant Neoplasms | Hormone replacement therapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Antibody therapy Malignant Neoplasms | Exception Trastuzumab
Item
planning to receive concomitant chemotherapy, hormone therapy (including hormone replacement therapy), radiation therapy, or antibody therapy for malignancy while receiving protocol treatment, with the single exception of trastuzumab; concomitant trastuzumab will be allowed for her-2 positive patients who were previously on trastuzumab; patients who have had previous radiotherapy must complete treatment within 4 weeks of registration, and have recovered from acute toxicity from radiation; patients with prior cytotoxic chemotherapy for metastatic disease will not be eligible
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0282402 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0281176 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0728747 (UMLS CUI [6,2])
Estradiol allergy | Intolerance to Estradiol | Hypersensitivity Aromatase Inhibitors | Intolerance to Aromatase Inhibitors | Aspirin allergy | Intolerance to Aspirin | Gastrointestinal Hemorrhage Due to Aspirin
Item
known hypersensitivity or intolerance to estradiol, aromatase inhibitors, or aspirin; patients must not have a history of aspirin-induced gi bleeding within the past 3 years
boolean
C0571688 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0014912 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0593802 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0593802 (UMLS CUI [4,2])
C0004058 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0004057 (UMLS CUI [6,2])
C0017181 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0004057 (UMLS CUI [7,3])
Metastatic malignant neoplasm to brain Untreated | CNS metastases Untreated
Item
known untreated brain or cns metastases due to the risk of bleeding on aspirin during estradiol
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Deep Vein Thrombosis | Pulmonary Embolism | Clot Requirement Anticoagulation Therapy | Thrombophilia, hereditary
Item
history of deep vein thrombosis, pulmonary embolism, or other clot requiring anticoagulation; patients must not have a known inherited hypercoagulable disorder
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0302148 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003281 (UMLS CUI [3,3])
C2584620 (UMLS CUI [4])
CONGESTIVE HEART FAILURE DECOMPENSATED Limiting Treatment Compliance | Unstable Angina Limiting Treatment Compliance | Mental disorders Uncontrolled Limiting Treatment Compliance
Item
history of decompensated congestive heart failure, unstable angina, or uncontrolled psychiatric illness which would limit compliance with the protocol treatment
boolean
C0742746 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C0002965 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C4319828 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C4319828 (UMLS CUI [3,4])
Malignant Neoplasm Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission | Exception Disease Free of Duration
Item
prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0677874 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
C0449238 (UMLS CUI [7,4])
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