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ID

12121

Descrição

Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women; ODM derived from: https://clinicaltrials.gov/show/NCT02400567

Link

https://clinicaltrials.gov/show/NCT02400567

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Versões (1)
  1. 25/09/15 25/09/15 - Julian Varghese
Transferido a

25 settembre 2015

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Licença

Creative Commons BY 4.0
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    Eligibility Neoadjuvant Operable Breast Cancer NCT02400567

    Inglês

    Eligibility Neoadjuvant Operable Breast Cancer NCT02400567

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. aged 18 years, post-menopausal women
    Descrição

    Age | Postmenopausal state

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0232970
    2. newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - note: multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same characteristics: er allred 4, her2- (pam50 will be performed in the largest lesion)
    Descrição

    Breast cancer invasive NOS; Unilateral; Breast-Conserving Surgery; Eligibility Determination

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0853879
    UMLS CUI [1,2]
    C0205092
    UMLS CUI [1,3]
    C0917927
    UMLS CUI [1,4]
    C0013893
    3. stage ii-iiia
    Descrição

    stage ii-iiia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2216702
    4. assessment of nodal status available (ultrasound guided fna or biopsy if necessary)
    Descrição

    ultrasound; assessment; available; biopsy; status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0449927
    5. non metastatic, m0
    Descrição

    metastatic; non

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0445034
    6. er-positive by ihc (allred score≥4)
    Descrição

    allred score; positive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2919519
    7. her2-negative by ihc (score 0 or 1+) and/or fish/cish
    Descrição

    negative; score; cish

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    CL412283
    UMLS CUI [2]
    C0449820
    UMLS CUI [3]
    C0299250
    8. either luminal a and proven nodal involvement (cytology or histology), or luminal b through pam50 ror (prosigna™) centralized evaluation
    Descrição

    luminal type; TNM pathologic staging - nodal involvement - N

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3642345
    UMLS CUI [2]
    C3642346
    UMLS CUI [3]
    C3258251
    9. ecog 0-1
    Descrição

    ecog

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    10. no prior systemic therapy for the present tumor
    Descrição

    prior systemic therapy; present; tumor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1515119
    11. adequate renal, hepatic, and hematopoietic functions as defined by the following criteria: absolute neutrophil count (anc) ≥1,500/mm3 or ≥1.5 x 109/l
    Descrição

    absolute neutrophil count (anc) >=1,500/mm^3; absolute neutrophil count (anc) >=1500/mm3

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0200633
    platelets ≥100,000/mm3 or ≥100 x 109/l
    Descrição

    platelets

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1287267
    hemoglobin ≥9 g/dl
    Descrição

    hemoglobin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019046
    serum aspartate transaminase (ast) and serum alanine aminotransferase transaminase (alt) ≤2.5 x upper limit of normal (uln)
    Descrição

    sgot sgpt got gpt

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0242192
    UMLS CUI [2]
    C0376147
    alkaline phosphatase ≤2.5 x uln
    Descrição

    alkaline phosphatase

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201850
    total serum bilirubin ≤1 x uln
    Descrição

    bilirubin; serum; uln

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    serum creatinine ≤1.5 x uln or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution
    Descrição

    estimated creatinine clearance; serum creatinine; institution; method; uln

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0373595
    12 adequate cardiac functions, including: lead electrocardiogram (ecg) with normal tracing or non clinically significant changes that do not require medical intervention.
    Descrição

    clinically significant; electrocardiogram; normal; ecg; non

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    qtc interval ≤480 msec
    Descrição

    qtc interval

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0489625
    no history of torsades de pointes or other symptomatic qtc abnormality.
    Descrição

    symptomatic; other

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0040479
    UMLS CUI [2,1]
    C0489625
    UMLS CUI [2,2]
    C0205161
    13. willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
    Descrição

    compliance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    14. signed informed consent and health insurance coverage
    Descrição

    signed informed consent; health insurance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0021682
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. non operable, bilateral, t4 or metastatic breast cancer
    Descrição

    metastatic; bilateral; breast; cancer; non

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006142
    UMLS CUI [1,2]
    C0238767
    UMLS CUI [2,1]
    C0006142
    UMLS CUI [2,2]
    C0205187
    UMLS CUI [3]
    C0278488
    UMLS CUI [4]
    C2216713
    2. limited t2 breast cancer immediately accessible to conservative surgery
    Descrição

    surgery; breast; cancer

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038894
    UMLS CUI [2]
    C0006141
    UMLS CUI [3]
    C0006826
    UMLS CUI [4,1]
    C0917927
    UMLS CUI [4,2]
    C0013893
    3. previous homolateral breast cancer (including in situ carcinoma), and/or contralateral breast cancer except if treated by surgery +/- radiation therapy alone without any systemic treatment
    Descrição

    contralateral breast cancer; radiation therapy; treated by; treatment; systemic; surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006142
    UMLS CUI [2]
    C1515119
    UMLS CUI [3]
    C1522449
    4. previous hormone replacement therapy (hrt) stopped less than 2 weeks before beginning of treatment
    Descrição

    hormone replacement therapy; treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0282402
    5. previous use of serms such as raloxifene
    Descrição

    raloxifene

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0244404
    6. any surgery (not including minor procedures such as lymph node biopsy, primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
    Descrição

    major surgery | post operative state

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    UMLS CUI [2]
    C0241311
    7. diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
    Descrição

    diagnosis; malignancy; cervical; squamous; skin; last

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0007137
    UMLS CUI [2]
    C0006826
    UMLS CUI [3]
    C0007117
    UMLS CUI [4]
    C0851140
    8. history of any previous anti-cancer chemotherapy and any previous treatment using ai
    Descrição

    cancer chemotherapy; treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0593802
    9. concurrent administration of herbal preparations as complementary medicine.
    Descrição

    herbal preparations as complementary medicine.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0025125
    10. any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs, such as the inability to take oral medication in tablet form and malabsorption syndrome
    Descrição

    inability to take oral medications; clinically significant; gastrointestinal; malabsorption; abnormalities; syndrome; tablet; drugs; form; study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3714657
    11. patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    Descrição

    sociological psychological factors

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1658764
    UMLS CUI [2]
    C0021430
    UMLS CUI [3]
    C3850138
    UMLS CUI [4]
    C1321605
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    Eligibility Neoadjuvant Operable Breast Cancer NCT02400567

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Postmenopausal state
    Item
    1. aged 18 years, post-menopausal women
    boolean
    C0001779 (UMLS CUI [1])
    C0232970 (UMLS CUI [2])
    Breast cancer invasive NOS; Unilateral; Breast-Conserving Surgery; Eligibility Determination
    Item
    2. newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - note: multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same characteristics: er allred 4, her2- (pam50 will be performed in the largest lesion)
    boolean
    C0853879 (UMLS CUI [1,1])
    C0205092 (UMLS CUI [1,2])
    C0917927 (UMLS CUI [1,3])
    C0013893 (UMLS CUI [1,4])
    stage ii-iiia
    Item
    3. stage ii-iiia
    boolean
    C2216702 (UMLS CUI [1])
    ultrasound; assessment; available; biopsy; status
    Item
    4. assessment of nodal status available (ultrasound guided fna or biopsy if necessary)
    boolean
    C0449927 (UMLS CUI [1])
    metastatic; non
    Item
    5. non metastatic, m0
    boolean
    C0445034 (UMLS CUI [1])
    allred score; positive
    Item
    6. er-positive by ihc (allred score≥4)
    boolean
    C2919519 (UMLS CUI [1])
    negative; score; cish
    Item
    7. her2-negative by ihc (score 0 or 1+) and/or fish/cish
    boolean
    CL412283 (UMLS CUI [1])
    C0449820 (UMLS CUI [2])
    C0299250 (UMLS CUI [3])
    luminal type; TNM pathologic staging - nodal involvement - N
    Item
    8. either luminal a and proven nodal involvement (cytology or histology), or luminal b through pam50 ror (prosigna™) centralized evaluation
    boolean
    C3642345 (UMLS CUI [1])
    C3642346 (UMLS CUI [2])
    C3258251 (UMLS CUI [3])
    ecog
    Item
    9. ecog 0-1
    boolean
    C1520224 (UMLS CUI [1])
    prior systemic therapy; present; tumor
    Item
    10. no prior systemic therapy for the present tumor
    boolean
    C1515119 (UMLS CUI [1])
    absolute neutrophil count (anc) >=1,500/mm^3; absolute neutrophil count (anc) >=1500/mm3
    Item
    11. adequate renal, hepatic, and hematopoietic functions as defined by the following criteria: absolute neutrophil count (anc) ≥1,500/mm3 or ≥1.5 x 109/l
    boolean
    C0200633 (UMLS CUI [1])
    platelets
    Item
    platelets ≥100,000/mm3 or ≥100 x 109/l
    boolean
    C1287267 (UMLS CUI [1])
    hemoglobin
    Item
    hemoglobin ≥9 g/dl
    boolean
    C0019046 (UMLS CUI [1])
    sgot sgpt got gpt
    Item
    serum aspartate transaminase (ast) and serum alanine aminotransferase transaminase (alt) ≤2.5 x upper limit of normal (uln)
    boolean
    C0242192 (UMLS CUI [1])
    C0376147 (UMLS CUI [2])
    alkaline phosphatase
    Item
    alkaline phosphatase ≤2.5 x uln
    boolean
    C0201850 (UMLS CUI [1])
    bilirubin; serum; uln
    Item
    total serum bilirubin ≤1 x uln
    boolean
    C1278039 (UMLS CUI [1])
    estimated creatinine clearance; serum creatinine; institution; method; uln
    Item
    serum creatinine ≤1.5 x uln or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution
    boolean
    C0201976 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    clinically significant; electrocardiogram; normal; ecg; non
    Item
    12 adequate cardiac functions, including: lead electrocardiogram (ecg) with normal tracing or non clinically significant changes that do not require medical intervention.
    boolean
    C0522054 (UMLS CUI [1])
    qtc interval
    Item
    qtc interval ≤480 msec
    boolean
    C0489625 (UMLS CUI [1])
    symptomatic; other
    Item
    no history of torsades de pointes or other symptomatic qtc abnormality.
    boolean
    C0040479 (UMLS CUI [1])
    C0489625 (UMLS CUI [2,1])
    C0205161 (UMLS CUI [2,2])
    compliance
    Item
    13. willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
    boolean
    C1321605 (UMLS CUI [1])
    signed informed consent; health insurance
    Item
    14. signed informed consent and health insurance coverage
    boolean
    C0021430 (UMLS CUI [1])
    C0021682 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    metastatic; bilateral; breast; cancer; non
    Item
    1. non operable, bilateral, t4 or metastatic breast cancer
    boolean
    C0006142 (UMLS CUI [1,1])
    C0238767 (UMLS CUI [1,2])
    C0006142 (UMLS CUI [2,1])
    C0205187 (UMLS CUI [2,2])
    C0278488 (UMLS CUI [3])
    C2216713 (UMLS CUI [4])
    surgery; breast; cancer
    Item
    2. limited t2 breast cancer immediately accessible to conservative surgery
    boolean
    C0038894 (UMLS CUI [1])
    C0006141 (UMLS CUI [2])
    C0006826 (UMLS CUI [3])
    C0917927 (UMLS CUI [4,1])
    C0013893 (UMLS CUI [4,2])
    contralateral breast cancer; radiation therapy; treated by; treatment; systemic; surgery
    Item
    3. previous homolateral breast cancer (including in situ carcinoma), and/or contralateral breast cancer except if treated by surgery +/- radiation therapy alone without any systemic treatment
    boolean
    C0006142 (UMLS CUI [1])
    C1515119 (UMLS CUI [2])
    C1522449 (UMLS CUI [3])
    hormone replacement therapy; treatment
    Item
    4. previous hormone replacement therapy (hrt) stopped less than 2 weeks before beginning of treatment
    boolean
    C0282402 (UMLS CUI [1])
    raloxifene
    Item
    5. previous use of serms such as raloxifene
    boolean
    C0244404 (UMLS CUI [1])
    major surgery | post operative state
    Item
    6. any surgery (not including minor procedures such as lymph node biopsy, primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
    boolean
    C0679637 (UMLS CUI [1])
    C0241311 (UMLS CUI [2])
    diagnosis; malignancy; cervical; squamous; skin; last
    Item
    7. diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
    boolean
    C0007137 (UMLS CUI [1])
    C0006826 (UMLS CUI [2])
    C0007117 (UMLS CUI [3])
    C0851140 (UMLS CUI [4])
    cancer chemotherapy; treatment
    Item
    8. history of any previous anti-cancer chemotherapy and any previous treatment using ai
    boolean
    C0392920 (UMLS CUI [1])
    C0593802 (UMLS CUI [2])
    herbal preparations as complementary medicine.
    Item
    9. concurrent administration of herbal preparations as complementary medicine.
    boolean
    C0025125 (UMLS CUI [1])
    inability to take oral medications; clinically significant; gastrointestinal; malabsorption; abnormalities; syndrome; tablet; drugs; form; study
    Item
    10. any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs, such as the inability to take oral medication in tablet form and malabsorption syndrome
    boolean
    C3714657 (UMLS CUI [1])
    sociological psychological factors
    Item
    11. patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    boolean
    C1658764 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    C3850138 (UMLS CUI [3])
    C1321605 (UMLS CUI [4])
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