Adult | Gender | Age
Item
adult women (≥ 18 years old).
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Invasive carcinoma of breast | Recurrent disease Local | Neoplasm Metastasis
Item
histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
boolean
C0853879 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
Measurable lesion Quantity | Bone lesion Without Measurable Disease
Item
must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
HER2/Neu Positive Laboratory Procedures | Immunohistochemistry Positive Staining | In Situ Hybridization Positive
Item
her2+ patients by local laboratory testing (ihc 3+ staining or in situ hybridization positive).
boolean
C2348909 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0021044 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0487602 (UMLS CUI [2,3])
C0162788 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Trastuzumab To be stopped | Taxane To be stopped | Neoadjuvant Chemotherapy To be stopped | Adjuvant Chemotherapy To be stopped
Item
prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.
boolean
C0728747 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C1272691 (UMLS CUI [3,3])
C0085533 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
Breast Carcinoma Therapeutic procedure To be stopped | Prior adjuvant endocrine therapy To be stopped | Neoplasm Metastasis Hormone Therapy To be stopped | Diphosphonates allowed
Item
prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
boolean
C0678222 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
C0281266 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
C1272691 (UMLS CUI [3,3])
C0012544 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Pregnancy test negative
Item
documentation of negative pregnancy test.
boolean
C0427780 (UMLS CUI [1])
mTOR Inhibitors Cancer treatment
Item
prior mtor inhibitors for the treatment of cancer.
boolean
C1515672 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Cancer treatment Locally advanced breast cancer | Cancer treatment Secondary malignant neoplasm of female breast | Exception Hormone Therapy
Item
other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.
boolean
C0920425 (UMLS CUI [1,1])
C3495949 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
Non-Measurable Lesion only | Pleural effusion | Ascites | Exception Secondary malignant neoplasm of bone
Item
patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
boolean
C1334988 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0153690 (UMLS CUI [4,2])
Therapeutic radiology procedure Bone Marrow Percentage
Item
radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
CNS metastases
Item
history of central nervous system metastasis.
boolean
C0686377 (UMLS CUI [1])
Abnormal digestive tract function | Gastrointestinal Diseases | Ulceration Upper gastrointestinal tract
Item
impairment of gastrointestinal (gi) function or gi disease or active ulceration of the upper gastrointestinal tract.
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C3887532 (UMLS CUI [3,1])
C1268997 (UMLS CUI [3,2])
Peripheral Neuropathy Serious
Item
serious peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Heart Diseases | Cardiac dysfunction
Item
cardiac disease or dysfunction.
boolean
C0018799 (UMLS CUI [1])
C3277906 (UMLS CUI [2])
Uncontrolled hypertension
Item
uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
HIV Infection
Item
hiv.
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Clinical Trial Eligibility Criteria Study Protocol
Item
pregnant, other protocol-defined inclusion/exclusion criteria may apply
boolean
C0032961 (UMLS CUI [1])
C1516637 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])