Imaging study | Therapy Advanced breast cancer HER2 Positive | trastuzumab | Chemotherapy | Hormone Therapy
Item
1. all patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced her2 positive breast cancer (this includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).
boolean
C1881134 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3495917 (UMLS CUI [2,2])
C2348909 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
Invasive carcinoma of breast HER2 Positive | HER2 gene amplification Fluorescent in Situ Hybridization | Recurrent disease Locally | Neoplasm Metastasis
Item
2. histologically confirmed her 2 positive (defined as fish amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease.
boolean
C0853879 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4])
Metastatic Lesion Positive FDG-PET
Item
3. patients with fdg-pet positive metastatic lesions.
boolean
C1513183 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Controlled | Absence Metastatic cancer site Solitary
Item
4. brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.
boolean
C0220650 (UMLS CUI [1,1])
C2911690 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0280457 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Metastatic site Biopsy Planned | HER2 Status Control
Item
5. patient planned to have metastatic site biopsy for her2 status control.
boolean
C0280457 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1512413 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
Age
Item
6. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status (ps) 0 to 1
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Pregnancy Test | Childbearing Potential Contraceptive methods | Exception Hormonal contraception
Item
8. for women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2985296 (UMLS CUI [3,2])
Agreement imaging study | Lesion Quantity Biopsy
Item
9. agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.
boolean
C0680240 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
Informed Consent
Item
10. signed written informed consent (approved by the ethics committee) obtained prior to any study procedure
boolean
C0021430 (UMLS CUI [1])
Systemic disease Severe Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease
Item
1. current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection | Hepatitis B | Hepatitis C
Item
3. current known infection with hiv, hbv, or hcv
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Severe allergy Trastuzumab
Item
4. known severe hypersensitivity to trastuzumab
boolean
C2945656 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
5. assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Secondary malignant neoplasm of bone only
Item
6. patients with bone only metastases are not eligible
boolean
C0153690 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
7. psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
lapatinib | Status pre- Immunotherapy PET-CT
Item
8. patients who received lapatinib within the 7 days prior to her immunopet/ct.
boolean
C1506770 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C1699633 (UMLS CUI [2,3])