Solid tumour incurable | HKI 272 Treatment option | Vinorelbine Treatment option | Breast Carcinoma HER2/Neu Positive TNM Breast tumor staging | Gender
Item
confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which hki-272 plus vinorelbine is a reasonable treatment option (part 1 only) or confirmed pathologic diagnosis of erbb-2-positive breast cancer (current stage iv) in female subjects for which vinorelbine plus hki-272 is a reasonable treatment option (part 2 only).
boolean
C0280100 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C1454298 (UMLS CUI [2,1])
C0683525 (UMLS CUI [2,2])
C0078257 (UMLS CUI [3,1])
C0683525 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C2348909 (UMLS CUI [4,2])
C0474926 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5])
Chemotherapy Regimen Quantity Neoplasm Metastasis | trastuzumab | Adjuvant therapy | Recurrent disease
Item
at least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
Measurable lesion Quantity
Item
at least 1 measurable lesion as defined by response evaluation criteria in solid tumors (recist).
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Antineoplastic Therapy Quantity Neoplasm Metastasis | Exception Hormone Therapy | Adjuvant therapy | Recurrent disease | Chemotherapy Neoplasm Metastasis
Item
more than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only).
boolean
C2346834 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
Vinorelbine Neoplasm Metastasis | Pharmaceutical Preparations Targeting erbB-2 | Exception trastuzumab | Secondary malignant neoplasm of female breast erbB-2 Overexpression | lapatinib
Item
prior treatment with vinorelbine for metastatic setting, or prior treatment with any erbb-2 targeted agents except trastuzumab (part 2 only). up to 20 subjects with erbb-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.
boolean
C0078257 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0069515 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0728747 (UMLS CUI [3,2])
C0346993 (UMLS CUI [4,1])
C0069515 (UMLS CUI [4,2])
C1514559 (UMLS CUI [4,3])
C1506770 (UMLS CUI [5])
Anthracyclines | Doxorubicin Cumulative Dose | Epirubicin Dose | Anthracycline Derivatives Dose Equivalent
Item
prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).
boolean
C0282564 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0282564 (UMLS CUI [4,1])
C0243072 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205163 (UMLS CUI [4,4])