Breast Carcinoma unresectable Evidence | Breast cancer recurrent Locally Evidence | Carcinoma breast stage IV Evidence | Lesion Amenable Operative Surgical Procedures | Lesion Amenable Therapeutic radiology procedure Curative intent
Item
histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. lesions should not be amenable to surgery or radiation of curative intent.
boolean
C0678222 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,3])
C0278493 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C0278488 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C3900053 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
Neoplasm Metastasis | Recurrent disease local regional
Item
presence of metastatic or local-regional recurrent disease, according to the american joint committee on cancer
boolean
C0027627 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0814836 (UMLS CUI [2,2])
Measurable Disease Linear | Lesion Margin Measurable | X-Ray Computed Tomography | Plain chest X-ray | examination; clinical
Item
uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (ct), chest x-ray or clinical examination, according to recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0205284 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C0040405 (UMLS CUI [3])
C0039985 (UMLS CUI [4])
C1456356 (UMLS CUI [5])
Breast Carcinoma unresectable | Breast cancer recurrent Locally | Carcinoma breast stage IV | Anthracycline Antibiotics | Taxanes, antineoplastic | Paclitaxel | docetaxel | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | First line treatment Neoplasm Metastasis | Disease Progression | Chemotherapy Related Toxic effect | Patients Recovered | Alopecia
Item
patients with unresectable, locally recurrent or metastatic breast cancer who, were pre-treated with anthracyclines with/without taxanes (paclitaxel, docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study. prior chemotherapy has to be terminated 4 weeks prior. study randomization and disease progression under this therapy has to be documented, also patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
boolean
C0678222 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0278488 (UMLS CUI [3])
C0003234 (UMLS CUI [4])
C3541958 (UMLS CUI [5])
C0144576 (UMLS CUI [6])
C0246415 (UMLS CUI [7])
C0600558 (UMLS CUI [8,1])
C3665472 (UMLS CUI [8,2])
C0085533 (UMLS CUI [9])
C1708063 (UMLS CUI [10,1])
C0027627 (UMLS CUI [10,2])
C0242656 (UMLS CUI [11])
C3665472 (UMLS CUI [12,1])
C0439849 (UMLS CUI [12,2])
C0600688 (UMLS CUI [12,3])
C0030705 (UMLS CUI [13,1])
C0521108 (UMLS CUI [13,2])
C0002170 (UMLS CUI [14])
prior radiation therapy Completed | Prior Therapy Related Toxic effect | Patients Recovered | Alopecia | Therapeutic radiology procedure Lesion | Measurable Disease | Tumor Progression
Item
prior radiotherapy must be completed at least 30 days before study entry. patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
boolean
C0279134 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
C0002170 (UMLS CUI [4])
C1522449 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
C1513041 (UMLS CUI [6])
C0178874 (UMLS CUI [7])
Investigational New Drugs
Item
have received treatment within the last 30 days with an investigational drug for any indication before study entry.
boolean
C0013230 (UMLS CUI [1])
cancer treatment | Cytotoxic Chemotherapy | cancer surgery | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Herceptin
Item
concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including herceptin)
boolean
C0920425 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C0920424 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C0021083 (UMLS CUI [6])
C0338204 (UMLS CUI [7])
Communicable Disease Affecting Therapeutic procedure | Communicable Disease Treated Adequate
Item
active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
boolean
C0009450 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
Comorbidity Serious Affecting patient safety | Comorbidity Serious Affecting Protocol Compliance
Item
serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Second Primary Cancers | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated Adequate
Item
second primary malignancy that is clinically detectable at the time of consideration for study enrollment(except in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin)
boolean
C0751623 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])