araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598

Summary: RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.

Detailed description: OBJECTIVES:
  -  Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598.
  -  Correlate mutations with time to progression and survival of these patients.
  OUTLINE: This is a multicenter study.
  Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598.
  PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of non-small cell lung cancer meeting ≥ 1 of the following criteria:
  -  Recurrent disease
  -  Stage IIIB with pleural or pericardial effusion
  -  Stage IV disease
  -  Treated on protocol ECOG-2598
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: definitely relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Identifying Early Lung Cancer Cells in Malignant Pleural Effusion Samples From Patients With Primary Lung Cancer

Summary: RATIONALE: Studying samples of pleural fluid in the laboratory from patients with lung cancer may help doctors identify early lung cancer cells. It may also help the study of lung cancer in the future.
  PURPOSE: This laboratory study is looking at malignant pleural effusion samples from patients with primary lung cancer to see if early lung cancer cells can be identified.

Detailed description: OBJECTIVES:
  -  Isolate and identify lung cancer precursor cells in discarded pleural fluid specimens obtained during routine thoracentesis procedures for the diagnosis and treatment of malignant pleural effusions.
  OUTLINE: Malignant pleural effusion specimens obtained from the Pathology Department at the University Hospitals of Cleveland are analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin. The isolated cells are then stained with fluorescent DNA binding dye, Hoechst 33342, and other markers (i.e., CD133, CD24/CD44) and sorted by flow cytometry into progenitor and nonprogenitor subpopulations. The sorted subpopulations are separated and examined functionally by in vitro and in vivo studies. Sphere culture studies are also performed on the sorted subpopulations. The specimens may also be utilized for transcriptional profiling studies, RNAi studies, and for the establishment of long-term cultures and cell lines. DNA is also isolated and stored from tumor and nonepithelial normal cell compartments for future genetic studies on known and unidentified genetic abnormalities contributing to the development of lung cancer, such as EGFR, ErbB2, K-ras, and p53 mutational status.

Eligibility: DISEASE CHARACTERISTICS:
  -  Cytologically positive malignant pleural effusion secondary to primary small cell or non-small cell lung cancer
  -  Recruited from the Division of Hematology/Oncology, the Multidisciplinary Thoracic Oncology Group of Ireland Cancer Center, or the inpatient or outpatient units of Case Medical Center-University Hospitals
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

Summary: RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.

Detailed description: OBJECTIVES:
  -  To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
  -  To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.
  OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.
  Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.

Eligibility: Inclusion Criteria:
  -All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.
  Exclusion Criteria:
  -  Inability to provide informed consent
  -  Minors
  -  Pregnant women

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Lapatinib Resistance in Patients With Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.
  PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.

Detailed description: OBJECTIVES:
  -  To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
  -  To investigate ErbB2 copy number changes and expression levels.
  -  To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.
  OUTLINE: Previously collected tumor tissue samples* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.
  NOTE: *Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.

Eligibility: DISEASE CHARACTERISTICS:
  -  Pathologically confirmed invasive breast cancer
  -  ErbB2-positive disease
  -  Has received or is currently receiving lapatinib ditosylate
  -  Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)
  -  Must have tumor tissue samples available for research studies
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Not pregnant*
  -  Coagulation profile normal*
  -  Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Concurrent chemotherapy or trastuzumab (Herceptin®) allowed
  -  No concurrent anticoagulants, including warfarin or low-molecular weight heparin*
  -  No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Studying Tumor Tissue Samples and Blood Samples to Learn More About DNA Changes in Patients With Lung Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at tumor tissue samples and blood samples to learn more about DNA changes in patients with lung cancer.

Detailed description: OBJECTIVES:
  -  Examine the mutational status of the EGFR pathway in tumor and blood samples from patients with lung cancer.
  -  Correlate the EGFR pathway mutations in these samples with clinical outcomes of these patients.
  OUTLINE: Archived tumor tissue and blood samples are analyzed via PCR to detect EGFR pathway mutations in DNA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed lung cancer
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  May have received prior EGFR inhibitors

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

Summary: This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.


Eligibility: Inclusion Criteria:
  -  ErbB-2 positive locally recurrent or metastatic breast cancer
  -  Eastern Cooperative Oncology Group (ECOG) 0-2
  -  Measurable disease
  -  Availability of tumor tissue for HER2 status confirmation
  Exclusion Criteria:
  -  Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
  -  Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
  -  Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
  -  history of heart disease
  -  history of gastrointestinal disease

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer

Summary: RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
  PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
  Secondary
  -  Determine the progression-free survival in patients treated with this regimen.
  -  Determine the overall survival in patients treated with this regimen.
  -  Determine the safety and tolerability of this regimen in these patients.
  -  Determine the psycho-neurological effects of this regimen in these patients.
  -  Determine the quality of life of patients treated with this regimen.
  OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.
  -  Group 1: Patients undergo prophylactic brain radiotherapy.
  -  Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.
  After completion of study therapy, patients are followed up periodically.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed non-small cell lung cancer
  -  Stage IIIB or IV disease
  -  Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
  -  At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
  -  Stable disease allowed provided 1 of the following criteria is met:
  -  EGFR mutation (exon 19 or 21)
  -  Having ≥ 2 of the following 3 factors:
  -  Female
  -  Never smoked
  -  Histologically confirmed adenocarcinoma of the lung
  -  No evidence of brain metastases by CT scan or MRI within the past 4 weeks
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  ANC ≥ 1,500/mm^3
  -  Platelet count ≥ 150,000/mm^3
  -  Bilirubin < 1.5 mg/dL
  -  Serum creatinine < 1.5 times upper limit of normal
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Received 1 or 2 prior systemic chemotherapy regimens

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer

Summary: This is a research study in 2 parts assessing the following parameters of the combination of the study drug called bosutinib, and a drug called capecitabine: the safety, how well the subject's body handles the study drug, and preliminary anti-tumor activity as treatment for different types of cancers in part 1, and breast cancer only in part 2.
  In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels of each drug in order to determine the highest tolerated dose of the combination study treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest tolerated dose to see how well the study treatment works to treat breast cancer. In addition, genetic research testing (research analyses involving genes and gene products) will be performed on biological samples from subjects.

Detailed description: The study was prematurely discontinued following Part 1 evaluation, when the sponsor concluded that further translational biomarker analyses were needed to better define the breast tumor biomarkers that predict sensitivity to Src family kinase inhibitors. Thus the Sponsor made a determination to stop the study after Part 1 as communicated to investigators on 02Dec2010 . No subjects were enrolled into Part 2 of this study. The study was not terminated due to safety reasons.

Eligibility: Inclusion Criteria:
  Part 1:
  -  Ages eligible for study: 18 years or older.
  -  Male and female.
  -  Confirmed pathologic diagnosis of advanced breast cancer or pancreatic cancer or colorectal cancer or cholangiocarcinoma or glioblastoma not curable with available therapies, for whom bosutinib plus capecitabine is a reasonable treatment option.
  Part 2:
  -  Ages eligible for study: 18 years or older.
  -  Female.
  -  Confirmed pathologic diagnosis of locally advanced or metastatic breast cancer, or loco-regional recurrent breast cancer that is not amenable to curative treatment with surgery or radiotherapy.
  -  Documented ER+ and/or PgR+/erbB2- or ER-/PgR-/erbB2- tumor based upon recently analyzed biopsy.
  Exclusion Criteria:
  Part 1:
  -  Prior bosutinib, or any other prior Src inhibitor.
  -  Prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease is allowed unless patient stopped therapy for toxicity.
  Part 2:
  -  Prior bosutinib, or any other prior Src inhibitor prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease.
  -  Prior chemotherapy with capecitabine or 5-FU for adjuvant chemotherapy within the past 12 months.
  -  erbB2+ breast cancer.

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Study of Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer. ICORG 07-12

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at blood samples from patients with malignant melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To assess which potential peptide and protein markers produced by human melanoma, lung, breast, pancreatic, and colorectal cell lines may be detectable in serum of patients from these five disease groups.
  Secondary
  -  To conduct further extensive investigation with respect to identification of the protein/peptide involved, determination of specificity for each cancer, and development of more sensitive assays to look for such markers in a wider population of patients, including those undergoing therapy.
  OUTLINE: This is a multicenter study.
  Blood samples are collected before surgical intervention or treatment to assess peptide and protein markers.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following advanced metastatic malignancies:
  -  Malignant melanoma
  -  Lung cancer
  -  Breast cancer
  -  Pancreatic carcinoma
  -  Colorectal cancer
  -  Advanced and/or metastatic disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Specialized Radiation Therapy in Treating Patients With Stage II, Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status

Summary: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
  PURPOSE: This phase I trial is studying the side effects and best dose of specialized radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent non-small cell lung cancer and poor performance status.

Detailed description: OBJECTIVES:
  Primary
  -  To escalate the dose of accelerated hypofractionated image-guided conformal radiotherapy to a potent tumoricidal dose without exceeding the maximum-tolerated dose in patients with recurrent or stage II-IV non-small cell lung cancer and poor performance status.
  Secondary
  -  To evaluate local regional tumor control and overall survival of patients treated with this regimen.
  OUTLINE: Patients undergo accelerated hypofractionated image-guided conformal radiotherapy once daily, 5 days a week, for 3 weeks (15 fractions). Treatment continues in the absence of disease progression or unacceptable toxicity.
  After completion of study therapy, patients are followed up periodically for up to 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed non-small cell lung cancer
  -  Stage II-IV and/or recurrent disease
  -  No small cell histology
  -  Measurable or evaluable disease
  -  Tumor not amenable to surgical resection
  -  Tumor not eligible for stereotactic body radiation therapy
  -  No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  PATIENT CHARACTERISTICS:
  -  Zubrod performance status 2-4
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must agree to use effective contraception
  -  Must complete all required pretreatment evaluations
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  More than 1 week since prior chemotherapy or chemoradiation therapy
  -  No concurrent chemotherapy
  -  No other concurrent antineoplastic therapy (including standard-fractionated radiotherapy to the chest, chemotherapy, biological therapy, vaccine therapy, and surgery) 1 week before, during, and for 1 week after completion of study therapy

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Breast Cancer With Over-expression of erbB2-BRAINSTORM

Summary: This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.


Eligibility: Inclusion Criteria:
  1. Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
  2. Brain metastasis diagnosis made between January 2006 - December 2008.
  Exclusion Criteria:
  1. Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
  2. Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)

Relevance to patient case: not relevant