araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

Summary: Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Detailed description: Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed Lung adenocarcinoma
  -  Wld-type EGFR
  -  Stage IIIB/IV
  -  Failure to prior chemotherapy
  -  Life expectancy of more than 3 months
  -  Tissue sample desired for genomic study
  -  Age ≥ 18 years
  -  Performance status (WHO) < 3
  -  Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
  -  Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  -  Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
  -  Informed consent
  Exclusion Criteria:
  -  Have previously received pemetrexed or TKIs
  -  Other concurrent uncontrolled illness

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients

Summary: This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.


Eligibility: Inclusion Criteria:
  -  Diagnosis of advanced/metastatic scirrhous gastric carcinoma
  -  Evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion
  -  Patients previously treated with one or two systemic lines
  -  Documented radiological confirmation of disease progression
  -  ECOG performance status of 0 to 2
  -  Male and female patients aged 20 years or greater
  -  Adequate liver, renal, and hematologic function
  Exclusion Criteria:
  -  Patients who received prior treatment with an FGFR inhibitor
  -  Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
  -  Patients with another primary malignancy within 3 years prior to starting study treatment
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer

Summary: The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.

Detailed description: A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Metastatic, Gastric or Gastro-oesophageal Junction, Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status (SAGE)

Eligibility: Inclusion Criteria:
  -  Male or female aged 18 years or older (20 years or older in Japan)
  -  Patients must have radiologically confirmed progression following 1st line fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database)
  -  Suitable for paclitaxel therapy.
  -  At least one lesion, not previously irradiated and not chosen for a mandatory fresh tumour biopsy during the study screening period, that can be accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeat assessment.
  -  Ineligible for trastuzumab treatment by local assessment. This should include IHC analysis to determine HER2 status with further testing by FISH/CISH when considered part of local practice. Eligible patients are defined as; HER2 IHC 0, HER2 IHC +1 and +2
  Exclusion Criteria:
  -  Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted).
  -  Any prior taxane therapy (at any time from diagnosis of gastric cancer)
  -  Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib)
  -  Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1 )
  -  Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous anti-cancer therapy

Relevance to patient case: definitely relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Gastric Cancer Screening and Alarm Symptoms in Early Gastric Cancer

Summary: Most of the early gastric cancer are asymptomatic. Symptoms of advanced gastric cancer are weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal bleeding. Gastric cancer found according to warning symptoms such as gastrointestinal bleeding, weight loss usually can not be cured. Therefore, early gastric cancer can not be detected and impossible to treatment if endoscopy is performed according to the warning signs. National gastric cancer screening is conducted in men and women of more than 40 years old. The purpose of screening for gastric cancer is discovering a case of possible cure, so increasing the survival rate. The purpose of this study is review of the feasibility of screening for gastric cancer.


Eligibility: Inclusion Criteria:
  -  gastric cancer patients in St.mary`s hospital
  Exclusion Criteria:
  -  gastric lymphoma, gastric GIST patients in St.mary`s hospital

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Summary: Helicobacter pylori infection is associated with gastric cancer in epidemiological studies. However, it is still unknown whether H. pylori eradication is useful and required to prevent gastric cancer.
  Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients.
  In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.


Eligibility: Inclusion Criteria:
  -  Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
  -  Informed consent should be signed
  Exclusion Criteria:
  -  Gastric cancer history
  -  Other malignancy within the past 5 years
  -  Hereditary cancer family member (HNPCC, FAP)
  -  Peptic ulcer history
  -  Peptic ulcer, esophageal cancer, gastric cancer case found at EGD
  -  H. pylori eradication treatment history
  -  Previous serious side effect to antibiotics
  -  Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
  -  Pregnant or nursing women
  -  Psychiatric disorder that would preclude compliance, alcoholics
  -  Refuse informed consent

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Prospective Cohort Study for Analyzing the Effect of Gastric Cancer Surgery to the Metabolic Syndrome and Insulin Resistance

Summary: Gastric cancer is still one of the most common malignance in Korea. Because of the popularity of regular check ups, early detection of gastric cancer has increased, consequently, the survival of the patients also has increased. In this reason, the interest of outcomes after gastrectomy for gastric cancer move survival only to quality of life of these patients.
  Although the definition of metabolic syndrome is various, but it is normally accepted as a state that insulin resistance or glucose intolerance combined with hypertension or hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the treatment is modification of life style, weight loss and medication. However, in most of the patients metabolic syndrome is considered not curable disease. Recent studies have shown that some bariatric surgery offers not only control the overweight but also metabolic syndrome. The exact mechanism is still unknown but decreased gastric volume and intestinal bypass itself seemed to play an important role to improve metabolic syndrome over just decreased weight.
  For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy, esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead decreased gastric volume and/or intestinal bypass, which means this operation could lead similar effect of bariatric surgery. Already, there have been several retrospective reports that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no prospective study about this subject yet in Korea.
  The purpose of this study is that evaluating the degree of improvement of metabolic syndrome after gastrectomy for gastric cancer, and analyze the differences between the type of operation.


Eligibility: Inclusion Criteria:
  1. gastric cancer,
  2. in plan for gastrectomy for gastric cancer
  3. ages between 20 to 85 years old
  4. assign in consent
  Exclusion Criteria:
  1. vulnerable subject (pregnant, be devoid of mental capacity, soldiers, or medical students)
  2. had low performance scale due to severe cardiovascular disease.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

Summary: Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.


Eligibility: Inclusion Criteria:
  -  NSCLC confirmed by histopathology or cytology;
  -  Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
  -  Has active mutation of EGFR in exon 19 or 21;
  -  Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  -  expectancy life >= 12 weeks;
  Exclusion Criteria:
  -  Had be treated by HER-targeting agents;
  -  Had systemic anit-NSCLC treatments;
  -  Had local radiotherapy for NSCLC;
  -  Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
  -  Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
  -  Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
  -  Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
  -  Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).

Summary: The EGFR is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments.
  New treatment strategies targeting EGFR have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ. Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)
  Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid in the selection of patients for individualized therapy with EGFR kinase inhibitors.
  Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with EGFR inhibitors.
  The purposes of the study are:
  1. To adjust an optimal treatment for patients with tumors that have high expression of EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during pretreatment work-up; as well as to follow up after treatment response.
  2. To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.


Eligibility: Inclusion Criteria:
  -  patients with NSC type of lung cancer with high expression of EGFR who are candidates for erlotinib as second / third line of treatment;
  -  patients with advanced pancreatic tumor who are candidates for complex gemcitabine and erlotinib treatment.
  Exclusion Criteria:
  -  lack of histological diagnosis;
  -  not a candidate for erlotinib;
  -  pregnancy.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer

Summary: Breast cancer is a heterogeneous disease and can be classified into several distinctive subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER), progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2) overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its aggressive clinical behavior and insensitivity toward available targeted treatment strategies such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early relapse with metastatic disease is common and the prognosis is poor. Development Of novel treatment strategies is,therefore,needed and the study of other potential targets in TNBC,like tyrosine kinase receptors,is a topic of interest.
  Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR mutation was rare in TNBC.
  By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one or more limitations including:1) the study population had received heavily pretreatment; 2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR was not clear in the enrolled patients.
  Here, the investigators launch a prospective clinical trial, and about 50 patients with triple-negative,EGFR positive metastatic breast cancer that have received at least second line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in the metastatic TNBC.


Eligibility: Inclusion Criteria:
  -  ≥18 years of age
  -  ≥1 measurable or assessable lesion
  -  Eastern Cooperative Oncology Group(ECOG)performance status of 0-2
  -  adequate renal,hepatic and hematological function
  -  a life expectancy of >12 weeks
  -  histologically proven EGFR positive metastatic TNBC
  Exclusion Criteria:
  -  brain metastasis

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Detecting EGFR T790M Mutations From Circulating Tumor Cells

Summary: The purpose of this research study is to determine if the EGFR mutation can be detected in CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of patients with cancer. This is an experimental device. Using this device, the investigators will test participants' blood to try and find CTCs with the EGFR mutation and compare them with the results from the biopsy your doctor has recommended. The long-term goal of this research is to develop a way to test for the EGFR mutation that is less invasive than a tumor biopsy.

Detailed description: In order to participate in this study you need to have a diagnosis of NSCLC that has spread or is unable to be surgically removed. In addition, your cancer must have an EGFR mutation and you must have a scheduled (or recently performed) biopsy to check on the presence of any other mutations related to targeted drug resistance.
  After you sign consent to participate in this study we will draw a blood sample (three tubes of blood). This is about 6 teaspoons of blood.
  The number of CTCs in your blood will not be reported to you since it is not known if this number has any meaning or if it impacts your medical care in any way. These results will not become part of your medical record. They will be kept in a separate, secure location.
  We will collect information from your medical records and store it in a research record that we create about you. The study team will use this information to compare details about your medical history with the results of the experiments done on your blood.
  Genetic material (DNA) will be removed from the CTCs found in your blood. This genetic material will be stored at the Massachusetts General Hospital and studied along with samples from other participants on this research study. Your samples will not be labeled with your name or any information that identifies you. Your samples will have a study-specific code number on them. The code linking your name to the sample will be kept in a secure location, available only to the investigators of the study and select study team members.
  After the blood draw we will follow your status every 6 months by reviewing your medical records.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed NSCLC that is metastatic or unresectable
  -  Have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Study of ABT-414 in Subjects With Solid Tumors

Summary: A study of ABT-414 in subjects with solid tumors.


Eligibility: Inclusion Criteria:
  1. Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
  2. Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  3. Subjects have available tumor tissue
  4. Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3; Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine </= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= 5.0 x the upper limit of normal.
  5. Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
  6. Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort
  Exclusion Criteria:
  1. The subject has uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (Phase 1 only).
  2. The subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of ABT-414.
  3. The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
  4. The subject had had major surgery within 28 days prior to the first dose of ABT-414.
  5. The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
  6. Phase 2 portion only: The subject has previous or concurrent cancer that is distinct in primary site or histology from NSCLC, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.

Relevance to patient case: possibly relevant