araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Lung Screening Study

Summary: RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung cancer in patients who are at high risk for the disease.
  PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.

Detailed description: OBJECTIVES: I. Compare the efficacy of screening spiral CT scan and screening chest x-ray in detecting lung cancer in current or former smokers at high risk for lung cancer.
  OUTLINE: This is a randomized, multicenter study of lung cancer screening. Patients are randomized to one of two screening arms. Arm I: Patients undergo one spiral CT scan. Arm II: Patients undergo one chest x-ray. Patients and their primary care physicians are notified of test results within 3 weeks of the exam.
  PROJECTED ACCRUAL: A total of 3,000 participants (1,500 per screening arm) will be accrued for this study at six screening centers (500 per center) by October 31, 2000.

Eligibility: DISEASE CHARACTERISTICS: See General Eligibility Criteria
  PATIENT CHARACTERISTICS: Age: 55 to 74 Patients with a cigarette smoking history of at least 30 pack-years Current smoker OR Smoker who has quit smoking within the past 10 years No known prior history of lung cancer
  PRIOR CONCURRENT THERAPY: No concurrent therapy for any cancer except nonmelanomatous skin cancer No prior removal of any portion of the lungs No concurrent participation in other cancer screening trial, including PLCO No concurrent participation in a primary cancer prevention trial other than a smoking cessation trial

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.
  PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
  -  Determine the efficacy of this treatment, in terms of local control, in these patients.
  -  Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.
  OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.
  Patients are followed at 1, 3, 6, and 12 months.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Diagnosis of a primary or secondary intrathoracic malignancy
  -  Any cell type or origin
  -  Involving the intrapulmonary, mediastinal, or pleural/chest wall
  -  Inoperable primary or metastatic cancer to the lung
  -  Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
  -  Single or multiple lesions that are non-contiguous with vital structures or organs such as:
  -  Trachea
  -  Heart
  -  Aorta
  -  Great vessels
  -  Esophagus
  -  Less than 5 cm in largest dimension
  -  Accessible via percutaneous transthoracic route
  -  Hepatic:
  -  Coagulation profile normal

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Detailed description: This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Eligibility: Patients must have:
  -  Pathologic (histologic or cytologic) confirmation of NSCLC
  -  Stage IIIB with malignant pleural effusion or Stage IV disease
  -  At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
  -  ECOG performance status 0 or 1
  -  Adequate organ system function
  -  Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).
  Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
  Patients must not have had:
  -  Brain metastasis
  -  Prior chemotherapy for NSCLC
  -  Prior platinum-based chemotherapy for any indication

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Detailed description: This study evaluates the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Eligibility: Patients must have:
  -  Pathologic (histologic or cytologic) confirmation of NSCLC
  -  Stage IIIB with malignant pleural effusion or Stage IV disease
  -  At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
  -  ECOG performance status 0 or 1
  -  Adequate organ system function
  -  Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).
  Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
  Patients must not have had:
  -  Brain metastasis
  -  Prior chemotherapy for NSCLC
  -  Prior platinum-based chemotherapy for any indication

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Summary: The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Signed Informed Consent
  -  Able to swallow an oral medication
  -  Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
  -  Adequate kidney and liver function
  -  Adequate bone marrow function
  -  Tumor tissue available for testing
  -  Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
  -  No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
  Exclusion criteria:
  -  Prior treatment regimens for advanced or metastatic breast cancer.
  -  Pregnant or lactating
  -  Conditions that would effect the absorption of an oral drug
  -  Active infection
  -  Brain metastases
  -  Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
  -  Known hypersensitivity to Taxol or excipients of Taxol
  -  Peripheral neuropathy of Grade 2 or greater is not permitted
  -  Severe Cardiovascular disease or cardiac disease requiring a device.
  -  Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

Summary: The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Histologically confirmed non-small cell lung cancer (NSCLC)
  -  Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
  -  Measurable disease by RECIST
  -  ECOG status of 0-1
  -  Adequate liver and renal function
  -  Adequate bone marrow reserves
  Exclusion Criteria:
  -  Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
  -  Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
  -  History of bone marrow transplantation or stem cell support
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Summary: This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  -  Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
  -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
  -  Adequate renal, hepatic and cardiac function
  Exclusion criteria:
  -  Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
  -  Patients with active brain metastases
  -  Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

Summary: The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.
  A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.
  Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.


Eligibility: Inclusion Criteria:
  -  ≥ 18 years old
  -  ECOG score of 0, 1, or 2
  -  Histologically confirmed diagnosis of non-small cell lung cancer
  Exclusion Criteria:
  Laboratory values demonstrating inadequate function of the following:
  -  Bone marrow
  -  Kidneys
  -  Liver
  and
  -  Peripheral neuropathy Grade 2 or higher
  -  Greater than 2 prior chemotherapy regimens

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study of Oral AEE788 in Adults With Advanced Cancer

Summary: AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed solid tumor
  -  Adequate hematologic, renal and hepatic function
  -  Age ≥ 18 years
  -  Karnofsky performance status score ≥ 70%
  -  Life expectancy ≥ 12 weeks
  Exclusion Criteria:
  -  Active brain metastases
  -  Peripheral neuropathy > grade 2
  -  Diarrhea > grade 1
  -  Gastrointestinal (GI) dysfunction
  -  Compromised cardiac function
  -  Concurrent severe and/or uncontrolled medical conditions

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study Evaluating HKI-272 in Tumors

Summary: The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose for HKI-272. In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.


Eligibility: Inclusion Criteria:
  -  Her2/neu or Her1/EGFR positive cancer
  -  ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
  -  Measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors)
  Exclusion Criteria:
  -  Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m2
  -  Patients with significant cardiac risk factors
  -  Active central nervous system metastasis

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer

Summary: The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

Detailed description: Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.
  Patients will be placed into one of 2 arms.
  -  Arm 1 receives 12 weeks of herceptin and navelbine. Arm 2 receives 4 cycles of taxotere/carboplatin/herceptin.
  -  Arm 2 participants will also receive neulasta (growth factor support) on day 2 of each cycle.
  Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.
  Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.
  Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.

Eligibility: Inclusion Criteria:
  -  Patients with stage II or III breast cancer
  -  HER-2 positive tumors
  -  Older than 18 years of age
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
  -  ANC > 1,500/mm3
  -  Hemoglobin > 9gm/dl
  -  Platelets > 100,000mm3
  -  Creatinine < 2mg/dl
  -  Glucose < 200mg/dl
  -  Bilirubin < 1.5 x ULN
  Exclusion Criteria:
  -  Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
  -  Pregnant or breast-feeding women
  -  Serious illness, or medical or psychiatric condition
  -  Uncontrolled infections
  -  Active or severe cardiovascular or pulmonary disease
  -  Patients with left ventricular ejection fraction < 50%
  -  Peripheral neuropathy of any etiology that exceeds grade 1
  -  Prior history of malignancy
  -  Uncontrolled diabetes

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: SERPIN D1 and Its Role in Lung Cancer Invasion and Metastasis

Summary: To evaluate the correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Detailed description: Lung cancer is the leading cause of cancer death in Taiwan and world wild. Although there were progresses in the diagnosis and treatment of lung cancer, the incidence and mortality rate of lung cancer increased in recent years. In many cases, lung cancer is not diagnosed and treated until cancer cells have already invaded surrounding tissues and metastasized throughout the body. Only 15% of lung cancer patients were operable at presentation and about half of them had long term survival. The remaining almost died of metastatic disease. Detecting lung cancers when they are at their earliest stages, and identify cancers with metastatic potential will have a higher probability of truly curing the disease. Molecules that are expressed uniquely or at high level by tumor cells in comparison to normal tissues and that may be secreted into accessible fluids such as blood, urine, or sputum may be useful as lung cancer biomarkers. By using tools in SAGE Genie of Cancer Genome Anatomy Project (CGAP), we identified a secreted protein, SERPIN D1, as an overexpressed gene in non-small cell lung cancer as compared with normal lung and any other normal tissue. In an established panel of human lung adenocarcinoma cell lines with different invasive activities (CL1–0 cells and its sublines CL1–1, and CL1–5, in ascending order of activity), we detected that the expression of SERPIN D1 was higher in CL1-5 than in CL1-0 and CL1-1. According to our preliminary results, we hypothesize that SERPIN D1 may play a role in lung cancer invasion and metastasis and may serve as a serum biomarker for prognosis stratification. For this study, we are going to evaluate the potential correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Eligibility: Inclusion Criteria:
  -  non-small cell lung cancer patient, pathological proved
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe)

Summary: The purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.


Eligibility: Inclusion Criteria:
  1. Metastatic or locally recurrent breast cancer
  2. 18 years of age or older
  3. Her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization [FISH] +)
  4. One of the following:
  1. currently receiving hormonal therapy or are candidates for such, or
  2. being considered for trastuzumab, or
  3. cancer has progressed on trastuzumab.
  Exclusion Criteria:
  1. Pregnant or lactating women.
  2. Prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for more than five years prior to study entry.
  3. Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. [Note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.]
  4. Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
  5. Hemoglobin < 80 g/L or granulocytes < 1.5 × 10^9/L or lymphocytes < 1.0 × 10^9/L or platelets < 100 × 10^9/L.
  6. Baseline liver enzymes (AST or ALT) greater than 3 times the upper limit of normal or greater than 5 times the upper limit of normal if liver metastases are present and/or bilirubin is greater than 50 mmol.
  7. CD4 cells < 0.5 ×10^9/L
  8. Patients with documented brain metastases.
  9. Patients with any acute illness that would interfere with the collection of CD34+ cells or administration of vaccination cellular therapy (i.e. unstable angina, renal or liver failure, or severe chronic obstructive airway disease).
  10. Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
  11. Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
  12. Patients with a life expectancy of less than 6 months.
  13. Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Juravinski Cancer Center and the Henderson site of the Hamilton Health Sciences.
  14. Failure to give written informed consent.
  15. Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multigated acquisition (MUGA) scan.

Relevance to patient case: not relevant