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

Clinical trial: Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

Summary: The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).


Eligibility: Inclusion Criteria:
  -  Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1
  -  Normal organ and marrow function
  -  No other malignancies within 5 years, except for non-melanoma skin cancer
  Exclusion Criteria:
  -  Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
  -  Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
  -  Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered > 30 days before study enrollment
  -  Receiving anticoagulation therapy with warfarin (low-dose warfarin < 1 mg/day, heparin and low molecular weight heparins are permitted)
  -  The subject meets any of the following cardiac criteria:
  -  Corrected QT interval (QTc) of > 460 msec
  -  Family history of congenital long QT syndrome or unexplained sudden death
  -  History of sustained ventricular arrhythmias
  -  Has a finding of left bundle branch block
  -  Has an obligate pacemaker
  -  Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node dysfunction
  -  Has uncontrolled hypertension
  -  Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
  -  Has a serum potassium or serum magnesium level that falls outside the normal range
  -  The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
  -  Uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Known HIV

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

Clinical trial: Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

Summary: The goals of this study are:
  -  to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
  -  to assess response to treatment in patients with NSCLC six months after beginning study treatment.


Eligibility: Inclusion Criteria:
  -  18 years or older
  -  Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
  -  ECOG performance status score of 0 or 1
  Exclusion Criteria:
  -  Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
  -  Symptomatic or uncontrolled brain metastases
  -  Evidence of meningeal metastasis
  -  > 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
  -  Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments

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 Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer

Summary: This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer


Eligibility: Inclusion Criteria:
  -  females, 18 or older
  -  recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
  -  paraffin-embedded tissue block must be available
  -  measurable disease
  -  prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)
  -  0, 1 or 2 chemotherapies in the metastatic setting
  -  adequate organ function
  Exclusion Criteria:
  -  Metastatic disease confined to bone only
  -  Symptomatic central nervous system (CNS) metastasis
  -  Concurrent medical condition which may increase the risk of toxicity
  -  Unable to take oral medication

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 Avastin in Combination With Chemotherapy for Treatment of Colorectal Cancer and Non-Small Cell Lung Cancer (ARIES)

Summary: This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in combination with first-line chemotherapy. Second-line metastatic CRC patients are also eligible. Patients who started their Avastin containing therapy <4 months prior to enrollment are eligible.


Eligibility: Inclusion Criteria:
  -  Signed Informed Consent Form
  -  Metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology)
  -  Eligible for Avastin as a component of intended therapy
  -  First-line chemotherapy (or second-line chemotherapy for CRC) plus Avastin initiated ≤ 4 months prior to study enrollment
  Exclusion Criteria:
  -  Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment and follow-up, as specified by the investigator
  -  Enrollment in a blinded, placebo-controlled bevacizumab 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: A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

Summary: The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with Herceptin in patients with advanced breast cancer.

Detailed description: Open label phase 1/2 study of ascending multiple oral doses of HKI-272 in combination with IV Herceptin in subjects with advanced HER2+ breast cancer. Three to six subjects will be enrolled in each dose group. Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 21. When the maximum tolerated dose of HKI-272 plus Herceptin is determined, an additional 30 subjects will be enrolled at that dose level, and followed for progression free survival for approximately 1 year.

Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy
  -  Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)
  -  HER2 positive breast cancer
  -  At least one measurable target lesion
  -  Adequate performance status
  -  Adequate cardiac, kidney, and liver function
  -  Adequate blood counts
  -  Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control
  Exclusion Criteria:
  -  More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
  -  Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1
  -  Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
  -  Extensive visceral disease
  -  Active central nervous system metastases
  -  Pregnant or breast feeding women
  -  Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
  -  Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)
  -  Significant cardiac disease or dysfunction
  -  History of life-threatening hypersensitivity to Herceptin
  -  Inability or unwillingness to swallow HKI-272 capsules
  -  Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin

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

Clinical trial: Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

Summary: As clinical primary endpoints we assessed whether existed differences in:
  1. PSA recurrence rate stratified according to treatment modalities
  2. EGFR and HER2/neu overexpression rate stratified according to treatment modalities
  3. PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.
  As secondary clinical endpoints we assessed whether existed differences in:
  1. prostate cancer-specific mortality according to treatment modalities
  2. prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels.
  For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified for high and low EGFR and HER2/Neu expression levels. The evaluation of efficacy rate of these treatments was documented by comparing the differences of drugs IC50 values among the groups stratified for EGFR and HER2/Neu levels.


Eligibility: Inclusion Criteria:
  -  Patients were eligible if they had histologically confirmed adenocarcinoma of the prostate and the following high-risk features: (1) clinical stage T3a disease with (2) Gleason sum of 7 with a predominant component of 4 (i.e., Gleason 4 + 3 = 7) or (4) Gleason sum of 8, 9 or 10.
  Exclusion Criteria:
  -  Prior hormonal therapy,
  -  Prior radiation,
  -  Prior investigational agents,
  -  Prior malignancy within the last five years or had any other serious medical or psychiatric condition or illness that would not permit the patient to be managed according to the protocol were excluded.

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

Clinical trial: T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

Detailed description: OBJECTIVES:
  -  Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.
  OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.
  Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of solid epithelial tumor, including, but not limited to, the following:
  -  Breast cancer
  -  Ovarian cancer
  -  Lung cancer
  -  Uterine cancer
  -  Prostate cancer
  -  HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
  -  Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)
  PATIENT CHARACTERISTICS:
  -  Absolute neutrophil count > 1,000/mm^3
  -  Absolute lymphocyte count > 400/mm^3
  -  Platelet count > 90,000/mm^3
  -  Hemoglobin > 8 g/dL
  PRIOR CONCURRENT THERAPY:
  -  No other chemotherapy within the past 4 weeks

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

Clinical trial: A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

Summary: The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.


Eligibility: Inclusion Criteria:
  Inclusion criteria for both parts of clinical trial:
  -  Good performance status
  -  Normal ejection fraction
  -  Adequate cardiac, kidney, and liver function
  -  Adequate blood counts
  -  At least one measurable target lesion
  -  Negative pregnancy test for female subjects
  Inclusion Criteria for Part 1 Only:
  - Pathologically confirmed solid tumor not curable with available standard therapy
  Inclusion Criteria for Part 2 Only:
  -  Pathologically confirmed breast cancer
  -  HER2 positive tumor
  -  Prior treatment with Herceptin
  Exclusion Criteria:
  Exclusion criteria for both parts of clinical trial:
  -  Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1
  -  Subjects with bone or skin as the only site of disease
  -  Active central nervous system metastases
  -  Significant cardiac disease or dysfunction
  -  Significant gastrointestinal disorder
  -  Inability or unwillingness to swallow HKI-272 capsules
  -  Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.
  -  Treatment with a taxane within 3 months of treatment day 1
  -  Grade 2 or greater motor or sensory neuropathy
  -  Pregnant or breast feeding women
  -  Known hypersensitivity to paclitaxel or Cremophor EL
  -  Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
  -  Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
  Exclusion Criteria for Part 2 Only:
  - More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease

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

Clinical trial: Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy

Summary: RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment.
  PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.

Detailed description: OBJECTIVES:
  -  Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy.
  OUTLINE: This is a prospective study.
  Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer
  -  Any disease stage allowed
  -  Undergoing targeted treatment
  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: GW572016 In Patients With Advanced Or Metastatic Breast Cancer

Summary: This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.


Eligibility: Inclusion Criteria:
  -  Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
  -  Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
  -  Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
  Exclusion Criteria:
  -  Patients with certain heart problems.

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

Clinical trial: DNA Analysis of Blood and Tissue From Patients With Lung Cancer

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

Detailed description: OBJECTIVES:
  -  Assess the role of genetic polymorphisms in lung-cancer risk in patients with lung cancer.
  -  Assess the role of germline polymorphisms in DNA repair genes, p53 pathway genes, and a matrix metalloproteinase gene (tumor invasion factor) in lung-cancer risk, after adjusting for potential confounders.
  -  Assess the roles of gender and age in the genetic susceptibility of lung cancer.
  -  Assess the role of genetic polymorphisms in modifying the diet-lung cancer risk association (gene-diet and exploratory gene-gender-diet and gene-gene-diet interactions).
  -  Assess the role of polymorphisms on the risk of developing specific histologic subtypes of lung cancer in case-only analyses.
  -  Determine whether continued exposures to mainstream and/or second-hand tobacco smoking is associated with poorer clinical prognosis in patients treated for lung cancer.
  OUTLINE: This is a case-control study.
  Blood samples are collected from patients and controls. Samples are analyzed by polymerase chain reaction for gene polymorphisms. Genes to be studied include GSTP1, GSTM1, GSTT1, ERCC2, XRCC1, EPHX, NAT-2, p53 gene, CYP1A1, NQO1, MnSOD, and GPX1. Tissue samples collected from patients undergoing surgery and blood samples are archived for future studies.
  Patients and controls complete questionnaires about diet, medical history, and occupational/environmental history.
  PROJECTED ACCRUAL: A total of 3,400 patients and 3,400 controls will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patient:
  -  Newly diagnosed lung cancer
  -  Patient at Massachusetts General Hospital (MGH) or Boston Medical Center Cancer Center
  -  Control:
  -  Nonblood-related friend or spouse of the patient
  -  No specific matching characteristics
  -  Friend or spouse of other hospital patients
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified
  EXCLUSIONS:
  Healthy controls with other primary cancers (melanoma, colon, etc.) are excluded Vulnerable populations are excluded

Relevance to patient case: not relevant