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

Clinical trial: SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)

Summary: To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.


Eligibility: Inclusion Criteria:
  -  Age >=18 years, either sex, any race.
  -  Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease.
  -  BREAST CANCER:
  -  participant must have previously received both a taxane and an anthracycline (unless anthracycline therapy is contraindicated) in the adjuvant and/or metastatic setting,
  -  participant with HER2-positive disease must have progressed after trastuzumab and concomitant or subsequent lapatinib,
  -  participant must have received at least one, but no more than two prior regimens for recurrent or metastatic disease (endocrine and biologic therapies do not count as chemotherapeutic regimens).
  -  NSCLC: at least one, but no more than two prior chemotherapeutic regimens for advanced disease.
  -  Measurable disease by the RECIST.
  -  Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
  -  Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
  -  Ability to swallow tablets.
  Exclusion Criteria:
  -  Known brain metastases. For NSCLC only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization.
  -  History of previous radiation therapy to >25% of total bone marrow.
  -  Known HIV infection.
  -  Known active hepatitis B or hepatitis C.
  -  Previous treatment with SCH 727965 or other cyclin-dependent-kinase inhibitors.
  -  BREAST CANCER:
  -  known dihydropyrimidine dehydrogenase deficiency,
  -  previous treatment with capecitabine.
  -  NSCLC: previous treatment with erlotinib.

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

Clinical trial: Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease

Summary: RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.
  PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.

Detailed description: OBJECTIVES:
  -  Correlate optical coherence tomography images of the airway with airway histology.
  -  Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.
  OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Undergoing pneumonectomy or lobectomy for malignant or benign lung processes
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer

Summary: The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.


Eligibility: Inclusion Criteria:
  -  Non-small cell lung cancer stage IIIB or IV
  -  Not eligible for radical radiotherapy or surgery
  -  WHO performance status 0-2
  Exclusion Criteria:
  -  Pregnancy
  -  Other clinical active cancer disease
  -  ALAT/ALP more than 3 times upper normal limit, bilirubin >1.5 upper limit
  -  Bowel disease that causes malabsorption

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

Clinical trial: Airway Epithelium Gene Expression: AEGIS IDE

Summary: The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.

Detailed description: Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.

Eligibility: Inclusion Criteria:
  -  Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy
  -  All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form
  -  Patient must be a current or former cigarette smoker
  Exclusion Criteria:
  -  A pulmonary physician does not recommend that bronchoscopy be performed
  -  Inability to understand the written consent form and comply with requirements of the study
  -  History of prior primary lung cancer
  -  Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for >24 consecutive hours.

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 I/II Clinical Trial of Vidaza With Abraxane in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer

Summary: The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Detailed description: The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.

Eligibility: Inclusion Criteria:
  1. For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.
  2. For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
  3. Her-2/neu negative (Phase II)
  4. Negative pregnancy test for female subjects
  5. Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.
  6. Male or female for phase I and female for phase II, >19 years of age and any race.
  Exclusion Criteria:
  1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
  2. Known brain metastases
  3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
  4. Active infection requiring antibiotic therapy
  5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
  6. Grade 2 or greater motor or sensory neuropathy
  7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
  8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
  9. Known or suspected hypersensitivity to azacitidine or mannitol
  10. Pregnant or breast feeding
  11. Patients with advanced malignant hepatic tumors
  12. Malignancy other than breast carcinoma (phase II)
  13. Known HIV infection or chronic hepatitis B or C

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

Clinical trial: Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer

Summary: This is a two-part study. Part I is an observational study. Part II is a randomized clinical trial to see how well medical nutrition therapy works compared with standard care in treating patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.

Detailed description: In Part II of the study, patients are stratified according to tumor type (pancreatic vs lung vs prostate). Patients are then randomized to 1 of 2 arms.
  -  Arm I (Medical nutrition therapy): intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule.
  -  Arm II (standard care): Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
  In both arms, patients' weight, fat free mass, and Patient Generated Subjective Global Assessment Score (PG-SGA) score will be assessed before, during, and after the intervention. The PG-SGA includes a patient report of symptoms and a healthcare professional assessment of medical, metabolic, and physical parameters.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosed with one of the following:
  -  Pancreatic cancer
  -  Lung cancer
  -  Stage III or IV prostate cancer
  -  Undergoing treatment at The Cancer Institute of New Jersey
  -  Are undergoing chemotherapy (part 2 only)
  -  Has lost ≥ 5% of their usual body weight in the previous 6 months (part 2 only)
  PATIENT CHARACTERISTICS:
  -  Life expectancy > 60 days
  -  Must speak and read English
  -  Accessible in person or by phone for completing questionnaires
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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 Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


Eligibility: Inclusion Criteria:
  -  Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
  -  Prior use of Herceptin (trastuzumab), and a taxane
  -  Adequate cardiac and renal function
  Exclusion Criteria:
  -  More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
  -  Bone as the only site of disease
  -  Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
  -  Significant gastrointestinal disorder with diarrhea as major symptom

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

Clinical trial: Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

Summary: This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.


Eligibility: Inclusion Criteria:
  -  Advanced adenocarcinoma of lung, measurable disease
  -  Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
  -  patients with known EGFR activating mutation regardless of smoking status
  -  ECOG(Eastern Cooperative Oncology Group) 0-1.
  Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy
  Exclusion Criteria:
  -  Active brain metastases
  -  Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
  -  known EGFR wild type NSCLC

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

Clinical trial: A Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)

Summary: This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo. Patients assessed to have partial or complete response will continue on open-label ridaforolimus. Patients assessed to have disease progression will be discontinued from study.

Detailed description: Allocation and Arms Additional Information: All Patients will receive an 8-week
  open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)
  Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.

Eligibility: Inclusion Criteria:
  -  Patient has histologically confirmed stage IIIB/IV non-small cell lung cancer
  -  Patient has a documented mutation of the KRAS gene
  -  Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
  -  A minimum of 4 weeks has passed since the most recent anti-cancer treatment
  -  Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
  -  Patient has adequate organ function
  -  Patient has performance status of <=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
  -  Patient is >=18 years of age
  Exclusion Criteria:
  -  Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
  -  Patient is known to have active brain metastases
  -  Patient is currently participating or has participated in an investigational drug study within 30 days
  -  Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
  -  Patient has an active infection requiring prescribed intervention
  -  Patient has newly diagnosed or un-controlled Type 1 or 2 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: Fluorine-18-α-Methyltyrosine Positron Emission Tomography (18F-FMT PET) for Therapy Response in Lung Cancer

Summary: L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The investigators evaluated the value of 18F-FMT PET for the assessment of therapy response in patients with lung cancer as compared with that of 2-[18F]-fluoro-2-deoxy-D-glucose (18F-FDG) PET.
  The patients with lung cancer underwent PET studies with 18F-FDG and 18F-FMT before and after radio-/chemotherapy. The investigators used the ratio of the SUVmax of the mediastinal (N2) lymph node to the SUVmax of the primary tumor (N/P ratio ). All patients were divided into two groups of N/P ratio<1 and N/P ratio≥1, and the survival time was estimated by Kaplan-Meier method.


Eligibility: Inclusion Criteria:
  -  primary lung cancer All patients received first-line chemotherapy
  Exclusion Criteria:
  -  Patients with diabetus mellitus

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

Clinical trial: Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Summary: RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
  PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.
  Secondary
  -  To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.
  -  To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.
  OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
  -  Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
  Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
  Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.
  After completion of study treatment, patients are followed for 5 years.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed non-small cell lung cancer
  -  T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
  -  Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
  -  Age >= 18
  Exclusion Criteria:
  -  Prior thoracic radiation therapy
  -  T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
  -  Node positive or metastatic disease
  -  Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
  -  No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
  -  Pregnant or unwilling to use adequate contraception

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

Clinical trial: Level of HER2-neu Gene Amplification an Response to Trastuzumab

Summary: Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility: Inclusion Criteria:
  -  HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
  Exclusion Criteria:
  -  HER2-negative advanced breast cancer Pretreatment with trastuzumab

Relevance to patient case: not relevant