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

Clinical trial: Brain Metastasis in Breast Cancer Patients

Summary: The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.

Detailed description: A retrospective cohort study will be conducted in the Henry Ford Health System (HFHS). Using medical record review, we will identify all women diagnosed with advanced stage (stage III and IV) breast cancer between January 1, 1995- December 31, 2007. For each case included in the study, we will obtain data on demographics, tumor information, treatment related medical encounters and procedures, and occurrence and timing of brain and/or other distant metastases. The main outcome for this study is the development of distant metastases. Each patient in the cohort will be classified as to the occurrence and date of distant metastases. Metastases will be classified as Brain, Distant lymph node, Lung/pleural effusion, Liver, Bone, Other visceral, Other non-visceral.
  Other secondary outcomes to be explored include:
  -  Survival after advanced breast cancer—time in months from the date of advanced stage breast cancer diagnosis until death or end of study period
  -  Time to brain metastases—time in month from the date of advanced stage breast cancer diagnosis until brain metastases diagnosis
  -  Survival after brain metastases—time in months from the date of diagnosis of brain metastases until death or end of study period

Eligibility: Inclusion Criteria:
  -  Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007;
  -  At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
  -  Age 30 years or older at diagnosis.
  Exclusion Criteria:
  -  Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
  -  Age less than 30 years or older at diagnosis.

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

Clinical trial: A Retrospective Study of Biomarkers in Non-Small Cell Lung Cancer

Summary: The purpose of this study is:
  1. To characterize the types and frequency of molecular alterations to the epidermal growth factor receptor (EGFR) pathway, FGFR4 and EML-ALK in Asian patients with non-small cell lung cancer
  2. To identify candidate biomarkers of importance in the EGFR and estrogen pathways
  Most, if not all, human malignancies including lung cancer are caused by somatic alterations of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes and their resultant oncogenic effects. In addition to mutations, increased chromosomal copy number (by amplification or polysomy) and DNA methylation are other mechanisms of oncogene activation and tumour suppressor gene inactivation respectively.
  Little is known about the relationship between these oncogenes of the EGFR family and the recently described oncogenes FGFR4 and fusion gene EML4-ALK. Recent data suggests molecularly defined subgroups of non-small cell lung cancer (NSCLC) exist and can be used to predict for sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy (pemetrexate, gemcitabine, platinum agents). The findings that estrogen receptors are present in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in vitro and in vivo are provocative. Further studies to evaluate the role of estrogens and other sex hormones in lung cancer are warranted.
  A further understanding of the molecular indicators of lung cancer prognosis and treatment prediction would improve drug development and patient treatment selection.
  Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology and the National University Tissue Repository respectively. Clinico-pathological characteristics will be obtained from the case records, Pathology and Tissue Repository. DNA will be isolated using standard techniques. Sequencing of genes in the EGFR signaling pathway: EGFR, KRAS, ErbB2, ErbB3, MET, PI3K, and BRAF as well as FGFR4. Unstained slides from the paraffin-embedded tissue will be obtained and subjected to fluoresce in vitro hybridization (FISH) for breakpoints in the EML4 and ALK genes as previously described. For cases that have been snap-frozen, RNA will be extracted and EML4-ALK fusions will be confirmed using RT-PCR and pre-specified primers. To analyse the expression of proteins of putative relevance to EGFR function (such as EGFR, ErbB2, ErbB3, AKT, MET, STAT, ERK, MAPK, cyclin D1, C/EBPa), downstream effects of EGFR: cell proliferation (Ki-67), angiogenesis (CD34, VEGF-A), apoptosis (bcl-2), metastasis, and hormonal influence (oestrogen and progesterone receptors, aromatase), TMA technology will be utilised. The status of the tumor suppressor genes PTEN and C/EBPa will be analysed.


Eligibility: Inclusion Criteria:
  Exclusion Criteria:

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

Clinical trial: Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

Summary: The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA combined with chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

Detailed description: Percutaneous image-guided RFA is a minimally invasive technique used to treat solid tumours. Because of its ability to produce large volumes of coagulation necrosis in a controlled fashion, this technique has gained acceptance as a viable therapeutic option for unresectable liver malignancies. Recently, RFA has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RFA in the destruction of experimentally-induced pulmonary malignancies. Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response. We designed a prospective clinical trial aimed at assessing feasibility, safety and effectiveness of RFA combined with chemotherapy in the treatment of lung malignancies.

Eligibility: Inclusion Criteria:
  -  adult (> 18 years) male or female patient
  -  patient has biopsy-proven NSCLC or lung metastasis
  -  patient has been rejected for surgery and has been considered unfit for radiation therapy
  -  each 6 cm or smaller in greatest diameter of tumor, by CT scan
  -  tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
  -  tumors are accessible by percutaneous route
  -  patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  -  patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5
  -  patient has signed written informed consent prior to any study specific procedures.
  Exclusion Criteria:
  -  patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
  -  patient has more than 3 tumors / lung
  -  patient has at least one tumor > 6 cm in greatest diameter
  -  tumor is associated with atelectasis or obstructive pneumonitis
  -  patient has renal failure requiring hemodialysis or peritoneal dialysis
  -  patient has active clinically serious infection
  -  patient has history of organ allograft
  -  patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
  -  patient is pregnant or breast-feeding
  -  patient has ECOG performance status > 2
  -  patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.

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

Clinical trial: Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy

Summary: The patients from 12 centers were included into the study. pN2 patients received PORT, pN1 patients did not. PORT was 3D-planned and consisted in 54-56 Gy in 27-28 fractions. One month after surgery, all patients completed EORTC QLQ C-30 questionnaires and had pulmonary function tests (PFT); cardiopulmonary symptoms were assessed by modified LENT-SOM score. Two years after, all patients free of disease repeated the same examinations. Changes in QLQ, LENT-SOM score and the results of PFT were compared for patients receiving and not PORT.


Eligibility: Inclusion Criteria:
  -  complete resection by lobectomy, bi-lobectomy or pneumonectomy of NSCLC,
  -  pN1 or pN2 disease,
  -  signed informed consent for participation in the study,
  -  Karnofsky Performance Status (KPS) higher than 70%.
  Exclusion Criteria:
  -  presence of distant metastases,
  -  N2 diagnosed before surgery in imaging and/or mediastinoscopy,
  -  previous radiotherapy to the chest,
  -  no or inadequate mediastinal nodal dissection ,
  -  FEV1 after surgery lower than 1.0 liter,
  -  any active infectious process (including fistula formation) in the chest

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

Clinical trial: A Phase I Study of AZD1480 in Patients With Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the Escalation Phase,Non-Small Cell Lung Cancer(NSCLC) and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour in the Expansion Phase.

Summary: This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and BID dosing.


Eligibility: Inclusion Criteria:
  -  Male or female aged 18 years or older
  -  For Part A and C: Histological or cytological confirmation of a solid malignant tumour refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma & HCC are excluded.
  -  For Expansion : Histological or cytological confirmation of
  -  Expansion 1: EGFR and/or ROS mutant NSCLC or Non-smokers with lung metastasis
  -  Expansion 2: Gastric cancer or solid tumour with biopsy available (consenting paired biopsies)refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma & HCC are excluded.
  -  For Part B : Advanced or metastatic HCC, unresectable and incurable with ablative therapy or TACE, with no standard therapy available.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks
  -  For Part B : Child-Pugh liver function status classified as A to B7
  Exclusion Criteria:
  -  For any other chemotherapy, immunotherapy or anticancer agents, within 5 half lives or 3 weeks must have elapsed from treatment to of the first dose of investigational product, whichever is shorter.
  -  With the exception of alopecia, any unresolved toxicities from prior therapy ≥ Grade 2 of CTCAE V4.02 at the time of starting study (except LFTs for HCC patients, which may be Grade 2 at the time of starting the study)
  -  Any of the following conditions:Interferon treatment for HBV and HCV Prior Liver Transplantation
  -  Inadequate bone marrow reserve or organ function as demonstrated by laboratory values
  -  Evidence of established interstitial lung disease(ILD) on baseline high resolution computerized tomography(HRCT)

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

Clinical trial: Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib

Summary: The purpose of this study is to understand how information of 3 specific biomarkers can provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.


Eligibility: Inclusion Criteria:
  1. HER2-positive (defined as either (a) IHC3+ or (b) FISH+ in local lab) recurrent / metastatic breast cancer patients who have received treatment with lapatinib-based regimen. These are either new, current or completed cases from any of the following settings:
  -  treated according to physician's clinical judgement in routine practice; or
  -  treated in clinical trials with known allocation to lapatinib-based regimen; or
  -  treated via lapatinib expanded access or named patient programs. These regimens should contain lapatinib as the only anti-HER2 agent.
  2. Exposed to < 2 lines of trastuzumab-based regimen in the metastatic setting prior to start of lapatinib-based regimen. These regimens should contain trastuzumab as the only anti-HER2 agent.
  3. Patients with an historical tumor biopsy specimen available from their primary breast cancer diagnosis. If this is not available, then at least a specimen should be available anytime during the period before the patient started on any anti-HER2 therapy.
  4. Willing to give written informed consent to release the tumor biopsy specimen with corresponding clinical data. If consent could be waived according to institutional practice (eg. patient already deceased, or patient previously provided blanket consent for institution to utilize tissue/data for research purpose), this is accepted with appropriate supporting documentation.
  Exclusion Criteria:
  1. Patients who have been exposed to other experimental anti-HER2 therapy eg. pertuzumab, trastuzumab-DM, neratinib, ertumaxomab, AV-412, BIBW2992, CUDC-101, anti-HER2 vaccines.
  2. Other primary lesions that are not of breast origin.

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

Clinical trial: GWAS Research of Lung Cancer in Tianjin

Summary: To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin Population.

Detailed description: Eligibility criteria:
  -  nonsmoker
  -  female
  -  age between 35 and 80
  -  no other types of tumors history
  -  frequency-matched cases and controls on gender and age
  Outcome measures:
  -  OR(odds ratio)
  -  RR(risk ratio)
  -  CI(confidence interval)
  -  SAS software

Eligibility: Inclusion Criteria:
  -  Non-small cell lung cancer
  -  Age from 35 to 80 years old
  -  Female
  -  Non-smokers
  -  Frequency-matched on age and gender
  Exclusion Criteria:
  -  Previous medical history of cancer
  -  Previous radiotherapy
  -  Previous chemotherapy

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

Clinical trial: Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion

Summary: The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.

Detailed description: 1. The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
  2. Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
  3. The enriched cancer cells are flash frozen and stored at -80℃ until processing.
  4. The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
  5. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility: Inclusion Criteria:
  -  Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion
  -  an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  -  At least one measurable lesion;
  -  Normal cardiac, hepatic, renal and bone marrow functions;
  -  Life expectancy ≥3 months;
  -  Discontinuity of previous chemotherapy for a minimum of 4 weeks.
  -  Not receive chemotherapy in pleural cavity
  Exclusion Criteria:
  -  previous history of other malignancies;
  -  previous surgery history on the needle biopsy organ;
  -  Serious or uncontrolled concurrent medical illness.

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

Clinical trial: A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer

Summary: This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/=18 years of age
  -  Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
  -  Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
  -  HER2 positive tumor (primary tumor or metastasis
  -  ECOG Performance status 0, 1 or 2
  -  Life expectancy of at least 3 months
  Exclusion Criteria:
  -  Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
  -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
  -  Patients with active (significant or uncontrolled) gastrointestinal bleeding
  -  Residual relevant toxicity resulting from previous chemotherapy
  -  Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)

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

Clinical trial: Targeting ER-Golgi Homeostasis in an Advantageous Therapeutic Strategy in Lung Cancer

Summary: Lung cancer remains the most common cause of cancer-related death in the world. The major advances in treatment of lung cancer have brought only minor improvements in survival therefore novel systemic treatment methods are urgently needed.
  Protein levels are regulated by the protein homeostasis network that generates and protects the protein fold (ER and Golgi included).
  The heat shock protein 90 (Hsp90) is an essential molecular chaperon involved in the posttranslational folding and stability of proteins. Hsp90 inhibition leads to accumulation of unfolded proteins and ER stress. The therapeutic efficacy of such inhibition may be augmented by co-administering it with other drugs that disrupt ER-Golgi homeostasis like histone deacetylase (HDAC) or proteasome inhibitors. ER-Golgi homeostasis disruption affects a wide network of proteins and pathways as such affords a systemic target. Thus, the investigators aimed to examine the effect of combined treatment of Hsp90 antagonist with proteasome or HDAC inhibitors on human lung cancer cell lines and primary cells.


Eligibility: Inclusion Criteria:
  -  PATIENTS WITH PROVED DIAGNOSIS OF LUNG CARCINOMA THAT ARE CANDIDATS FOR RADICAL SURGICAL TREATMENT
  Exclusion Criteria:
  -  PATIENTS WITH SUSPICION FOR LUNG CARCINOMA WITHOUT PATHOLOGYCAL DIAFNOSIS BEFORE SURGERY

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

Clinical trial: Role of Early Versus Late Switch to Lapatinib-Capecitabine

Summary: The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).

Detailed description: All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting can participate in this observational study, for a period of 12 months of observation since the start of the lapatinib-capecitabine treatment.

Eligibility: -  Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice);
  -  Older than 18 years old;
  -  Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer;
  -  Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment;
  -  Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, in the community setting;
  -  Signed consent to participate and release information for this study.

Relevance to patient case: not relevant