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

Clinical trial: Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

Summary: This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.

Detailed description: This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with NSCLC who have documented somatic HER2 mutations. Patients will be randomized at study entry into 1 of 2 treatment arms:
  -  Arm A: neratinib 240 mg orally once daily,
  -  Arm B: neratinib 240 mg orally once daily plus temsirolimus 8 mg once weekly by intravenous (IV) infusion.
  In the case of disease progression, patients initially assigned to the neratinib monotherapy arm will be given the option to add temsirolimus 8 mg IV once weekly.
  All patients on combination therapy may be dose-escalated with respect to temsirolimus dose to 15 mg/week at the end of first cycle of treatment with the combination, if well tolerated and at the physician's discretion. In the event that the neratinib 240 mg/day plus temsirolimus 15 mg/week dose is not well tolerated, the patient will be subsequently dose reduced back to neratinib 240 mg/day plus temsirolimus 8 mg/week.
  Dosing will be continuous on nominal 3-week cycles until evidence of progressive disease, unacceptable toxicity, or patient withdrawal of consent.
  All eligible patients enrolled will have their disease measured radiographically at baseline. Patients will undergo radiographic evaluation of their disease every 6 weeks until disease progression or withdrawal from the study.

Eligibility: Inclusion Criteria:
  -  Aged ≥18 years at the time of signing the informed consent.
  -  Histologically confirmed diagnosis of NSCLC, advanced (stage IIIB) or metastatic (stage IV).
  -  Documented somatic ErbB2 (HER2) activating mutation.
  Exclusion Criteria:
  -  Previous treatment with any investigational agent ≤30 days prior to the initiation of investigational products.
  -  Prior exposure to neratinib or mTOR inhibitor
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Relevance to patient case: possibly relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Clinical Value of 89Zr-trastuzumab PET

Summary: Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool.
  In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.


Eligibility: Inclusion Criteria:
  1. Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:
  -  HER2 immunohistochemical score of 3+, or
  -  HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
  In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification.
  2. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
  -  in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and
  -  in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
  3. Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET.
  4. Age >18 years of age.
  5. WHO performance status 0-2.
  6. Signed written informed consent.
  7. Able to comply with the protocol.
  Exclusion Criteria:
  1. Pregnant or lactating women.
  2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
  3. Inability to comply with study procedures

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 iPS Cell Generation From Patients With COPD

Summary: As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.


Eligibility: Inclusion Criteria:
  -  Undergoing Thoracic Surgery at the Mayo Clinic Rochester
  -  Presence of a Thoracic Disease

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 LJM716 in Japanese Patients With Advanced Solid Tumors

Summary: This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

Detailed description: This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.

Eligibility: Inclusion Criteria:
  1. Patients with the following indications:
  i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
  -  For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
  -  For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
  2. ECOG Performance Status of 0-2
  3. Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
  4. Willingness and ability to comply with all study procedures
  5. Written informed consent obtained prior to any screening procedures
  6. During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria

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

Clinical trial: An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Summary: Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  EGFR mutation or six months or longer benefit from EGFR TKIs
  -  Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
  -  Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.
  Exclusion Criteria:
  -  Inability to take oral drugs

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

Clinical trial: Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer

Summary: Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy Doxorubicin and the safety and potential efficacy of this combination will be explored in patients with HER2 Negative Metastatic Breast Cancer.


Eligibility: Inclusion Criteria:
  1. Biopsy proven HER2 negative metastatic breast cancer (dose escalation portion and MTD expansion portion) or advanced solid tumor (dose escalation portion).
  2. ASS deficiency (defined as <50% ASS expression) demonstrated on tissue specimen by Immunohistochemistry (IHC). Cytology and fine need aspirate specimens are not acceptable for ASS testing.
  3. Unresectable disease or subject refused surgery.
  4. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
  5. Failed available therapy known to confer clinical benefit but no more than 4 prior lines of chemotherapy for metastatic disease.
  6. Time to treatment failure from doxorubicin containing regimen ≥ 12 months if previously treated with doxorubicin.
  7. Age ≥ 18 years.
  8. ECOG performance status of 0 - 2. -
  Exclusion Criteria:
  1. Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
  2. Prior epirubicin exposure of > 600 mg/m2.
  3. Pregnancy or lactation.
  4. Expected non-compliance.
  5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
  6. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and Investigator may be allowed upon agreement with both.
  7. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of breast cancer diagnosis.
  8. Subjects who had been treated with ADI-PEG 20 previously.

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

Clinical trial: An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

Summary: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti -cancer therapy.
  Treatment will consist of neratinib alone 240 mg daily in all HER2 mutated cancers excluding hormone positive breast cancers and bladder cancers, or neratinib 240 mg daily and paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle in bladder cancers , or neratinib 240 mg daily and fulvestrant 500 mg on Days 1, 15 of the first month, then Day 1 of every 4 week cycle in hormone positive breast cancers.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

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

Clinical trial: Correlation Research of Thioredoxin Reductase in Lung Cancer

Summary: In pre-clinical study the investigators found that the thioredoxin reductase activity of serum harbours huge difference between cancer patients and non-cancer patients, the enzyme activity elevated remarkably among cancer patients, so the investigators hypothesis that this is due to tumor cells loading of the patients, the enzyme activity may harbours huge difference between carcinoma tissues and para-carcinoma tissues in early staged non-small cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level because of removing of tumor.

Detailed description: This is a cooperative research project in Thoracic Surgery Department and Medical Oncology Department of Affiliated Cancer Hospital of xiangya School of Medicine Central South University, and the State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking University. The primary objective is to measure the thioredoxin reductase activity using blood and lung cancer tissue and measure thioredoxin reductase messenger ribonucleic acid (mRNA) and protein expression using lung cancer and pericarcinomatous tissue in early staged(Ⅰ~ⅢA) non-small lung cancers, to study the correlations of thioredoxin reductase between blood and tissue. The secondary objectives are to measure the thioredoxin reductase activity between non small lung cancers and lung benign lesion patients to identify the difference between tumor and lung benign mass.

Eligibility: Inclusion Criteria:
  -  Pathologically proven staged(Ⅰ~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass
  -  Receive surgery in Thoracic Oncology department Hunan Tumor Hospital without contraindication of surgery
  -  Malignant tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before）
  -  Signed informed consent about providing blood and tissue for study
  Exclusion Criteria:
  -  Patients have received antitumor treatment
  -  Patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy
  -  Pregnant or breast feeding women

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

Clinical trial: A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)

Summary: The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line treatment setting. The hypothesis to be tested in this study is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of breast cancer.
  -  Presence of metastatic disease.
  -  Documentation of HER2 gene amplification or overexpression.
  -  Available tumor tissue for central review of HER2 status.
  -  At least 1 measurable lesion as defined by RECIST 1.1.
  -  Eastern Cooperative Oncology Group status of 0 to 2.
  -  Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.
  Exclusion Criteria:
  -  Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization.
  -  Prior systemic therapy for metastatic disease (except endocrine therapy).
  -  Prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m^2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m^2 of doxorubicin.
  -  Inflammatory breast cancer.
  -  Active uncontrolled or symptomatic central nervous system metastases.

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

Clinical trial: A Retrospective Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in Non-small Cell Lung Cancer(NSCLC)Treatment

Summary: For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.

Detailed description: The ADME-associated SNPs included are CYP3A4,CYP3A4,CYP1A1,CYP2D6, ABCB1,ABCG2 and so on .The somatic mutations included are EGFR ,K-RAS ,ALK and so on

Eligibility: Inclusion Criteria:
  The main patient entry criteria included: age≥ 18 years ; histologically and cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:
  uncontrolled systemic disease ,any evidence of clinically active interstitial lung diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.

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

Clinical trial: Biomarkers for Diagnosis of Lung Cancer

Summary: The study goal is to collect blood samples from individuals at risk for lung cancer in order to identify protein markers for diagnosis of lung cancer in the Chinese population.


Eligibility: Inclusion Criteria:
  -  Adults ≥ 18 years of age
  -  Patients referred to pulmonologists, oncologists, or thoracic surgeons for diagnosis of suspicious pulmonary nodules as either lung cancer or benign and undergoing bronchoscopic biopsy
  -  Patients will be enrolled if the result of the bronchoscopic biopsy is a diagnosis of NSCLC or benign pulmonary nodule
  -  Cases: Patients with untreated non-small cell lung cancer, i.e. primary lung adenocarcinoma or squamous cell carcinoma of early
  -  Computed tomography or X-Ray is available and shows a suspicious pulmonary nodule
  -  A biopsy or surgical resection to clarify the nature of the lung nodule is available (NSCLC or benign, including histological diagnosis) in both groups
  -  Controls: Patients must be available for a 6 month follow-up to confirm benign diagnosis
  -  A serum and plasma sample was collected prior to any treatment of the lung nodule beyond biopsy
  -  No other cancer diagnosis in the last 5 years excluding non-melanoma skin cancer
  -  Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.
  Exclusion Criteria:
  -  Prior treatment for lung cancer by chemotherapy or surgery (excluding biopsy)
  -  Patients with benign nodules who are not able or willing to have a 6-month follow-up visit to confirm benign diagnosis
  -  Diagnosis or treatment of other cancer in the last 5 years excluding non-melanoma skin cancer. In the judgment of the clinical investigator, patients who are likely to be non compliant or uncooperative during the study.

Relevance to patient case: not relevant