araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Summary: This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.

Detailed description: This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
  GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.

Eligibility: Inclusion Criteria:
  1. written informed consent
  2. 19 years or older
  3. patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
  4. high EGFR amplification
  5. available archive tumor sample(s)
  6. Karnofsky performance status (KPS) > 70
  7. life expectancy > 3 months
  8. adequate end-organ function
  9. patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)
  Exclusion Criteria:
  1. patients who had EGFR target agent(s) before screening
  2. patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)
  3. patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
  4. patients who had investigation drug(s) within previous 4 weeks
  5. patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)
  6. patients who had severe infection within previous 4 weeks
  7. HIV infection
  8. patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
  9. clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
  10. pregnancy or breast-feeding

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.

Summary: This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.
  For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).
  Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.
  Patients will be followed during the 3 cycles of treatment.


Eligibility: Inclusion Criteria:
  1. Age ≥ 18 years.
  2. Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
  3. Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
  4. Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
  5. OMS ≤ 2.
  6. For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
  7. Patient affiliated to a Social Health Insurance in France.
  8. Patient must provide written informed consent prior to any study specific procedures.
  Exclusion Criteria:
  1. Any previous treatment for metastatic disease.
  2. Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
  3. Patient with isolated hepatic metastasis.
  4. Patient with hemostasis disorders.
  5. Unbalanced Diabetes.
  6. Patient with usual formal contraindication to PET/TDM Imaging.
  7. Patient who has already started trastuzumab + pertuzumab + taxane treatment.
  8. Pregnant or breastfeeding women.
  9. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
  10. Patient protected by law.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Personal Sound Amplification Device

Summary: Find a personal sound amplification device that can help people hear better.

Detailed description: Personal sound amplification devices (PSADs) have recently become available to the public. PSADs serve a potentially important role in providing audibility of sounds for adults who find themselves having difficulty hearing and understanding speech in some daily living situations, but may not be candidates for traditional, high-amplification hearing aids. Despite hearing loss being a very common problem, few adults who could benefit from some level of amplification actually access the technology. Only approximately 1 in 7 adults (14%) over the age of 50 with a hearing loss using amplification. High cost is the most commonly cited reason for not wanting to try amplification, and indeed, hearing aids range from $1000 to $5000 each (i.e., per ear). PSADs range from $50-$600 each, and may provide a reasonable option for people who are not ready, or are unwilling, to wear a hearing aid. This project aims to examine the feasibility of a PSAD to provide audible and clear sound signal to adult listeners. The significance of this project is its potential to develop an option for individuals to take advantage of amplification and access sound to improve quality of life, who may not otherwise do so without this technology.

Eligibility: Inclusion Criteria:
  -  Adults who report difficulty hearing in some daily listening situations.
  -  Primarily English-speaking
  -  Able to follow instructions and perform study procedures.
  Exclusion Criteria:
  -  Children
  -  Non-English speaking
  -  Unable to perform research procedures and/or follow necessary instructions

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: SEMA4C as a Relapse Biomarker in Breast Cancer

Summary: Breast cancer remains the most common cancer in women worldwide. Semaphorin4C (SEMA4C) has previously been identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs). The objective of this study is to investigate SEMA4C's potential role as an early relapse biomarker in breast cancer.

Detailed description: Breast cancer remains the most common cancer in women worldwide, with approximately 1.68 million new cases, and 0.52 million deaths, annually. Meanwhile the incidence of breast cancer continues to increase. Although regular clinical examination, mammography, ultrasonography, and magnetic resonance imaging can detect some recurrence patients, the lack of robust biomarkers for monitoring of anti-tumor therapies and detection of recurrence reduce the treatment effectiveness of current strategies for breast cancer.
  Semaphorin4C (SEMA4C) has been previously identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (LECs) using in situ laser capture microdissection of lymphatic vessels, followed by cDNA microarray analysis. Moreover, membrane-bound SEMA4C is cleaved by matrix metalloproteinase (MMPs) to release a soluble form of this protein. The study is undertaken to explore SEMA4C's potential role as an early relapse biomarker in breast cancer.

Eligibility: Inclusion Criteria:
  -  Have histologically confirmed new diagnosis of breast cancer according to biopsy or surgery
  Exclusion Criteria:
  -  Patients who are not mentally capable of giving written informed consent
  -  Serum samples doesn't qualified
  -  Patients who refuse follow-up on their conditions
  -  Patients with prior cancer history
  -  Patients with a diagnosis of other severe acute or chronic medical may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Summary: The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.


Eligibility: Inclusion Criteria:
  -  Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1
  -  History of disabling migraine for at least 1 year
  -  Migraine onset before the age of 50 years
  -  History of 3 to 8 migraine attacks per month (<15 headache days per month) during the past 3 months
  -  MIDAS score ≥11
  -  Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
  -  Women of child-bearing potential must be using or willing to use a highly effective form of contraception
  -  Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed
  Exclusion Criteria:
  -  Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
  -  History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the participant at increased risk of seizures
  -  History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
  -  History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
  -  History of orthostatic hypotension with syncope
  -  Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
  -  Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
  -  History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month)
  -  Use of more than 3 doses per month of either opioids or barbiturates
  -  Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening
  -  Pregnant or breast-feeding women
  -  History of drug or alcohol abuse/dependence within 1 year prior to screening
  -  Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study
  -  Currently enrolled in any other clinical study involving an investigational product
  -  Relatives of, or staff directly reporting to, the Investigator
  -  Participants who are employees of the sponsor

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

Summary: This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.


Eligibility: Inclusion Criteria:
  -  Signed written informed consent obtained prior to study procedures
  -  Histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer
  -  Subjects must have previously received adequate standard therapy for treatment of their malignancy
  -  For those with metastatic breast cancer, must have received HER2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting
  -  For those with advanced gastric cancer, adequate prior treatment with HER2-directed chemotherapy is required
  -  At least 1 measurable lesion by iRECIST
  -  Able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-HER2 mAb-directed therapy
  -  ECOG of 0 or 1
  -  Life expectancy ≥ 6 months
  -  LVEF ≥ 50% by MUGA or ECHO
  -  Absolute neutrophil (ANC) count ≥ 1500/ µL
  -  Platelet count ≥ 100,000/µL
  -  Hemoglobin ≥ 9g/dL
  -  Estimated GFR >30mL/min/1.73m2
  Exclusion Criteria:
  -  glioblastoma multiforme or other primary CNS tumors are excluded
  -  clinically significant cardiac disease
  -  clinically significant active infection
  -  clinical history, prior diagnosis, or overt evidence of autoimmune disease
  -  current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid)
  -  Prior treatment as follows:
  -  prior cumulative doxorubicin dose greater than or equal to 300 mg/m^2 or equivalent
  -  chemotherapy within 2 weeks of enrollment
  -  external beam radiation within 2 weeks of enrollment (28 days if CNS-directed therapy)
  -  any monoclonal antibody (mAb) or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
  -  pertuzumab within 4 months of enrollment
  -  Experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter
  -  allogeneic hematopoietic stem cell transplant (HSCT)
  -  prior infusion of a genetically modified therapy
  -  Pregnant or breastfeeding

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: 500mg Fulvestrant in HR+ MBC

Summary: To study the real world use of 500mg Fulvestrant in HR+ MBC.

Detailed description: An observational, retrospective study of 500mg Fulvestrant in hormone receptor+/HER2- advanced breast cancer

Eligibility: Inclusion Criteria:
  1. Diagnosed with ER/PR+，HER2- advanced breast cancer
  2. Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
  3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015.
  4.Available medical history
  Exclusion Criteria:
  1. Incomplete medical history
  2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Nipple Aspirate Fluid in Detecting Breast Cancer

Summary: This trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations.

Detailed description: PRIMARY OBJECTIVES:
  I. To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least 40-years-old.
  II. To analyze the samples using a novel protein nanopore-based detection platform to evaluate the efficacy of the platform for breast cancer diagnosis through detection of biomarkers.
  OUTLINE:
  Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
  After completion of study, participants are followed up at 1 year.

Eligibility: Inclusion Criteria:
  -  BREAST CANCER: Must be > 1 year from pregnancy, lactation.
  -  BREAST CANCER: Must be currently diagnosed with known breast cancer in breast.
  -  BREAST CANCER: Must not be currently diagnosed with cancers other than breast cancer.
  -  BREAST CANCER: Must not have been gone through surgery, radiotherapy or chemotherapy within 30 days of enrollment.
  -  HEALTHY SUBJECTS: No history of breast cancer and must not be currently diagnosed with any other cancer.
  -  HEALTHY SUBJECTS: Must be > 1 year from pregnancy, lactation.
  -  HEALTHY SUBJECTS: Must be willing to have a clinical breast exam and/or mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the James Cancer Hospital within the past 90 days prior to their NAF procedure. The clinical breast exam result and/or mammograms must be read as not suspicious for breast cancer.
  -  HEALTHY SUBJECTS: Must be willing to keep the clinic informed of their breast health status for 1 year.
  Exclusion Criteria:
  -  Subjects who are currently pregnant, lactating, or within a year of pregnancy/lactation. Pregnancy testing will not be required of any patients over 60 years of age, or any patient who has undergone bilateral oophorectomy.
  -  Subjects who currently are diagnosed with cancers other than breast cancer.
  -  Subjects who cannot give an informed consent.
  -  Male gender of any age.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel in Patients With HER2 Positive Breast Cancer

Summary: Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Detailed description: Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Eligibility: Inclusion Criteria:
  1. female patients, 18 years ≤ age ≤ 75 years.
  2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.
  3. Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
  4. HER2 positive (HER2+++ by IHC or FISH+)
  5. Life expectancy of more than 3 months
  6. Known hormone receptor status.
  7. Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.
  8. Signed the informed consent form prior to patient entry.
  Exclusion Criteria:
  1. metastatic disease (Stage IV) or inflammatory breast cancer.
  2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
  3. clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
  4. Unable or unwilling to swallow tablets.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

Summary: This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.


Eligibility: Inclusion Criteria:
  1. BRAF V600 mutation in solid tumor.
  2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
  3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment.
  4. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
  5. ECOG performance status of 0-1.
  6. Life expectancy ≥ 3 months.
  7. Ability to take the medicine orally.
  8. Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. Hypersensitivity to study drug ingredients or their analogues.
  2. Prior therapy with MEK-inhibitor.
  3. Receiving any other anti-cancer therapy at the same time .
  4. Active central nervous system (CNS) lesion.
  5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
  6. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；
  7. Uncontrolled concomitant diseases or infectious diseases.
  8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
  9. History of HIV,HCV,HBV infection.
  10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
  11. Serum HCG test is positive.
  12. Other conditions that increase the risk of study and influence the result.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

Summary: This is a multi-center, observational genomic screening protocol to identify patients whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Patients with histologically confirmed metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 3 to 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible patients and ctDNA will be extracted and sequenced at a central laboratory, using HER2-targeted next generation sequencing (NGS). A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Patients who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.


Eligibility: Inclusion Criteria:
  1. Women and men who are ≥18 years old at signing of informed consent
  2. Histologically-confirmed metastatic breast or metastatic cervical cancer
  3. Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  4. Provide written informed consent to participate in the study and for circulating tumor DNA screening
  5. Must be able to provide blood sample(s) for HER2 mutation testing
  Exclusion Criteria:
  1. Breast cancer patients with known HER2+ or HER2-amplified tumors
  2. Patients who have received neratinib

Relevance to patient case: not relevant