araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Summary: This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.

Detailed description: PRIMARY OBJECTIVES:
  I. To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities.
  SECONDARY OBJECTIVES:
  I. To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs.
  OUTLINE: Patients are randomized to 1 of 2 arms.
  ARM A: Patients receive usual care.
  ARM B: Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.
  After completion of study, patients are followed up for 6 months.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed patients for the following conditions
  -  Colon cancer stage III and IV
  -  Rectal cancer stage II, III, IV
  -  Glioblastoma multiforme (brain) -- no stage
  -  Non-small cell lung cancer stage IIIA, IIIB, IV
  -  Small cell lung cancer, limited stage and extensive stage
  -  Castration-resistant prostate cancer
  -  Head and neck cancer stage III and IV
  -  Gastric cancer stage III and IV
  -  Esophageal cancer stage III and IV
  -  Pancreatic cancer stage II, III, IV
  -  Renal cell carcinoma, stage IV
  -  Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy
  -  Sarcoma, stage IV
  -  Bladder carcinoma, stage IV
  -  Acute myeloid leukemia
  -  Melanoma, stage III and IV
  -  Ovarian cancer, stage III and IV
  -  High grade myelodysplastic syndrome (MDS)
  -  Any patient with recurrent or progressive cancer
  -  Patients must have the ability to understand and willingness to sign a written informed consent document
  -  Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care
  Exclusion Criteria:
  -  Patients must have capacity to consent
  -  Pregnant patients are excluded

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Phase II Trial of AZD2014 in RICTOR Amplified Solid Cancer Patients Refractory to Standard Chemotherapy

Summary: Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014). Study-arm is composed of 27 patients.
  Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

Detailed description: Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014). Study-arm is composed of 27 patients.
  Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).
  Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Patients may continue vistusertib(AZD2014) beyond progression (according to RECIST 1.1), at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria.
  If a patient discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival.
  Assessments for survival should be made every 8 weeks following objective disease progression. The details of first and subsequent therapies for cancer, after discontinuation of treatment, will be collected.

Eligibility: Inclusion Criteria:
  1. Advanced solid cancers (including histologically or cytologically documented gastric cancer, colorectal cancer, hepatoma, biliary tract cancers, pancreatic cancer and rare cancers.) that has progressed after standard chemotherapy.
  - Rare cancers are defined as sarcoma, neuroendocrine carcinoma
  2. Provision of tumor sample tumor sample tumor sample tumor sampletumor sample (from either a resection or biopsy)
  3. Patients with RICTOR amplification through NGS.
  4. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  Exclusion Criteria:
  1. Patients not having received recommended treatment-lines and chemotherapy regimen for the treatment of each tumor type in the advanced setting.
  2. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
  3. HER2 positive AGC patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Predicting Biomarker of Gastric Cancer Chemotherapy Response

Summary: -  discovery and validation of biomarker predicting gastric cancer chemotherapy response
  -  Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response
  -  Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response
  -  Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort
  -  Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response

Detailed description: -  discovery and validation of biomarker predicting gastric cancer chemotherapy response
  -  Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group Palliative chemotherapy (inoperable patients)
  -  institutional primary Chemotherapy regimen (XP or Xelox)
  1. response group
  2. progression group
  Post-OP adjuvant chemotherapy
  -  institutional primary Chemotherapy regimen
  1. complete response group
  2. non-responder group
  1. and 2) groups: age, sex, regimen matched
  -  Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group
  -  the same patients in mRNA sequencing
  -  Validation of mRNA and miRNA in multiple independent cohort method of measurement of RNA expression: qRT-PCR
  -  Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response combination of biologic biomarker and clinical factors to predict the chemotherapy response in gastric cancer

Eligibility: Inclusion Criteria:
  -  new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
  -  patients who agreed this study and voluntarily assigned the informed consents.
  Exclusion Criteria:
  -  patients who refused the study.
  -  patients who have other cancers
  -  heavy alcoholics

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

Summary: The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive solid tumors. The study will expand to look at the selected dose in patients with breast cancer, gastric cancer and non-small cell lung cancer


Eligibility: Inclusion Criteria:
  -  HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available
  -  Performance status of 0 or 1
  -  Adequate bone marrow, kidney and liver function
  Exclusion Criteria:
  -  Known CNS disease including, but not limited to, metastases
  -  History of exposure to certain cumulative doses of anthracyclines
  -  Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
  -  Active and clinically significant bacterial, fungal, or viral infection
  -  Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
  -  Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors

Summary: This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows:
  -  Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
  -  Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
  -  Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.


Eligibility: Inclusion Criteria:
  1. Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
  2. Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
  3. Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
  4. Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
  5. Presence of measurable disease by RECIST 1.1
  6. Life expectancy of at least 3 months.
  7. Provision of signed and dated informed consent form (ICF).
  8. Stated willingness to comply with study procedures and duration.
  Exclusion Criteria:
  1. Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
  2. Eastern Cooperative Oncology Group (ECOG) performance status >2.
  3. Evidence of insufficient organ function as determined by the protocol.
  4. Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab.
  5. Have central nervous system disease (CNS) as follows:
  1. Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases.
  2. MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months.
  6. Myocardial infarction (MI) within 6 months of Screening Visit.
  7. Severe asthma.
  8. Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
  9. Uncontrolled infections.
  10. Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma

Summary: The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.

Detailed description: The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.

Eligibility: Inclusion Criteria:
  -  Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:
  -  Willing to sign ICF
  -  Above 18 years
  -  KPS score≥70
  -  Expected survival time more than 90 days
  -  Subjects with EGFR overexpression (2+ or 3+ in IHC)
  -  With target lesions in spiral CT or MRI examination within 30 days
  -  Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent.
  -  Lab test of baseline meet following criteria
  -  Hemoglobin higher than 9.0g/dL
  -  Neutrophil higher than 1,500/mm3
  -  PLT higher than 10.0 104/mm3
  -  Bilirubin lower than 1.5 times of upper limit of normal range
  -  AST,ALT,ALP lower than 2.5 times of upper limit of normal range
  -  Creatinine lower than upper limit of normal range
  -  When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range
  Exclusion Criteria:
  -  Patients who have received irinotecan
  -  Patients who are allergic to irinotecan or nimotuzumab.
  -  Other active malignancy within the last 5 years
  -  Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
  -  Investigator judge not eligible to this trial

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

Summary: This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.


Eligibility: Inclusion Criteria:
  1. Male or females with an age ≥ 18 years.
  2. Subjects with histological- or cytological-confirmed, advanced cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists
  1. For Phase 1, only subjects HER2 or HER3 molecular/genetic alterations will be enrolled.
  2. For Phase 2a, subjects with one of the following tumor types will be enrolled:
  i. Urothelial cancer with HER2 or HER3 mutation ii. Biliary tract cancer with HER2 or HER3 mutation iii. Breast cancer with HER2 or HER3 mutation iv. Breast cancer with HER2 amplification or overexpression v. NSCLC with HER2 or HER3 mutation vi. CRC with HER2 mutation or amplification vii. Other tumors with HER2 mutation/amplification/overexpression or HER3 mutation (gastric/GEJ, endometrial).
  3. At least 1 measurable lesion for solid tumor
  4. Is able to take medications orally (e.g., no feeding tube).
  5. Able to agree to and sign informed consent and to comply with the protocol
  6. Has adequate organ function
  Exclusion Criteria:
  1. Has a serious illness or medical condition(s)
  2. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration
  3. Impaired cardiac function or clinically significant cardiac disease

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer

Summary: This study will treat patients with advanced NSCLC who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy and in combination with Osimertinib.

Detailed description: A phase I/II, open-label, multicentre study to investigate the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD4205 as monotherapy or in combination with Osimertinib in patients with EGFR mutant advanced stage non-small cell lung cancer (NSCLC). This study includes dose escalation part and dose expansion part.

Eligibility: Inclusion Criteria:
  1. Obtained written informed consent
  2. Patients must have histological or cytological confirmation of activating EGFR mutation positive NSCLC and have failed prior EGFR TKIs treatment.
  3. Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  4. Adequate bone marrow reserve and organ system functions
  Exclusion Criteria:
  1. Any unsolved toxicity > CTCAE grade 1 from previous anti-cancer therapy (except alopecia)
  2. Active viral or bacterial infections;
  3. Active or latent tuberculosis;
  4. History of interstitial lung disease (ILD)
  5. History of heart failure or QT interval prolongation
  6. Immunodeficiency diseases;
  7. Active CNS metastases
  8. Treatment with an EGFR TKI (e.g., erlotinib or gefitinib) within 8 days or approximately 5 x half-life, whichever is longer, of the first dose of study treatment

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy

Summary: Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered as a single agent and then in combination with endocrine therapy. The study contains two parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding component and a Part 2 dose expansion as both a single agent and in combination with endocrine therapy.

Detailed description: This is a Phase 1/2a, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-06873600 administered as a single agent in sequential dose levels and then in combination with endocrine therapy. In Part 1A, successive cohorts of patients will receive escalating doses of PF-06873600 and then in dose finding (Part 1B) with PF-06873600 in combination with endocrine therapy (ET). This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-06873600 in combination with endocrine therapy (Part 1B) followed by dose expansion arms as a single agent and PF-06873600 in combination with endocrine therapy (Part 2).

Eligibility: Inclusion Criteria:
  -  Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer
  • Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy
  -  Have a diagnosis of metastatic triple negative breast cancer (TNBC)
  • Up to 1-2 prior lines of chemotherapy
  -  Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC)
  • Up to 2-3 prior lines of therapy
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  -  Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
  -  Measurable disease as defined by RECIST 1.1 is required (Part 2)
  Exclusion Criteria:
  -  Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
  -  Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  -  Major surgery or radiation within 4 weeks prior to study entry
  -  Last anti-cancer treatment within 2 weeks prior to study entry
  -  Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
  -  Pregnant or breastfeeding female patients
  -  Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease

Relevance to patient case: not relevant