araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

Summary: Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.


Eligibility: Inclusion Criteria:
  -  Adult female patients (n=10) with biopsy-proven HER2-positive, with at least one FDG positive lesion by PERCIST
  -  Be at least 18 years of age
  -  Patients eligible for neoadjuvant therapy using a regimen containing at least one anti-HER2 agent (stage 2 and 3 HER2+ breast cancer)
  -  ECOG performance status of 0 and 1
  -  Ejection fraction greater than 50% by echocardiogram or MUGA scans
  -  Be enrolled in the I-SPY 2 trial
  Exclusion Criteria:
  -  Pregnant women and patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or unable to tolerate up to 60 min of PET imaging per imaging session
  -  Inability to provide informed consent
  -  Weight over 350 lbs., due to the scanner bore size
  -  Contraindication for MRI study (non-removable metal implants or certain tattoos)

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer

Summary: The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

Detailed description: At study start, only Cohort A is active.
  If, and when, Cohort B and C become active depends on the assessment of benefit and risk observed in the program.
  The sponsor will inform the investigators if, and when, Cohort B and C are active.

Eligibility: Inclusion Criteria:
  -  Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer)
  -  Has received at least 2 prior regimens of standard treatment
  -  Has measurable disease assessed by the investigator based on RECIST version 1.1.
  -  Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
  Exclusion Criteria:
  -  Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
  -  Has a medical history of clinically significant lung disease
  -  Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy

Relevance to patient case: definitely relevant
Patient case: 45-year-old female with colon 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: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Growth Factor Receptor 2) Positive Gastric Cancer After Failure to Standard Care

Summary: BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.


Eligibility: Inclusion Criteria:
  -  Progressive or recurrent HER2/neu positive(IHC 1+≥) gastric cancer
  -  Received 1 or more chemotherapy or radiotherapy as prior therapy for progressive or recurrent tumor lesion
  -  At least 1 measurable lesion according to RECIST(ver 1.1)
  -  Ages above 19
  -  ECOG performance status between 0 to 2
  -  Patients meets the blood test standards in the screening test
  -  Patients meets the blood chemistry test standards in the screening test
  -  Patients who has agreed to a medically accepted contraceptive in this clinical trial
  -  Patients at least six months or more of survival can be expected
  -  Patients decided to participate in this clinical trial and signed written informed consent
  Exclusion Criteria:
  -  Histopathology is a neuroendocrine or small cell carcinoma
  -  History of brain metastasis or signs of brain metastasis
  -  Clinical diagnosis of hepatitis C or hepatitis B
  -  Clinical diagnosis of human immunodeficiency virus (HIV)
  -  History of HIV infection
  -  Patients with heart failure, coronary artery disease(CAD) or Myocardial infarction in 6 month prior to screening. (LVEF is lower than 50% in screening visit)
  -  Administered the drug for other clinical trials within 4weeks before participate in this trial
  -  Administered any vaccines within 4weeks before participate in this trial (4 weeks for live vaccine, 2 weeks for other inactivated vaccine)
  -  Administered the granulocytes concentrates within 3 months before the screening visit
  -  Received chemotherapy or radiation therapy within 2 weeks before the 1st administration of investigational drug(BVAC-B)
  -  Received following formulation within 1 months before the screening visit : Chronic steroids(more than 5 days), immunosuppressant or immunomodulatory agents. G-CSF
  -  Patients who have participated in the clinical trial of a immunotherapeutic vaccine within 1 year or immunotherapy within 3 months before the screening visit
  -  Patients who is pregnant or breast-feeding
  -  Patients who researchers has determined that participation in the clinical trial is inappropriate
  -  Suspected to have other progressive cancer or malignant tumor needs treatment in 3 years. Completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma, cervical intraepithelial neoplasia are not included

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: The ONE-MIND Study: Evaluating the Efficacy of Online Mindfulness-Based Cancer Recovery During Chemotherapy Treatment

Summary: Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue, nausea-vomiting, and sleep problems that can significantly affect patients' quality of life. Fatigue is the most common, lasting and bothersome of these, which prevents people from working and carrying out daily activities. Mindfulness-Based Cancer Recovery (MBCR) is an evidence-based group training program which has shown to help treat negative physical and psychosocial symptoms in cancer patients. The investigators propose to evaluate a pilot-tested online-MBCR program for patients undergoing CT who may be low on energy, time or have compromised immunity.
  Objectives: To evaluate the impact of participation in online MBCR during CT on fatigue (primary outcome), sleep, pain, nausea/vomiting, mood disturbance, stress symptoms and quality of life (secondary outcomes) as well as cognitive function and return to work (exploratory outcomes) over the course of treatment.
  Methods: The study design is a randomized wait-list controlled trial, conducted during CT for patients with breast or colorectal cancer. Participants will take the 12-week online MBCR program at home within 2 weeks of randomization (immediate group) or after CT completion (waitlist group). Outcomes will be assessed online at, 1) Baseline, 2) Post-MBCR, 3) Post-CT (primary outcome) and 4) 12 months post-baseline.
  Anticipated Findings: MBCR is a promising adjuvant program that could help patients prevent, delay or diminish aversive symptoms and side-effects associated with CT, particularly fatigue. If helpful, online-MBCR could be made easily available at cancer centers worldwide and significantly lessen the burden of cancer treatments.


Eligibility: Inclusion Criteria:
  1. Men and women over the age of 18
  2. Diagnosed with either a) stage I-III HER 2 normal breast carcinoma or b) Stage II-III colorectal carcinoma
  3. Scheduled to undergo either neoadjuvant or adjuvant: a) FEC- D or AC-T chemotherapy or b) FOLFOX or CAPEOX chemotherapy
  4. Weekly access to high-speed internet
  5. Access to a computer/tablet/smart phone
  6. Able to attend MBCR classes at scheduled times
  7. Sufficient ability to speak and read English
  8. Willingness to be randomized into immediate or waitlist groups and complete all assessments
  Exclusion Criteria:
  1. Metastatic patients
  2. Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder (self-report)
  3. Currently engaging in meditation one or more times per week within the previous year.
  4. Participation in an MBCR or MBSR program in the last five years.
  5. Cognitive impairment (>6 on the Brief Screen for Cognitive Impairment)
  6. Physical functional impairment that would interfere with the ability to participate in the intervention (on the PAR-Q questionnaire)

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Summary: Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes. This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years of age
  -  Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted)
  -  Stage IV disease
  -  Sufficient FFPE tumour tissue for OCCP testing
  -  Performance status 0-2
  -  Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist
  -  Prognosis > 6 months
  -  Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed
  Exclusion Criteria:
  ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Colonization and Persistence Capacity of a Multi-strain Probiotics in Pediatric Food Allergy to Milk or Egg.

Summary: This study evaluates the addition of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in the treatment of pediatric food allergic children to milk or egg. The allergic participants will receive the probiotics, while other two populations age and sex matched of not confirmed allergic and healthy children will not receive probiotics.

Detailed description: This study evaluates the colonization capacity of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in milk and/or egg allergic children.
  It is expected the recruitment of about 20 egg and/or milk allergic patients aged between 10 and 14 months old confirmed with double-blind oral tolerance test against placebo (Group 1).
  Furthermore, about 10 patients sensible to milk or egg but not confirmed with double-blind oral tolerance test against placebo (Group 2) will be recruited and about 10 healthy individuals (Group 3).
  For all 40 patients:
  1. Baseline presence of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 will be evaluated;
  Only for Group 1 children it will be also evaluate:
  2. The presence of the same strains during 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 and after 60 days from the suspension of the administration.
  Quantification of B. breve, B. longum subsp. longum and B. longum subsp. infantis in faecal samples was carried out by qRT-PCR using the Light Cycler 480 platform (Roche Diagnostics, Mannheim, Germany). The assays were performed with a 20 µl PCR amplification mixture containing: 10 µl LightCycler 480 Probe Master mix (Roche Diagnostics), 2 µl primers and probes (optimized concentrations, 0.5 µM and 0.1 µM, respectively), 3 µl molecular-grade H2O and 5 µl DNA template. Each sample was tested in duplicate to ensure data reproducibility. The RT-PCR temperature profile consisted of an initial denaturation at 95°C for 10 min, 45 amplification cycles at 95°C for 10 sec, 60°C for 30 sec and 72°C for 1 sec followed by a final cooling step at 40°C for 30 sec. Absolute quantification was performed using the "second derivative maximum method"
  Statistical analyses: Wilcoxon signed-rank test was used to compare probiotic species concentrations during the time-course.

Eligibility: Inclusion Criteria:
  - Age between 10 and 14 months
  Exclusion Criteria:
  -  gastrointestinal disease in progress or appearance in the last 30 days
  -  metabolic diseases
  -  antibiotic treatment in the 2 weeks prior to the start of the study;
  -  intake of probiotic, fermented milk or other functional foods in the two weeks preceding the start of the study.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 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: possibly relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 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
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: A Study to Evaluate SHR-1210 in Combination With Capecitabine + Oxaliplatin Sequenced by SHR-1210 + Apatinib as First-line Therapy in Treatment of Advanced Gastric Cancer

Summary: This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 combined with capecitabine and oxaliplatin sequenced by SHR-1210 plus apatinib mesylate versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or mestastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ)
  -  Age ≥ 18 years old, male or female
  -  NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER-2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
  -  Has measurable disease per RECIST 1.1
  -  Eastern Cooperative Group (ECOG) performance status of 0 to 1
  -  Has adequate organ function
  -  Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
  Exclusion Criteria:
  -  Has known HER2-positive status
  -  Has known active central nervous system metastatases
  -  Has received a live vaccine within 4 weeks prior to the first dose of study treatment
  -  With any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
  -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
  -  Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), orventricular arrhythmia which need medical intervention.
  -  Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.

Relevance to patient case: not relevant