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

Clinical trial: Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib

Summary: The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
  -  Subjects must have:
  1. documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR
  2. a documented T790M EGFR mutation
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1.
  -  Sexually active subjects must use an accepted method of contraception during the course of the study.
  -  Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
  Exclusion Criteria:
  -  Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment.
  -  Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
  -  Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
  -  Receiving anticoagulation therapy with warfarin.
  -  Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
  -  Corrected QT interval (QTc) of >0.45 seconds.
  -  Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases.
  -  Requires steroid or anticonvulsant therapy for the treatment of brain metastases.

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

Clinical trial: A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

Summary: This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility: Inclusion Criteria:
  -  female patients, >=18 years of age;
  -  locally advanced, inflammatory or early stage invasive breast cancer;
  -  HER2 positive (HER2+++ by IHC or FISH/CISH+).
  Exclusion Criteria:
  -  metastatic disease (Stage IV) or bilateral breast cancer;
  -  previous anticancer therapy or radiotherapy for any malignancy;
  -  other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
  -  insulin-dependent diabetes;
  -  clinically relevant cardiovascular disease.

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

Clinical trial: PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

Summary: To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.

Detailed description: The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease.
  This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).

Eligibility: Inclusion Criteria:
  -  Subject was referred for colonoscopy for one of the following reasons:
  -  Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.
  -  Any subject ≥ 18 years of age with:
  -  Positive findings in the colon on a GastroIntestinal (GI) radiographic study
  -  Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
  -  Suspected or known ulcerative colitis
  Exclusion Criteria:
  -  Subject has dysphagia
  -  Subject has congestive heart failure
  -  Subject has renal insufficiency
  -  Subject is known or is suspected to suffer from intestinal obstruction.
  -  Chronic use of laxatives
  -  Subject has a cardiac pacemakers or other implanted electro medical devices.
  -  Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
  -  Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  -  Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
  -  Subject has any condition, which precludes compliance with study and/or device instructions.
  -  Age < 18 years
  -  Subject suffers from life threatening conditions
  -  Subject is currently participating in another clinical study
  -  Subject has known slow gastric emptying time

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

Clinical trial: A Study of ARRY-334543 in Patients With Advanced Cancer

Summary: This is a Phase 1 study during which patients with advanced solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).


Eligibility: Key Inclusion Criteria:
  -  Histological or cytological evidence of malignancy.
  -  Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
  -  Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  -  Additional criteria exist.
  Key Exclusion Criteria:
  -  Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
  -  Use of an investigational medication or device within 30 days prior to first dose of study drug.
  -  Major surgery within 30 days prior to first dose of study drug.
  -  Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
  -  Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
  -  Pregnancy or lactation.
  -  Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C.
  -  Additional criteria exist.

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

Clinical trial: A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer

Summary: This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US and Canada will be enrolled in this study.


Eligibility: Key Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
  -  Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  -  Must be able to take and retain oral medications.
  -  Additional criteria exist.
  Key Exclusion Criteria:
  -  Active concomitant malignancies.
  -  Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
  -  Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  -  Requiring intravenous (IV) alimentation.
  -  Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
  -  Pregnancy or lactation.
  -  Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
  -  Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
  -  History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
  -  Additional criteria exist.

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

Clinical trial: Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


Eligibility: Inclusion Criteria:
  -  Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
  -  Prior use of Herceptin (trastuzumab), and a taxane
  -  Adequate cardiac and renal function
  Exclusion Criteria:
  -  More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
  -  Bone as the only site of disease
  -  Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
  -  Significant gastrointestinal disorder with diarrhea as major symptom

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

Clinical trial: Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

Summary: The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

Detailed description: Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.
  In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.
  The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.

Eligibility: Inclusion Criteria:
  -  Histologically verified adenocarcinoma in colon or rectum with metastatic spread.
  -  No mutations in the KRAS gene.
  -  Resistance to 5-FU, oxaliplatin and irinotecan.
  -  Age ≥18 years.
  -  PS 0-2.
  -  Measurable disease according to RECIST criteria.
  -  Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
  -  Oral and written informed consent.
  Exclusion Criteria:
  -  Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
  -  Verified or clinically suspected CNS metastasis.
  -  Other experimental treatment.
  -  Serious medical disease according to investigator's judgement.
  -  Pregnant or breastfeeding women.
  -  Hypersensitivity to the active substance or to one or more of the auxiliary substances.
  -  Patients with interstitial pneumonitis or pulmonary fibrosis.

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

Clinical trial: Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

Summary: This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.

Detailed description: This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. Even if the safety profile of the combination of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver events including 14% of severe liver events.

Eligibility: Inclusion Criteria:
  -  Woman aged 18 years or older.
  -  Confirmed pathologic diagnosis of breast cancer.
  -  Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
  -  Surgically sterile or postmenopausal woman.
  -  Documented ER+ and/or PgR+ and erbB2- tumor.
  -  Progression of locally advanced or metastatic disease during treatment with a nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant nonsteroidal AI.
  Exclusion Criteria:
  -  Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
  -  More than 1 prior endocrine treatment for locally advanced or MBC.
  -  More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
  -  Bone or skin as the only site of disease.

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

Clinical trial: Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

Summary: This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.


Eligibility: Inclusion Criteria:
  -  Advanced adenocarcinoma of lung, measurable disease
  -  Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
  -  patients with known EGFR activating mutation regardless of smoking status
  -  ECOG(Eastern Cooperative Oncology Group) 0-1.
  Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy
  Exclusion Criteria:
  -  Active brain metastases
  -  Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
  -  known EGFR wild type NSCLC

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

Clinical trial: Level of HER2-neu Gene Amplification an Response to Trastuzumab

Summary: Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility: Inclusion Criteria:
  -  HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
  Exclusion Criteria:
  -  HER2-negative advanced breast cancer Pretreatment with trastuzumab

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

Clinical trial: Lapatinib Resistance in Patients With Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.
  PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.

Detailed description: OBJECTIVES:
  -  To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
  -  To investigate ErbB2 copy number changes and expression levels.
  -  To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.
  OUTLINE: Previously collected tumor tissue samples* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.
  NOTE: *Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.

Eligibility: DISEASE CHARACTERISTICS:
  -  Pathologically confirmed invasive breast cancer
  -  ErbB2-positive disease
  -  Has received or is currently receiving lapatinib ditosylate
  -  Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)
  -  Must have tumor tissue samples available for research studies
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Not pregnant*
  -  Coagulation profile normal*
  -  Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Concurrent chemotherapy or trastuzumab (Herceptin®) allowed
  -  No concurrent anticoagulants, including warfarin or low-molecular weight heparin*
  -  No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy

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

Clinical trial: Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer

Summary: RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread.
  PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To assess frequency of circulating tumor cells (CTCs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers.
  -  To assess the variability in number of CTCs between patients with the same tumor type.
  -  To correlate the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers.
  OUTLINE: Blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. Samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., EGFR, phosphorylated EGFR, AKT, phosphorylated AKT, cytokeratins, MAPK, Src, and FAK).

Eligibility: DISEASE CHARACTERISTICS:
  -  Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  No history of any prior cancer
  PRIOR CONCURRENT THERAPY:
  -  No prior therapy for metastatic disease

Relevance to patient case: not relevant