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

Clinical trial: T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

Detailed description: OBJECTIVES:
  -  Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.
  OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.
  Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of solid epithelial tumor, including, but not limited to, the following:
  -  Breast cancer
  -  Ovarian cancer
  -  Lung cancer
  -  Uterine cancer
  -  Prostate cancer
  -  HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
  -  Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)
  PATIENT CHARACTERISTICS:
  -  Absolute neutrophil count > 1,000/mm^3
  -  Absolute lymphocyte count > 400/mm^3
  -  Platelet count > 90,000/mm^3
  -  Hemoglobin > 8 g/dL
  PRIOR CONCURRENT THERAPY:
  -  No other chemotherapy within the past 4 weeks

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

Clinical trial: Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

Summary: The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time.
  The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours Post-Dose.


Eligibility: Inclusion Criteria:
  -  Has at least 1 year history of migraine (with or without aura)
  -  Females of child bearing potential must use acceptable contraception throughout trial.
  Exclusion Criteria:
  -  Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
  -  Has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
  -  Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  -  Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
  -  Has a history of cancer within the last 5 years.

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

Clinical trial: Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)

Summary: The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.


Eligibility: Inclusion Criteria:
  -  At least 1 year history of migraine (with or without aura)
  -  Females of child bearing potential must use acceptable contraception throughout trial
  -  In general good health based on screening assessment
  Exclusion Criteria:
  -  Pregnant/breast-feeding (or is a female expecting to conceive during study period)
  -  History or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
  -  Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  -  History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
  -  History of cancer within the last 5 years

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

Clinical trial: Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

Summary: RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.
  PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

Detailed description: OBJECTIVES:
  -  Characterize each woman's individual mammographic density (MD) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual MD longitudinal change and breast cancer risk.
  -  Examine whether these patients or healthy participants manifest different patterns of within-individual change in MD and evaluate predictors of across-individual differences.
  -  Determine whether the developmental profile of MD differs systematically between these patients and healthy participants.
  OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity.
  -  Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
  -  Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
  PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system
  -  Have at least 3 screening mammograms since 1994
  -  for cases, diagnosis with breast cancer between 2004-2006
  Exclusion criteria:
  -  having had irregular screening (less than 3 mammorgrams since 1994)
  -  Having breast implants
  -  Known carriers of BRCA1/BRCA2 genes
  -  Unable to give written consent

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

Clinical trial: A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

Summary: BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinical data suggest that it is tolerable in patients with metastatic breast cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced metastatic breast cancer.


Eligibility: Key Inclusion Criteria:
  -  Women 18 years or older
  -  Histologically confirmed breast cancer
  -  Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)
  -  Availability of estrogen and progesterone receptor status
  -  At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy
  -  For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer
  -  Life expectancy ≥ 12 weeks
  -  Eastern Cooperative Oncology Group performance status ≤2
  -  Women of child bearing potential must agree to 2 forms of contraception during the course of the trial.
  Key Exclusion Criteria:
  -  Inability to understand/unwillingness to sign a written informed consent
  -  Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
  -  Currently using an investigational agent
  -  Clinically significant gastrointestinal abnormalities
  -  Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication
  -  Concurrent palliative radiation or anti-cancer treatment
  -  Women who report pregnancy, are breast-feeding or have a positive pregnancy test

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

Clinical trial: Local Surgery for Metastatic Breast Cancer

Summary: Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival

Detailed description: This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.
  In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.

Eligibility: Inclusion Criteria:
  -  Women with metastatic breast cancer at the initial diagnosis
  Exclusion Criteria:
  -  Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
  -  who have systemic morbidity that do not allows her to be in the trial,
  -  who have synchronous breast cancer at the contralateral breast,
  -  who have a previous cancer history or another primary cancer history and metastasis at the past,
  -  who have palpable lymph node/nodes at the contralateral axilla,
  -  who do not agree to participate the trial

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

Clinical trial: Molecular Analysis of Breast Cancer

Summary: This is a research-based study that is looking at the biologic features of breast tissue, lymph node tissue, or blood in order to study breast cancer development growth, and spread. Through tissue and/or blood samples we hope to gain further knowledge and understanding of how to improve diagnosis and treatment of breast cancer by identifying the molecular markers that predict clinical outcome and response to therapy.

Detailed description: The tissue obtained in this protocol will be used for genome-wide examination of DNA, RNA expression profiling, proteomic analyses, isolation and analyses of normal and cancer stem cells, isolation and analyses of circulating tumor cells, possible analyses of immune cells, and possible analyses of serum factors. The tissue may also be used to develop patient-specific cell culture models or mouse xenograft models of breast cancer for biologic study of tumor progression and metastases and for therapeutic testing. In general, the tissue will be used in studies that will molecularly classify tumors, identify prognostic markers, identify potential therapeutic markers, identify potential treatment targets, and help us better understand the biology and specific role played by different tumor cells in the metastatic process.
  The ultimate goal is to use molecular analyses to improve the diagnosis and treatment of breast cancer.

Eligibility: Inclusion Criteria:People eligible for this study include anyone older than 18 years who is undergoing one of the following procedures: core needle or surgical breast biopsy, lumpectomy, mastectomy, axillary lymph node surgery, breast reduction surgery, or ductal lavage or ductoscopy. Patients who have had breast cancer in the past who are currently free of disease or who have a breast cancer recurrence are also eligible. All patients who participate must be able to understand and sign the informed consent. Although most patients will be female, any males undergoing the above procedures are also eligible for this study.
  Exclusion Criteria:Any patient who is less than 18 years old, who is unable to understand the informed consent, or not undergoing the above procedures will be excluded from this research.

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

Clinical trial: Anonymous Testing of Pathology Specimens for BRCA Mutations in Ashkenazi Jewish Individuals Who Have Cancer

Summary: The intent of the proposed study is to describe the prevalence of the most common recurring mutations in BRCA1 and BRCA2, blmAsh , and the A636P MSH2 mutation among Ashkenazi Jewish individuals with a variety of cancer diagnoses. If a substantial proportion of these samples contain such mutations, future patients presenting with these diseases may wish to undergo genetic counseling and, if appropriate, formal genetic testing. The benefit from such a process would pertain mainly to the families of these individuals.

Detailed description: Germline mutations in the genes BRCA1 and BRCA2 have been demonstrated in the majority of hereditary breast and ovarian cancer families. The increased risk to develop both breast and ovarian cancer associated with inheriting a BRCA1 or BRCA2 mutation has been well established. It has also been suggested that is an overrepresentation of other cancers such as colon, prostate and pancreatic cancer present in BRCA1 or BRCA2 families. Population specific mutations in BRCA1 and BRCA2 have been identified. In the Ashkenazi Jewish population, 3 specific mutations have been seen in 2% of the population. This study will anonymously screen archived tissue samples of Ashkenazi Jewish individuals diagnosed with cancer between 1993 and 1996 at MSKCC for the three founder mutations seen in the Ashkenazi Jewish population. Results will be stratified by tumor type and compared with the population frequency to determine whether individuals inheriting mutations in BRCA1 or BRCA2 may have an increased risk to develop other cancers, in addition to breast and ovarian cancer. This information will be useful in helping to identify individuals who may benefit from genetic counseling and possibly genetic testing who to date are not typically referred. It will also be useful in developing high-risk cancer screening strategies and determining appropriate options for prophylactic surgery.

Eligibility: Inclusion Criteria:
  -  Diagnosis of cancer made at MSKCC or collaborating institutions, AND
  -  Tissue block of tumor or normal margin or extracted DNA available for study and sufficient material present to allow study without exhausting block or DNA,
  -  Individual self-identified as Jewish on intake.

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

Clinical trial: Proton Therapy for Early Stage Breast Cancer

Summary: The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

Detailed description: Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.

Eligibility: Inclusion Criteria:
  -  Invasive ductal, medullary, papillary, colloid or tubular histologies
  -  Stages T1 or T2 (tumors < or = 3 cm) from lumpectomy specimen.
  -  No more then 3 positive nodes on axillary dissection or negative sentinel node.
  -  Negative surgical margins (>2mm)
  Exclusion Criteria:
  -  Invasive lobular histology
  -  Previous chemotherapy for breast cancer
  -  Extensive intraductal component
  -  Collagen vascular disease
  -  Prior malignancy unless disease-free for 5 years
  -  Patients who are pregnant or lactating

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

Clinical trial: Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

Summary: To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.


Eligibility: Inclusion Criteria:
  -  Must be female and greater than or equal to 18 yrs of age
  -  Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
  -  Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
  -  Participants may have received prior hormone therapy for locally recurrent or metastatic disease
  Exclusion Criteria:
  -  Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification
  -  Prior chemotherapy or targeted therapy for metastatic breast cancer
  -  Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
  -  History of, or active brain mets
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
  -  Prior history of high blood pressure crisis
  -  Have a serious, nonhealing wound, ulcer, or bone fracture

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

Clinical trial: Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Summary: The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.


Eligibility: Inclusion Criteria:
  -  Females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
  -  Radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as radiation or surgery
  -  Positive status for human epidermal growth factor receptor 2
  -  Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines
  -  Karnofsky performance status of 70 to 100
  -  Life expectancy of at least 3 months
  Exclusion Criteria:
  -  Prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
  -  Common Terminology Criteria Grade 2 or greater neuropathy
  -  Inadequate hematologic, hepatic, or renal function
  -  Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or known hypersensitivity or prior intolerance to fluoropyrimidine
  -  Known or suspected dihydropyrimidine dehydrogenase deficiency
  -  More than 3 prior chemotherapy regimens in the metastatic setting
  -  Prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months

Relevance to patient case: not relevant