araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Targeting the Hippo Transducer TAZ in Breast Cancer With Statins

Summary: This pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer TAZ.


Eligibility: Inclusion:
  -  Signed written informed consent
  -  Female aged >18 years and <75 years at the time of the enrolment
  -  Histologically confirmed Breast Cancer (BC) independently on the intrinsic subtype
  -  Stage I-IIa BC patients candidate for elective surgery
  -  BC expressing Ki-67 ≥ 15% and TAZ > 10% in diagnostic core biopsies
  -  Adequate baseline organ function
  -  Negative pregnancy test
  Exclusion:
  -  Previous systemic therapy including chemotherapy, hormone therapy and targeted agents
  -  Administration of an investigational drug prior to enrolment
  -  History of another malignancy, except for a history of completely resected non-melanoma skin cancer or successfully treated cervical in situ carcinoma
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≥2
  -  Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome and asymptomatic gallstones)
  -  Serious cardiac illness or medical conditions including but not confined to: history of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%); high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately controlled); angina pectoris requiring antianginal medication; clinically significant valvular heart disease; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg)
  -  Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
  -  Current or recent therapy with statins for hypercholesterolemia or other lipid-lowering drugs
  -  Current or recent therapy with glucose-lowering drugs for diabetes
  -  Current or recent therapy with strong CYP3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, itraconazole) given potential interactions with atorvastatin
  -  Current or recent therapy with gemfibrozil or other fibrates given potential interactions with atorvastatin.
  -  Patients who are pregnant or breastfeeding

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Psycho-esthetic Impact of Tattoo Technology as Part of Mammary Reconstruction After Surgery Against Breast Cancer

Summary: Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode.
  The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.

Detailed description: Tattoo is realized as standard car as part of mammary reconstruction after surgery of patient suffering from breast cancer. We try to measured :
  -  Tattooed patient's satisfaction degree with qualitative questionnaire using four level satisfaction scale (very satisfied, satisfied, dissatisfied, very dissatisfied)
  -  Evaluate from patient and jury, the tall, form, color and areola position defects
  -  Evaluate professional jury's satisfaction degree regarding this areola tattoo technology, with the same patient criteria

Eligibility: Inclusion Criteria:
  -  technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer
  Exclusion Criteria:
  -  Two breasts operated patient
  -  surgical reconstruction

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Study Into Treatment of Hyperplasia of Mammary Glands

Summary: Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline for the treatment of this disease. This study was launched to investigate into the problem that which patients should be diagnosed as hyperplasia of mammary glands and which patients should be treated.

Detailed description: Females who meet the inclusion criteria will receive breast ultrasonography, mammography and pathological examinations by core needle biopsy. All participants will receive a follow-up at an 6-month interval for 2 years. During the follow-up period, whether the symptoms relieve will be evaluated.

Eligibility: Inclusion Criteria:
  -  Reported breast pain or breast lumps.
  -  Willing to be kept follow-up.
  -  Functions below are maintained in major organs: liver, renal and heart.
  -  Written informed consent will be obtained for patients for entering this study.
  Exclusion Criteria:
  -  Typical breast cancer or fibroadenoma.
  -  Classification by breast ultrasonography of mammography is beyond Breast Imaging - Reporting And Data System (BI-RADS) 4.
  -  Oral contraceptive or hormone replacement therapy.
  -  History of breast cancer or other malignancies.
  -  History of pituitary gland disease.
  -  Potentially pregnant, pregnant, or breast-feeding.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Breast Cancer

Summary: The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Detailed description: By enrolling patients with breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Eligibility: Inclusion Criteria:
  1. Age:18-80
  2. Karnofsky performance status >60
  3. Diagnosis of breast cancer based on histology or the current accepted radiological measures.
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  5. Will receive interventional therapy
  6. Life expectancy: Greater than 3 months
  7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
  8. Ability to understand the study protocol and a willingness to sign a written informed consent document
  Exclusion Criteria:
  1. Patients with other primary tumor except breast cancer
  2. History of coagulation disorders or anemia

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Study on Breast Cancer Patient Perspectives of Exercise

Summary: The goal of the study is to establish the feasibility/willingness of breast cancer patients to delay surgery to do an exercise program, or be randomized to an exercise training program following treatment, and to see if that willingness correlates with prior physical activity history.


Eligibility: Inclusion Criteria:
  -  women,
  -  breast cancer diagnosis,
  -  all races will be included.
  Exclusion Criteria:
  -  men,
  -  those with no breast cancer (ductal carcinoma in situ),
  -  pregnant women,
  -  children

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Long-term Outcome of HER2-amplified Metastatic Breast Cancer: A Retrospective Analysis

Summary: The aim of this study is to analyze cases of human epidermal growth factor receptor (HER) 2-positive metastatic breast cancer (MBC) of the last 10 years at the University Hospital of Zurich to assess the efficacy of the treatment with trastuzumab in HER2-positive MBC and to find out associations between different variables and the outcome. The aim is to find out probable prognostic factors and patterns of disease progression. Prognostic factors could optimize treatment approaches and result in a delay of disease progression.

Detailed description: Human epidermal growth factor (HER2) is a receptor tyrosine kinase and regulates diverse functions in normal cells such as growth, differentiation and survival of cells. In 25-30 per cent of breast cancer HER2 gene is amplified, what result in abnormally high levels of encoded HER2 protein in malignant cells. Overexpression or amplification of HER2 is associated with an aggressive form of breast cancer seen by significantly shortened disease-free survival and overall survival.
  Trastuzumab, a humanized monoclonal antibody against the extracellular domain of HER2, inhibits the growth of breast tumor cells by receptor internalization, inhibition of cell-cycle progression and recruitment of immune-effector cells. Trastuzumab, as the first anti-HER2 therapy, is approved since 1998 in the United States and since 2000 in European countries for the treatment of HER2-overexpressing metastatic breast cancer (MBC). Single therapy as well as combination with chemotherapy has significantly improved the outcome of these women. Shown by longer time to disease progression, longer duration of response, lower rate of death at 1 year, longer survival and a 20 per cent reduction in the risk of death.
  But still is little known about the long-term outcome nor patterns of disease progression of HER2-positive MBC. A few case reports showed a prolonged complete remission in HER2-positive MBC under an anti-HER2 treatment (trastuzumab, T-DM1, pertuzumab). These cases had some common characteristics such as negative hormone receptor status and metastasis to the live. Another hypothesis is a worse prognosis for patients with early development of CNS metastases.

Eligibility: Inclusion Criteria:
  -  Received at least 1 dose of trastuzumab in metastatic setting at the University hospital of Zurich from 01/2004 to 12/2014.
  -  HER2+ status confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) ≥ 2.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

Summary: This is a phase 1b/2a study investigating the safety and effect of Sym004 in combination with FOLFIRI (chemotherapy) when administered every second week.
  The phase 1b (dose-escalation) portion of the trial is expected to begin Q1 2016. Patients will be sequentially enrolled to dose-escalation cohorts until establishment of the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Sym004 in combination with FOLFIRI.
  The phase 2a (dose-expansion) portion of the trial is expected to begin after establishing the RP2D.


Eligibility: Main inclusion Criteria:
  1. Male or female, at least 18 years of age at the time of informed consent
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  3. Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer (CRC) that is documented to be without Kirsten rat sarcoma (KRAS) or Neuroblastoma rat sarcoma (NRAS) gene mutations (i.e. tumors must express the KRAS and NRAS wild type (WT), exon 2, 3 and 4).
  4. Failed* treatment for locally advanced or metastatic disease with first-line combination therapy of oxaliplatin and a fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after the last dose of first-line therapy and within < 3 months of C1/D1.
  Patients who discontinued first-line therapy due to toxicity may be enrolled provided progression occurred < 6 months after the last dose of the first-line therapy regimen.
  or Failed* adjuvant therapy with combination therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months after the last dose of oxaliplatin and within < 6 months of C1/D1.
  -  Failure is defined as radiologic progression
  5. Eligible for FOLFIRI
  6. Measurable disease according to RECIST v1.1
  Main exclusion Criteria:
  1. Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or irinotecan (CPT-11)
  2. Any antineoplastic agent (standard or investigational) within 4 weeks prior to C1/D1
  3. Significant gastrointestinal abnormalities
  4. Patients with a significant cardiovascular disease or condition
  5. Abnormal hematologic, renal or hepatic function

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples

Summary: A multi-center non-interventional, in-vitro trial for evaluation of concordance of the results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the Immunohistochemical (IHC) method in pathological samples collected from participants with breast cancer.

Detailed description: For accurate selection of participants who will be treated with anti-HER2, primary crucial thing to do is the right identification of HER2 in breast tumor cells. The advantages and disadvantages of IHC and In-Situ Hybridization (ISH) for the detection of HER2 status is still disputable. It is generally agreed on that HER2 study should be applied on all invasive breast cancer participants. It can be used together with IHC which measures HER2 protein expression or ISH which assesses HER2 gene amplification. With regard to IHC, the inconsistency of sensitivity and specificity of marketed antibodies, differences in interpretation and technical artifacts cause problems in diagnosis on occasion. There is not enough study on reasons which cause the consistence and discrepancies between laboratories in HER2 detection with IHC method.

Eligibility: Inclusion Criteria:
  Samples that fulfill all of the criteria will be evaluated for the study.
  -  Samples of women aged greater than or equal to (>/=) 18 and less than (<) 75 years
  -  Tumor samples already diagnosed based on the IHC score of 0 to +3
  -  Samples of primary lesions excluding lymph nodes
  -  10 percent (%) neutral buffered formalin-fixed and paraffin embedded tissue samples
  Exclusion Criteria:
  Samples that fulfill any of the criteria below will not be included in the study.
  -  Non-invasive ductal carcinoma (NOS) samples
  -  Tru-cut biopsies
  -  Non-breast cancer pathological samples

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Walking Affecting Immunology and Quality of Life of Breast Cancer Patients

Summary: Breast cancer is the leading cancer in women worldwide. The incidence of breast cancer is increasing probably due to the prolonged life expectancy and a variety of environmental factors. Fortunately, breast cancer outcome and survival are improving due to early detection and new treatment modalities. After making first strides against breast cancer, i.e. undergoing ablation surgery, most breast cancer survivors still have to go through a series of chemotherapy, which could prolong their survival but almost inevitably downgrade their quality of life due to grueling side effects, such as lack of energy and vulnerability to infection. Numerous medical interventions have been tried by healthcare providers to alleviate these side effects, but some of them are expensive and therefore become another burden for the cancer-afflicted patients. Previous studies have already indicated that exercise generated long-term benefits to breast cancer survivors, including improved physical functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase in both immune function and quality of life. Among a variety of exercises, walking is the least costly, easy-to-follow type. Through a simple, predesigned walking regimen, the investigators expected that the breast cancer patients undergoing chemotherapy could cost-effectively reap some benefit either physically or psychologically.
  Cluster of differentiation 3 (CD3+), presenting at all stages of T-cell development, is a useful maker to identify T-cells. (Cluster of differentiation 4)CD4+ T cells, also known as T helper cells, play an assistant role in the immunologic process, such as maturation of B cells, activations of macrophages or cytotoxic T cells. Cluster of differentiation 8 (CD8+) T cells, known as cytotoxic T cells, responsible for destroying virus-infected cells and tumor cells. Generally, the counts of CD3+ T cells, CD4+ T cells and CD8+ T cells could be a reflection of immune system health. Short-Form 36(SF-36), a patient-reported survey, is a widely adopted tool to evaluate patient's individual health status. By means of serial blood sample collections and the delivery of SF-36 survey, this study aimed to objectively and quantitatively evaluate the effects of aerobic walking on the breast cancer patients undergoing chemotherapy.


Eligibility: Inclusion Criteria:
  1. Stage I-II breast cancer
  2. Have undergone ablative surgery
  3. Going to receive chemotherapy
  Exclusion Criteria:
  -  Difficulty walking

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer

Summary: The purpose of this study is to investigate and analyse genomic profiles in patient with breast cancer who failed standard treatment, refractory and young breast cancer.

Detailed description: The hypothesis is that genomic profiling measured by CancerSCAN, cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be helpful to find out tolerance for chemotherapy and innovate new therapeutic strategies.

Eligibility: Inclusion Criteria:
  1. Histologically or cytologically confirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age).
  2. HER2 positive patient who failed HER2 target therapy including trastuzumab with feasible biopsy site.
  3. Triple Negative Breast Cancer patient who failed standard therapy with feasible biopsy site.
  4. Hormone Receptor positive patient who failed standard therapy with feasible biopsy site.
  5. Age ≥ 21 years
  6. Written informed consent
  Exclusion Criteria:
  1. No feasible biopsy site
  2. No written informed consent

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Optimizing the Delineation of the Tumour Bed in Breast Irradiation

Summary: The aim of the present study is:
  1. to verify whether the delineation of the tumour bed, based on the combination of the visible postoperative changes and the position of the surgical clips on a CT scan in treatment position acquired 1 week before the start of the radiotherapy (RT), provides an accurate localisation of the boost volume compared to the localisation of the tumour on a pre-operative CT-scan.
  2. to document the changes that occur in the tumour bed as seen on a CT scan as a function of the delay between surgery and radiotherapy.
  3. to determine the ideal number and the positioning of the clips needed to reproduce the best treatment volume for the boost.
  4. to propose new guidelines for tumour bed definition and delineation based on the study findings.

Detailed description: Start of the study: february 2012

Eligibility: Inclusion Criteria:
  -  Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy.
  Exclusion Criteria:
  -  Metastases at time of diagnosis

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Women at Risk of Breast Cancer and OLFM4

Summary: Does the olfactomédine provide an help to limit the number of false positives in the overall imaging balance and limit the number of unnecessary biopsies?

Detailed description: About 5% of breast cancers are associated with the presence of a constitutional genetic alteration. Two genes are being studied: BRCA1 and BRCA2.
  The national program for breast cancer screening target women 50 to 74 years but does not include women with significant risk factors. However in identifiable risk situations, breast cancer incidence is increased: and it affects 1 in 4 women with certain risk histological lesions and more than 1 in 2 women carrying a mutation in the BRCA1 or BRCA2 gene.
  Studies have shown that the olfactomédine 4 (OLFM4) is highly overexpressed in tumors compared to healthy tissue. The OLFM4 might therefore be a marker for early detection of breast cancer. We wish to determine the positive predictive value of OLFM4 seric dosing of patients at risk with respect to imaging.

Eligibility: Inclusion Criteria:
  -  Age > or = 18 years
  -  High risk women of breast cancer occurrence defined by the following criteria:
  -  Women carrying a genetic mutation BRCA1 or 2 or TP53, entering or already in screening breast IRM
  -  Women with a high probability of hereditary predisposition to breast cancer (20% risk at 70 years of breast cancer by BOADICEA model), assessed by the onco-geneticists
  -  Information of the person and signing the informed consent
  Exclusion Criteria:
  -  Women with a history of breast cancer or in situ
  -  Person who is not affiliated to a social security scheme or beneficiary of such a regime

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Identification and Semi -Quantification of ER/PR Proteins Expression

Summary: The purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues.
  The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples.

Detailed description: The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Eligibility: Inclusion Criteria:
  -  Women having breast cancer
  Exclusion Criteria:
  -  others

Relevance to patient case: not relevant