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

Clinical trial: Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer

Summary: This study evaluates the genomic profiles of breast cancer in a prospective and population-based manner. In the first phase, breast tumors are analyzed by whole transcriptome RNA-sequencing. Gene expression profiles, mutational profiles, and transcript isoform-level data will be analyzed in the context of patient information, clinicopathological variables, and outcome, with the purpose to develop new molecular diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses will be performed in the future.

Detailed description: Breast cancer exhibits significant molecular, pathological, and clinical heterogeneity. Current patient and clinicopathological evaluation is imperfect for predicting outcome, which results in overtreatment for many patients, and for others, leads to death from recurrent disease. Therefore, additional criteria are needed to better personalize care and maximize treatment effectiveness and survival.
  The Sweden Cancerome Analysis Network - Breast (SCAN-B) study was initiated in 2010 as a multicenter prospective population-based observational study with longsighted aims to analyze breast cancers with next-generation genomic technologies for translational research and integrated with healthcare; decipher fundamental tumor biology from these analyses; utilize genomic data to develop and validate new clinically-actionable biomarker assays; and establish real-time clinical implementation of molecular diagnostic, prognostic, and predictive tests. In the first phase, we focus on molecular profiling by next-generation RNA-sequencing. Gene expression profiles, mutational profiles, and transcript isoform-level data will be analyzed in the context of patient information, clinicopathological variables, and outcome, with the purpose to develop new molecular diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses will be performed in the future.
  As of January 2016, over 8000 patients have enrolled in the study, representing approximately 85% of all eligible patients within the catchment region. Tissue and blood collection is integrated within healthcare routines and clinical information is provided from national quality registries.

Eligibility: Inclusion Criteria:
  -  suspicion or confirmed diagnosis of primary breast cancer
  -  signed informed consent
  Exclusion Criteria:
  -  lack of signed 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: BRCA1 and BRCA2 Mutation in Romanian Population: a Study of Genotype - Phenotype Correlation at Diagnosis With Prospective Disease Outcome and Survival

Summary: Primary objective To determine BRCA1 and BRCA2 variants in 250 Romanian women with breast/ovarian cancer selected for likeliness to harbor germline mutations in these genes by specific criteria for high-risk status including age at disease onset.
  Secondary objective Considering the fact that BRCA testing is not a routine procedure in Romania and mutation prevalence varies in different populations, we intend to look for the founder mutation in our population, running full BRCA genes sequencing to a representative population sample. This would allow a more targeted approach to real-life practice and would ensure personalized solutions for every patient in need.


Eligibility: Inclusion Criteria:
  Categories of patients to be recruited for complete sequencing of all BRCA1 and BRCA2 exons are subjects who have been diagnosed with breast or ovarion cancer and who are:
  1)40 years of age or younger 2)Triple negative breast cancer diagnosed before 50 years of age 3)Male with breast cancer 4)Bilateral breast cancer, first tumor diagnosed before 50 years of age 5)2) + 50 years of age or younger with at least one (first degree) relative diagnosed with breast cancer at 50 years of age or younger or a first degree relative with ovarian cancer 6)of any age with 2 or more relatives with breast cancer 7)of any age with 2 or more relatives with ovarian cancer 8)of any age with a personal history of ovarian cancer, tuba or peritoneal carcinoma 9)Two patients in same branch of the family, Prostate ca < 60 yr and 1st degree relative with BC < 50 yr 10)Two or more 1st and 2nd degree relatives of a patient with breast cancer, at least one of them <50 yr 11)of any age with a family history of male breast cancer or are at increased risk of having a BRCA mutation based on BRCAPRO or Tyrer-Cuzick models
  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: Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR

Summary: The study will shed additional light on the impact of Vectibix® under the current, standard clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the outcomes of Vectibix® treatment in real-life setting.

Detailed description: This is a single-arm, multi-center, prospective, observational, descriptive, noninterventional study in patients with mCRC in Greece who receive Vectibix®in 1st or 2nd line according to approved indication. The aim of the study is to obtain a clear understanding of the current practices concerning real-life treatment of mCRC patients with Vectibix® in first-line in combination with chemotherapy or second-line in combination with chemotherapy in Greece. This setting will also provide the opportunity to observe in a non-selected patient population with RAS WT mCRC the real-life habits of mCRC treatment, and in particular the duration and the outcomes of Vectibix® treatment. The data generated by this study may be used for reimbursement purposes, as it becomes an increasingly common need in Greece to provide locally generated data for use of drugs in the real-life setting to regulatory agencies and/or payors. Furthermore, this study could address the existing data gap in the treatment of anti-EGFR therapy beyond progression in the real-life setting.
  Primary Objective(s): To describe the pattern of use of Vectibix® in combination with chemotherapy in 1st line or in 2nd line mCRC treatments as per approved Vectibix® indication.
  Secondary Objective(s): To investigate the rate of objective response (ORR, defined as either a Complete Response or a Partial Response) and the rate of stable disease as best response in 1st line or in 2nd line chemotherapy regimens of mCRC including Vectibix®.

Eligibility: Inclusion Criteria:
  -  Adult patient (age ≥18 years) at enrollment
  -  Histological documentation of mCRC diagnosis
  -  RAS WT tumor documented before study enrolment as per routine laboratory finding
  -  Subjects whose care will be managed primarily by the enrolling physician and/or all records will be available
  -  Measurable disease at baseline (preferably according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) if routinely used)
  -  Currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen, including Vectibix® as per indication
  -  Tumor assessment (i.e. CT/MRI) within 16 weeks prior to first Vectibix® infusion
  -  Signed informed consent
  Exclusion Criteria:
  -  Participation in any interventional clinical study (currently or during the three previous months from enrollment).
  -  Compromised ability to give informed consent (defined per clinical judgment).
  -  Unknown or mutant RAS tumor type

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

Clinical trial: Initial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.

Summary: Mammography remains an imperfect screening test especially in women with extremely dense breast tissue, missing biologically aggressive cancers especially in younger population and picking up indolent cancers that do not need treatment.
  The most sensitive test for breast cancer detection at our disposal is magnetic resonance imaging (MRI). The preliminary study of Dr Kuhl provide strong arguments that Ultra FAST Breast Magnetic Resonance is suitable for breast cancer screening with high sensitivity and specificity values.
  Data clearly demonstrates that FAST breast MRI could be the standard for breast cancer screening: it is safe, does not induce cancers, and can find more cancers than mammography.
  However this study was performed in women with low to moderately increased risk.The value of FAST Breast Magnetic Resonance in normal screening population has to be assessed before a modification of current strategy of breast cancer screening with mammography.


Eligibility: Inclusion Criteria:
  -  Women referred for routine breast cancer screening
  Exclusion Criteria:
  -  Disabled women (eg, unable to stand)
  -  Pregnant women
  -  Allergy to Gadolinium

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

Clinical trial: SentiMag® Intraoperative Comparison in Breast Cancer

Summary: The purpose of this pivotal study is to provide prospective evidence that the SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB) procedure and to summarize measures of product safety and performance.

Detailed description: This is a pivotal, prospective, open label, multicenter, paired comparison of the SentiMag® and SiennaXP® magnetic sentinel node localization system with the standard of care (radioisotope with blue dye) for lymph node localization in the detection of lymph nodes in patients with breast cancer undergoing a sentinel lymph node biopsy. The trial is designed to provide powered evidence that the lymph node detection rate of the SentiMag® and SiennaXP® system is non-inferior to the standard of care in patients with breast cancer.

Eligibility: Inclusion Criteria:
  -  Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).
  -  Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.
  -  Subjects aged 18 years or more at the time of consent.
  -  Subjects with an ECOG (Eastern Cooperative Oncology Group) performance status of Grade 0 - 2.
  -  Subject has a clinical negative node status (i.e. T0-3, N0, M0).
  Exclusion Criteria:
  -  The subject is pregnant or lactating.
  -  The subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.
  -  The subject has a known hypersensitivity to Isosulfan Blue Dye.
  -  The subject has participated in another investigational drug study within 30 days of scheduled surgery.
  -  Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.
  -  Subject has had preoperative radiation therapy to the affected breast or axilla.
  -  Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.
  -  Subject has intolerance or hypersensitivity to iron or dextran compounds or to SiennaXP.
  -  Subject has an iron overload disease.
  -  Subject has pacemaker or other implantable device in the chest wall.

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

Clinical trial: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Summary: Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.
  Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.
  Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility: Inclusion Criteria:
  -  Age > 19
  -  Written informed consent
  -  ECOG 0-2,
  -  Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
  -  Adequate organ function
  Exclusion Criteria:
  -  Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
  -  Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
  -  Prolonged QT interval in ECG (QTc >450 msec)
  -  Pregnant, lactating women
  -  Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

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

Clinical trial: A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer

Summary: Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.

Detailed description: Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.

Eligibility: Inclusion Criteria:
  -  Metastatic breast cancer
  -  Eastern Cooperative Oncology Group (ECOG) 0 or 1
  -  HER2-expressing primary or metastatic tumor
  -  Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.
  -  Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  -  Normal organ function, including bone marrow function, renal function, liver function, and cardiac function
  -  Signed and dated an informed consent form
  -  Life expectancy of at least 12 weeks
  Exclusion Criteria:
  -  Pregnant or breast feeding
  -  left ventricular ejection fraction (LVEF) < 45% by echocardiogram
  -  Disease-free interval (DFI) less than 12 months
  -  Uncontrolled medical problems
  -  Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin
  -  Patients were unable or unwilling to comply with program requirements

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

Clinical trial: An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus. mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer.

Summary: The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus. mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Detailed description: The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus. mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer..
  Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + + mFOLFOX (PARADIGM Study) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.

Eligibility: Inclusion Criteria:
  (1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study
  Exclusion Criteria:
  (1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study

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

Clinical trial: A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

Summary: This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).
  Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working.
  Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working.
  Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy
  -  Prior 5-FU, oxaliplatin and irinotecan
  -  ECOG Performance Status of 0 or 1
  -  Able to swallow/retain oral drugs
  -  Able and agree to have provide tumor tissue/have biopsies
  -  Agree to use contraception
  -  Not pregnant
  -  Adequate organ system function
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies <28 days or 5 half lives
  -  Prior EGFR, MEK, or RAF inhibitor or regorafenib
  -  Current use of prohibited medications
  -  Unresolved side effects
  -  GI disease or other condition affecting GI absorption
  -  Mucosal or internal bleeding
  -  Any major surgery <four weeks
  -  HIV, HBV, or HCV positive
  -  Active infection
  -  Leptomeningeal disease
  -  Brain metastases
  -  Unacceptable QTcF interval
  -  Significant uncontrolled arrhythmias
  -  Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting < 6 mos.
  -  Class II, III, or IV heart failure
  -  Other clinically significant ECGs
  -  Intra - cardiac defibrillators
  -  Cardiac metastases
  -  Condition that may interfere with patient safety
  -  Hypersensitivity to study drugs
  -  Severe or uncontrolled systemic diseases
  -  Pregnant or lactating
  -  Retinal vein occlusion
  -  Interstitial lung disease or pneumonitis
  -  Active liver or biliary disease

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

Clinical trial: Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)

Summary: National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed colorectal cancer
  2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
  3. Non resectable metastatic disease in a curative intent
  4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment earlier than 6 months ago from inclusion date
  5. Patient presenting with at least one measurable tumour target (greater than 20 mm) according to RECIST criteria, which has never been irradiated
  6. Patient with a greater than 3 month life expectancy
  7. Performance Status less or equal to 2
  8. Male or female 18 years or older
  9. Acceptable blood test
  10. Patient who has signed a written informed consent form
  Exclusion Criteria:
  1. Known and/or symptomatic brain metastases
  2. Known allergy to one of treatment components
  3. Neurological or psychiatric condition which could interfere with good treatment compliance
  4. Patient currently in treatment with any other anti-tumour therapy: chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
  5. Other serious conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrolment/randomisation
  7. Concomitant severe infection.
  8. History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
  9. Patient already included in another clinical trial with an investigational molecule
  10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
  11. Pregnant female, likely to be or currently breast feeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
  12. Those deprived of their freedom or under guardianship
  13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

Relevance to patient case: not relevant