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

Clinical trial: A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

Summary: The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery
  -  BRAF or NRAS mutation in tumor tissue
  -  All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol
  -  Evidence of measurable tumor disease as per RECIST
  -  WHO performance status of 0-2
  -  Adequate organ function and laboratory parameters
  Exclusion Criteria:
  -  History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO
  -  Patients with unstable CNS metastasis
  -  Prior treatment with a MEK- inhibitor
  -  Impaired cardiovascular function
  -  HIV, active Hepatitis B, and/or active Hepatitis C infection
  -  Pregnant or nursing (lactating) women
  -  Women of child-bearing potential UNLESS they comply with protocol contraceptive requirements
  Other protocol-defined inclusion/exclusion criteria may apply.

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

Clinical trial: Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer

Summary: Women with metastatic breast cancer, receiving first line treatment of any kind (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this trial. In connection to treatment, blood samples for determination and enumeration of circulating tumour cells will be collected at different time points. Serum and plasma will be collected and stored for future analysis of RNA and DNA.


Eligibility: Inclusion Criteria:
  -  Women with metastatic breast cancer
  -  ECOG performance status 0-2
  -  Age over18 years
  -  Signed informed concent
  -  Predicted life expectancy over 2 months
  -  Planned for first line systemic treatment for metastatic disease (chemotherapy, antibody treatment or endocrine treatment)
  -  Standard imaging evaluation within 4 weeks of inclusion
  -  Planned for standard imaging within 16 weeks after start of therapy
  Exclusion Criteria:
  -  Prior medical therapy for metastatic disease (prior adjuvant chemotherapy, radiotherapy or endocrine therapy is permitted)
  -  Inability to understand information about the study
  -  Other malignant disease with the exception of curatively treated basal cell or squamous cell cancer of the skin and cancer in situ of the cervix

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, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.
  Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  histologically/cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus - Unacceptable ocular/retinal conditions
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Tumour Registry Breast Cancer

Summary: The registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice of office-based and clinic-based medical oncologists in Germany.

Detailed description: The TMK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
  The impact of nutrition (MaNut) and physical activity (MaNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (MaTox) and the multiple patient-reported outcomes (MaLife).

Eligibility: Inclusion Criteria:
  -  Breast cancer
  -  18 years and older
  -  Antineoplastic or antihormonal treatment
  Exclusion Criteria:
  -  No breast cancer
  -  Below 18 years
  -  No antineoplastic or antihormonal treatment

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, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.
  Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  Histologically/ cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement.
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions

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

Clinical trial: Proton Therapy for Lymph Nodes in Breast Cancer

Summary: The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion.
  -  Patients must have undergone either mastectomy or breast conservation surgery.
  -  Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative.
  -  Patient must require peripheral lymph node radiation per physician discretion.
  Exclusion Criteria:
  -  Evidence of distant metastasis (M1).
  -  Prior radiotherapy to the area of interest.
  -  Prior history of cardiovascular disease per physician discretion.
  -  Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years.
  -  Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.

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

Clinical trial: The Jewels in Our Genes Study - an African American Family Study of Breast Cancer

Summary: The research team is studying why some African American families have multiple cases of breast cancer.
  This study will help to better understand if there are undiscovered genes unique to African Americans that may predict early breast cancer risk.
  Breast cancer survivors AND their relatives who are also breast cancer survivors are being recruited to the study.


Eligibility: Inclusion Criteria:
  -  Black/African American
  -  Ever diagnosed with breast cancer
  -  Have at least one living blood relative ever diagnosed with breast cancer, who is also willing to participate
  -  Live in the U.S.
  Exclusion Criteria:
  -  Tested positive for BRCA mutations

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 Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

Summary: To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

Detailed description: 1. Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
  2. All the patients enrolled will be given standard cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK, followed by low-dose Oral Cyclophosphamide .
  3. The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
  4. Estimate time to progression, survival rates and clinical benefit response on patients.
  5. Find biomarkers associated with drug response.

Eligibility: Inclusion Criteria:
  -  Failure to anthracycline and/or taxol chemotherapy;
  -  metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
  -  Metastatic tumor can not be removed through surgery procedure;
  -  An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  -  Normal cardiac, hepatic, renal and bone marrow functions;
  -  Life expectancy ≥3 months.
  Exclusion Criteria:
  -  Central nervous system metastases;
  -  Serious or uncontrolled concurrent medical illness;
  -  History of other malignancies;
  -  Having been enrolled in some other clinal trials within a month;

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

Clinical trial: Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

Summary: The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Diagnosis of metastatic colorectal cancer (CRC)
  -  Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  -  At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
  -  Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.
  -  Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
  -  Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
  -  Man or woman at least 18 years of age
  -  Adequate hematologic, renal, hepatic and metabolic function
  -  Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
  -  Subject or subject's legally acceptable representative has provided informed consent.
  -  Other protocol-specified criteria may apply
  Exclusion Criteria:
  -  Symptomatic brain metastases requiring treatment
  -  History of another primary cancer within 5 years of randomization
  -  Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib)
  -  Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization
  -  Radiotherapy within 14 days before randomization.
  -  Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study: Prolongation of QT/QTc interval > 450 milliseconds at screening
  -  Other protocol-specified criteria may apply

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

Clinical trial: High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents

Summary: High sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR mutations) together with addiction to the given target. More recently, activation of "alternative pathways" (Kras mutation, PI3K mutations) have been reported as a common resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).
  From these data has emerged the hypothesis that identification of the deregulated pathway through new molecular tools could allow to propose a more tailored targeted regimen.
  Based on these concepts, numbers of phase I/II trials enrich their populations in patients presenting specific molecular alterations.
  High throughput technologies (array CGH, sequencing, gene expression array) identify deregulated genes. In addition, these technologies determine whether such genomic alterations are single (expected efficacy of single agent) or multiple (rationale for combination). In a pilot study that included 135 patients, we recently performed a combination of array CGH and hot spot mutation array in order to drive patients into phase I/II clinical trials. This study led to the conclusions that high throughput technologies i. are feasible (80%) and robust, ii. identify "targetable" genomic alterations in around 40% of samples.
  In the present study, the investigators will perform high throughput technologies to drive 400 metastatic breast cancer patients into specific phase I/II trials.


Eligibility: Inclusion Criteria:
  -  Men and Women with histologically diagnosed breast cancer
  -  Metastatic relapse or stage IV breast cancer at diagnosis
  -  Metastases amenable to biopsy
  -  Age <70 years old
  -  PS 0/1
  -  No restriction regarding the number of previous chemotherapy or endocrine therapies
  Exclusion Criteria:
  -  Age <18
  -  Life expectancy <3 months
  -  Symptomatic or progressing brain metastases
  -  Progressive patients at the time of biopsy
  -  LVEF <50% (MUGA or ultrasonography)
  -  Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  -  Absolute neutrophil count < 1.5 x 109/L
  -  Platelet count < 100 x 109/L
  -  Haemoglobin < 90 g/L
  -  ASAT/ALAT > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
  -  Total bilirubin > 1.5 times ULN
  -  Creatinine >1.5 times ULN
  -  Corrected calcium > ULN
  -  Phosphate > ULN
  -  Abnormal blood coagulation that contra-indicates biopsy
  -  Patients deprived of liberty or placed under the authority of a tutor

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 Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

Summary: To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer patients.

Detailed description: This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.

Eligibility: Inclusion Criteria:
  -  Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group 1) or invasive triple-negative breast cancer (Group 2)
  -  Free of metastatic disease
  -  ≥ 18 years old
  -  Female
  -  Had no prior treatment for any cancer
  -  Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide
  Exclusion Criteria:
  -  Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
  -  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: Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

Summary: This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H&E and unstained slides to specific biomarker results using immunohistochemistry.

Detailed description: This protocol requires the collection of blood (5 ml), fine-needle aspirate biopsies (FNAB), and post-surgical thyroid cancer tissue. The post surgical tissue includes fresh-frozen tissue that is considered waste and in excess of that required for pathologic diagnosis, and archived formalin-fixed, paraffin-embedded tissue (FFPE). The blood will be used as a substrate for assessing known markers, including microRNA expression patterns that may be useful to predict disease and thyroid cancer morphotype. The FNABs will be used to screen the potential of markers for pre-operative diagnosis. The post-surgical fresh-frozen thyroid cancer tissue will be used to isolate DNA and RNA in order to assess somatic mutations (RAS and PAX8/PPAR-gamma rearrangement) and messenger RNA, and microRNA expression patterns. The FFPE tissue will be used to obtain H&E and unstained slides to validate results using immunohistochemistry. The goal of these studies is to define molecular markers that will accurately distinguish benign from malignant disease and the multiple thyroid cancer phenotypes. Current methods of distinguishing benign from malignant disease requires a detailed post-surgical analysis and no known markers have yet been identified to reliably differentiate the multiple thyroid cancer morphotypes.

Eligibility: Inclusion Criteria:
  -  Patient with palpable thyroid nodule suspicious for thyroid neoplasm
  -  Patient selected to undergo fine needle biopsy for cytologic diagnosis
  -  Male (18 years of age or older)
  -  Female (18 years of age or older)

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 Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

Summary: This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.


Eligibility: Inclusion Criteria:
  -  Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS
  -  Measurable disease as determined by RECIST 1.1
  Exclusion Criteria:
  -  Primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions
  -  Clinically significant cardiac disease or impaired cardiac 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: Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast Cancer

Summary: To determine the overall objective response rate of pegylated liposomal doxorubicin （Lipo-Dox）combined with cyclophosphamide/5-FU as second-line treatment in patients with metastatic breast cancer.


Eligibility: Inclusion Criteria:
  -  histologically proved breast cancer with metastatic disease
  Exclusion Criteria:
  -  life expectancy less than 3 months.

Relevance to patient case: not relevant