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

Clinical trial: Assessment of Candidate Protein Expression in Breast Cancer Specimens

Summary: RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
  PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.

Detailed description: OBJECTIVES:
  -  To determine if candidate genes display differential expression between normal and cancer breast tissues.
  OUTLINE: Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of breast cancer
  -  Tissue samples available
  -  Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories:
  -  Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative
  -  ER-positive/PR-positive/ HER2-positive by FISH
  -  ER-negative/PR-negative/HER2-positive
  -  ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers)
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Metformin Pre-Surgical Pilot Study

Summary: The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.

Detailed description: The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a biguanide derivative which is commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin on a specific molecular pathway called the AMPK/mTOR signaling pathway in the tumor. The effects of metformin on serum insulin levels and components of the insulin resistance syndrome will also be studied.

Eligibility: Inclusion Criteria:
  -  Histologically-confirmed operable invasive breast cancer or DCIS who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
  -  Body mass index > 25
  -  Age ≥ 21 years
  -  No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
  -  Signed informed consent
  Exclusion Criteria:
  -  History of diabetes mellitus requiring medical therapy
  -  Treatment with other investigational drugs within 6 months of study entry
  -  Significant renal impairment with a creatinine > 1.4 mg/dl
  -  Other serious intercurrent medical illness

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

Clinical trial: Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

Summary: This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

Detailed description: PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.
  OUTLINE: This is a phase I study followed by a randomized phase II study.
  PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.
  RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
  After completion of study treatment, patients are followed up periodically.

Eligibility: Inclusion Criteria:
  - Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer
  Exclusion Criteria:
  -  Prior lymphedema in either arm
  -  Prior history of axillary surgery (except for sentinel node biopsies)
  -  Prior history of chest/axillary radiation
  -  Need for bilateral axillary node dissection surgery
  -  Prior neurologic deficits (either motor or sensory) in ipsilateral arm
  -  Known allergy to vital blue dyes
  -  No prior diagnosis of inflammatory breast cancer
  -  Cannot be pregnant or planning to continue breast-feeding immediately after surgery

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 Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen

Summary: This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II.


Eligibility: Inclusion Criteria:
  -  Histologically documented, incurable, locally advanced or metastatic breast cancer
  -  Evaluable or measurable HER2-positive disease
  -  History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer
  -  Previous treatment with chemotherapy for MBC
  -  Granulocyte count ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL
  -  Serum bilirubin ≤ 1.5 mg/dL; AST, ALT, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST ≤ 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase ≤ 5 × ULN
  -  Serum creatinine ≤ 1.5 mg/dL or creatinine clearance of ≥ 60 mL/min based on a 24-hour urine collection
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  -  Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment
  Exclusion Criteria:
  -  History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication
  -  History of Grade ≥ 3 hypersensitivity reaction to trastuzumab
  -  History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued
  -  Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment
  -  Require supplemental oxygen for daily activities
  -  Grade ≥ 2 peripheral neuropathy
  -  Bisphosphonate therapy for symptomatic hypercalcemia
  -  Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment
  -  Any experimental therapy within 4 weeks of first study treatment
  -  Any major surgical procedure within 4 weeks of first study treatment
  -  History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis
  -  Pregnancy or lactation
  -  Cardiac troponin I ≥ 0.2 ng/mL
  -  Ejection fraction < 50% or below the lower limit of normal determined by echocardiogram or MUGA scan
  -  Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent

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

Clinical trial: Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

Summary: The purpose of this study is to study patients presenting with stage IV breast cancer. Stage IV means that the breast cancer has spread to another part of the body outside the breast. This study is important because in different parts of the country some patients are being offered surgical treatment for the breast tumor and some are not. The doctors do not know if surgery for the breast tumor is helpful in patients with stage IV breast cancer. The doctors will collect information about the patient and their treatment to learn more about how patients and doctors make treatment decisions. The doctor will also collect blood samples and tissue samples for laboratory studies to learn more about tumors that have spread to other parts of the body.


Eligibility: Inclusion Criteria:
  -  Age 18 years or older
  -  Known or suspected Stage IV breast cancer with intact primary tumor
  -  Known or suspected Stage IV breast cancer with intact primary tumor, having begun systemic therapy within the past 12 months
  -  Known or suspected Stage IV breast cancer within 3 months of local breast surgery
  -  Known or suspected Stage IV breast cancer within 3 months of local breast surgery, having begun systemic therapy within the past 12 months
  Exclusion Criteria:
  -  Primary breast cancer diagnosis made by FNA only and no pre-treatment core biopsy planned for diagnostic or research purposes.
  -  Failure of MSKCC or participating site to confirm Stage IV breast cancer diagnosis by biopsy within 30 days of study enrollment

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 Support Groups for African-American Breast Cancer Survivors

Summary: RATIONALE: A study that evaluates successful Los Angeles-based, peer-led African American breast cancer survivor support groups may help in developing a guide on how to organize and maintain breast cancer support groups.
  PURPOSE: This clinical trial is studying support groups for African-American breast cancer survivors.

Detailed description: OBJECTIVES:
  -  Characterize five established Los Angeles (LA)-based, peer-led African American Breast Cancer Survivor (AABCS) support groups by identifying and evaluating the successful elements of structure and process that distinguish these groups: the purpose and goals; theories and techniques that are utilized; the structure of the group and implementation of specific goals; the cultural aspects that are incorporated to enhance the efficacy; and similarities and differences among these AABCS support groups.
  -  Develop a preliminary "Culturally Informed Breast Cancer Support Group Guide" on how to organize and maintain support groups, modeled on the "best model" experiences of the five established LA-based support groups for AABCS.
  -  Conduct three needs-assessment focus groups and 5 key informant interviews in the Inland Empire to evaluate the psychosocial needs and resources of AABCS in that region.
  OUTLINE: At least 10 support group leaders (2 from each support group) undergo semi-structured interviews to elicit information about the needs of breast cancer survivors in their community and the cultural modes of support that are given. Eight to twelve African American Breast Cancer Survivors (AABCS) participate in 5 focus group discussions and complete a questionnaire about their breast cancer and experience with support groups for qualitative and quantitative analysis.
  At least 5 Inland Empire community leaders undergo semi-structured interviews to elicit information about the needs of breast cancer survivors in their community. Eight to twelve AABCS from the Inland Empire participate in 3 focus group discussions and complete a questionnaire about their breast cancer and experience with support groups for qualitative and quantitative analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  African American Breast Cancer Survivor (AABCS) meeting 1 of the following criteria:
  -  A member of 1 of the 5 support groups listed below
  -  Live in the Inland Empire region of California
  -  A cancer support group leader or facilitator of 1 of the 5 established support groups in Los Angeles:
  -  Women of Essence (WOE)
  -  Women of Color (WOC)
  -  Support Sisters African American Breast Cancer Support Groups
  -  Sisters
  -  Celebrate Life
  -  A community leader knowledgeable about breast cancer support services in the Inland Empire region
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.

Summary: Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®


Eligibility: Inclusion criteria:
  1. Female patients aged >18 years.
  2. Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.
  Exclusion criteria:
  Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this 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: Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer

Summary: The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.


Eligibility: Inclusion Criteria:
  1. Female presenting with metastatic breast cancer.
  2. Tumor must have been tested by FISH/CISH for FGFR1 amplification.
  3. HER2 and HR status must have been determined.
  4. Patients must have HER2 negative breast cancer.
  5. Patients must have a documented disease progression as define by RECIST at baseline.
  6. Patients with HR+ disease:
  -  Must have received at least one prior endocrine therapy in the metastatic setting.
  -  Must have received no more than three lines of chemotherapy in the metastatic setting.
  7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
  Exclusion Criteria:
  1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
  2. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  -  History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
  -  Clinically significant resting bradycardia (< 50 beats per minute).
  -  LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%.
  3. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
  4. Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.
  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: Relationship of pAKT to Survival in Patients With Node-Positive Breast Cancer

Summary: This study will examine the relationship of a protein called pAKT to survival of breast cancer patients with one or more positive axillary lymph nodes. Akt plays a role in cell survival, tumor formation, and the development of drug resistance.
  The study will use tumor tissue obtained from 2,000 patients enrolled in a National Surgical Adjuvant Breast and Bowel Project study that is evaluating whether adding the drug paclitaxel (Taxol (Registered Trademark)) to a treatment regimen of doxorubicin (Adriamycin (Registered Trademark)) and cyclophosphamide (Cytoxan (Registered Trademark)) improves disease-free survival and overall survival in patients with node-positive breast cancer. The current study will measure levels of pAkt in the tissues and correlate the results with clinical outcome to see if pAkt levels are associated with improved patient survival.

Detailed description: Taxanes (paclitaxel and docetaxel) have emerged as the most powerful chemotherapeutics in breast cancer over the past decades. The B-28 clinical trial from the National Surgical Adjuvant Breast and Bowel Project (NSABP) assesses the efficacy of adding paclitaxel to the doxorubicin/cyclophosphamide regimen in the treatment of patients with axillary node positive breast cancer. The primary aim of B-28 is to determine whether four cycles of paclitaxel (Taxol (Registered Trademark)) (T) following four cycles of postoperative Doxorubicin (adriamycin (Registered Trademark) (A) and cyclophosphamide (C) will more effectively prolong disease-free survival (DFS) and survival (S) than four cycles of AC alone in patients with operable breast cancer who have one or more histologically positive axillary lymph nodes. The B-28 clinical trial tissue microarray consists of specimens from 2,000 cases enrolled. The tissue microarray set is an ideal platform for evaluating predictive markers of doxorubicin and/or paclitaxel response or resistance.
  Akt, a serine/threonine protein kinase regulated by the phosphatidylinositol 3-kinase (PI3K), is of importance in cell survival, tumorigenesis, and recently shown, chemoresistance. It confers survival advantage to cells by transducing signals from growth factor receptors that activate PI3K. The primary aim of this study is to evaluate whether the levels of phosphorylated AKT are associated with disease-free and overall survival in patients with node-positive breast cancer treated with AC and/or AC followed by paclitaxel.

Eligibility: -  INCLUSION CRITERIA
  The NSABP B-28 trial enrolled women from 1995 to 1998 with operable breast cancer with pathologically positive axillary lymph nodes.

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

Clinical trial: Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions

Summary: Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. These cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. BRCA (breast cancer susceptibility gene), is particularly a relevant health problem among Ashkenazi Jews in Israel.

Detailed description: Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions > 5 mm in diameter and 69% for tumors smaller than 5mm.
  In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:
  -  Women with equivocal findings on Mammography, US and/or MRI
  -  Women with discrepancy between CBE(clinical breast examination)and breast imaging
  -  Women with dense breast
  -  Women in high risk for Breast Cancer
  Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.
  The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.
  This phase will include 500 women.

Eligibility: Inclusion Criteria:
  -  Age over 25.
  -  Equivocal breast lesions.
  -  Dense breast tissue.
  -  High-risk for breast cancer
  Exclusion Criteria:
  -  Age under 25.
  -  Pregnancy.
  -  Patients unable to understand and sign an informed consent

Relevance to patient case: not relevant