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

Clinical trial: Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer

Summary: RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.
  PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.

Detailed description: OBJECTIVES:
  -  Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
  -  Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
  -  Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.
  OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.
  All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed breast cancer
  -  Stage I or II disease (T1-T2, N0, M0/MX disease)
  -  No chest wall invasion by tumor (T3 disease)
  -  Medially or centrally located lesion
  -  No multicentric disease
  -  Multifocal disease allowed
  -  No clinically positive axillary nodes
  -  No enlarged internal mammary nodes by CT scan
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Male or female
  -  Menopausal status not specified
  -  American Society of Anesthesiologists (ASA) physical status classification 1-2
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  No other concurrent known, invasive malignancy
  -  No known chronic pulmonary disease
  -  No known allergy to methylene blue or isosulfan blue
  PRIOR CONCURRENT THERAPY:
  -  No prior thoracic or cardiac surgery
  -  No prior ipsilateral chest tube placement
  -  Contralateral chest tube placement allowed
  -  No prior neoadjuvant chemotherapy
  -  No prior radiotherapy to the mediastinum

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

Clinical trial: Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs

Summary: The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.

Detailed description: This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies.
  Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study.
  Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case.
  A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls.
  Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.

Eligibility: Inclusion Criteria:
  -  cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
  -  controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview
  Exclusion Criteria:
  -  women who are not willing to participate

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 II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

Summary: The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic HER2+ breast cancer not previously treated with chemotherapy or trastuzumab.
  -  Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
  -  Measurable disease
  -  Left Ventricular Ejection Fraction (LVEF) ≥50%
  Exclusion Criteria:
  -  Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)
  -  Relapse within 1 year after (neo)adjuvant taxane or trastuzumab
  -  Neuropathy > Grade 1
  -  Significant cardiovascular disease
  -  Any brain metastases

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 Risk Breast Cancer Screening Program

Summary: Objectives:
  -  To screen population with high risk for breast cancer
  -  To promote the concept and importance of surveillance mammography
  -  To find out the incidence of breast cancer in population who are in high risk for breast cancer
  -  To collect blood samples for molecular analysis


Eligibility: Inclusion Criteria:
  -  Female
  -  > 40 years of age
  -  Women who have first-degree relative suffered from breast cancer
  -  Women who have first-degree relative suffered from ovarian cancer
  -  Family history of male breast cancer
  -  Family history of breast cancer (not necessarily first degree relatives) diagnosed before age of 40
  -  Family history of breast cancer (not necessarily first degree relatives) affecting 2 or more family members
  -  Personal history of ovarian cancer
  -  Personal history of premalignant conditions of breast and ovary
  Exclusion Criteria:
  -  Women with mammogram within one year

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

Clinical trial: Level of Physical Activities in Patients Before and After Breast Cancer Treatment

Summary: Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Detailed description: Introduction: Breast cancer is the most common malignant neoplasy in women. The risk for breast cancer in a lifetime is high among north-american women, about one out of eight, with 66% of the cases occurring after menopause and 15% when women are under 40 years old. Published cohort studies show clear evidences that women who practice intense physical activities have the risk for breast cancer reduced. The risk reduction for these women is 70%, and 10% for those who practice physical activities at a low level. During adolescence and adult age, moderate to intense physical activities may protect against a future breast cancer development. But some questions still need to be answered: Were women with a breast carcinoma diagnosis already physically active during life? Were there changes in these physical activities after treatment? Why? Objectives: The aim of this study was to identify the level of physical activities in patients before and after breast carcinoma treatment, and to observe if there were changes in the level of these activities. Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Eligibility: Inclusion Criteria:
  -  Patients whit diagnosis of breast 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: Prospective & Retrospective Data Collection of Breast Cancer Cases From 2000 to Present

Summary: Prospective & Retrospective data collection of breast cancer cases from 2000 to present


Eligibility: Inclusion Criteria:
  -  Patients with breast 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: Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

Summary: Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

Detailed description: The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.
  Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.
  There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.

Eligibility: Inclusion Criteria:
  -  Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
  -  Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy
  Exclusion Criteria:
  -  Female pregnant and age less than 21 years old and have no diagnosis of breast 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: Registry of Mastectomy for Breast Cancer Risk Reduction

Summary: This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.


Eligibility: Inclusion Criteria:
  -  Patients at an elevated risk for breast cancer.
  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: Local Surgery for Metastatic Breast Cancer

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

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

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

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

Clinical trial: Genetic Studies in Breast Cancer

Summary: The purpose of this study is to determine the specific genetic alterations associated with breast cancer. This will leat to a better understanding of the genetic causes of breast cancer.

Detailed description: It is estimated that 175,000 new breast cancer cases and 44,5000 cancer deaths will result from female breast cancer in 1991. One of the most important risk factors is a family history of breast cancer. A susceptibility allele which accounts for a large proportion of familial breast cancer has been localized to chromosome 17q and attempts to clone the susceptibility are proceeding rapidly. The existence of recognized susceptibility loci and the awareness of a significan proportion of genetic predisposition and the associated penetrances remain unknown and are impossible to estimate without bias from previous studies. This study is designed to estimate heterogeniety and prenetrance in a series of unslected families, identify additional breast cancer susceptibility locs, as well as provide resources for gene isolation and mutation analysis studies.

Eligibility: Inclusion Criteria:
  -  patient with breast cancer under age 41
  -  patient with bilateral breast cancer 41-50 years old or 41-50 years old with a first degree relative (mother, sister, daughter) with breast cancer diagnosed under age 50
  -  patient with ovarian cancer with first degree relative with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 60
  -  patient any age with either ovarian or breast cancer who have 2 first degree rleatives with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 50
  -  relatives of any of the above patients will be included in this trial if a genetic abnormality is found in the patient's blood sample
  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: Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC

Summary: Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative MBC. 80 patients will be treated into this study.

Detailed description: Triple-negative breast tumors could contribute to the poor prognosis comparing with luminal A breast cancer.Fewer study has revealed that Cisplatin-based therapy may be effective for this type breast cancer.

Eligibility: Inclusion Criteria:
  -  Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
  -  Be female and ≥18 and ≤75 years of age
  -  Be ambulatory and have ECOG performance stastus of ≤1
  -  Have histological confirmed breast cancer,and the speciman confirmed ER negative,PR negatiev, and HER-2 negative by immunochemistry technich of Fudan cancer hospital.
  -  Locally advanced or metastastic breast cancer who didn't receive first-line chemotherapy. No matter whether the patient has received anthracyclin or taxane treatment as neo-adjuvant or adjuvant treatment.
  -  Have at least one target lesion according to the RECIST criteria.
  Exclusion criteria:
  -  Preganant or lactating women
  -  Advaced patient has received one or more chemotherapies
  -  Chemotherapy within four weeks preceding treatment start
  -  ECOG ≥ 2
  -  Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
  -  Participation in any investigational drug study within 4 weeks preceeding treatment start
  -  Evidence of CNS metastasis
  -  History of another malignacy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
  -  Abnormal laboratory values: hemoglobin < 8. 0g/dl, neutrophil< 1.5×109/L, platelet< 100×109/L.
  -  serum creatine > upper limit of normal (ULN)
  -  serum bilirubin > ULN
  -  ALT and AST >5×ULN
  -  AKP >5×ULN
  -  Serious uncontrolled intercurrence infection
  -  Life expectancy of less than 3 months

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

Clinical trial: Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

Summary: This study will investigate whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer.


Eligibility: Inclusion Criteria:
  1. A female older than 21 years of age,
  2. Have suspicious imaging findings suggesting a possibility of breast cancer, or biopsy-proven breast cancer.
  Exclusion Criteria:
  1. Pregnant,
  2. Unwilling to give informed consent,
  3. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
  4. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
  5. Have received orthodontic work involving ferromagnetic materials,
  6. Claustrophobic,
  7. Have had allergic response to contrast agents (such as iodine or gadolinium) previously,
  8. Have known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders.

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

Clinical trial: Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics

Summary: RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment.
  PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.

Detailed description: OBJECTIVES:
  -  To correlate data obtained by DCE-MRI and MRS in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology.
  -  To evaluate the impact of MRSI data on treatment planning for radiotherapy and/or surgery.
  OUTLINE: Healthy participants undergo dynamic contrast-enhanced (DCE)-MRI and magnetic resonance spectroscopic (MRS) for longitudinal studies of breast imaging and spectroscopy.
  Patients with breast cancers undergo DCE-MRI and MRS prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). After treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies.
  Breast tissue samples are collected from patients undergoing surgery. Samples are evaluated by histopathological and proteomic analysis for correlation with DCE-MRI and MRS findings.
  The study interventions are discontinued after definitive surgery is performed.
  PROJECTED ACCRUAL: A total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Women with breast tumors planning to undergo surgical resection
  -  Healthy volunteers, including any constitutionally healthy female with no history of breast cancer
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Female
  -  Menopausal status not specified
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  Not acutely ill
  -  No non-magnetic resonance-compatible ferromagnetic materials present in the body
  PRIOR CONCURRENT THERAPY:
  -  Prior chemotherapy and/or radiotherapy allowed

Relevance to patient case: not relevant