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

Clinical trial: Self-Care for Lymphedema in Patients With Breast Cancer

Summary: RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan better at-home self-care treatment.
  PURPOSE: This research study is looking at self-care practices for lymphedema in patients with breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To systematically identify and describe the barriers to completing recommended at home self-care of lymphedema in patients with breast cancer.
  -  To identify patient recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others.
  -  To identify the current at home self-care practices of breast cancer survivors with treatment treated lymphedema.
  Secondary
  -  To examine the relationship between at home self-care activities and symptoms in breast cancer survivors with lymphedema.
  -  To examine the relationship between at home self-care activities and quality of life in breast cancer survivors with lymphedema.
  -  To identify patient-perceived benefits to at home self-care.
  OUTLINE: Patients complete questionnaires about their breast cancer diagnosis and treatment history, lymphedema history and problems, and years of education and income. Patients also complete surveys about home self-care practices for lymphedema and any benefits, burdens, or barriers of at home care.

Eligibility: DISEASE CHARACTERISTICS:
  -  History of breast cancer
  -  Lymphedema in one or both arms that occurred during or after breast cancer treatment
  -  Must have received prior lymphedema treatment by a healthcare professional
  -  Patients with self-reported arm swelling subsequent to breast cancer treatment that has not been treated by a healthcare professional are not eligible
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  English speaking
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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 Role of Diet and Lifestyle in Breast Cancer Survival

Summary: Diet has been found to influence hormone production and metabolism which in turn could affect the incidence of hormone related cancers. Consumption of soy-containing foods, known to be rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may have a role in effecting breast cancer risk. Although there is mounting evidence of the positive influence of phytoestrogens on breast cancer risk, very little research has been carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and survival. The DietCompLyf study aims to explore this effect by carrying out an observational study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and use of complementary treatments will also be investigated. Participants are recruited 9-15 months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine samples are collected annually.

Detailed description: Women matching the eligibility criteria are consented at breast cancer follow-up hospital visits. Blood and urine samples are then collected and questionnaires are provided for the participants to take away and return within 4 weeks. The process of sample collection and questionnaire provision is repeated for visit at years 3 and 5.
  Year 2 and 4 study visit vary in that questionnaires including a 7 day food diary are sent to participants at home to be filled in 7 days before their scheduled follow-up appointment. At hospital, blood and urine samples are collected as usual.

Eligibility: Inclusion Criteria:
  -  Women with histologically confirmed invasive primary breast cancer grades I to III.
  -  age up to and including 75 years old
  Exclusion Criteria:
  -  Previous cancer with the exception of basal cell carcinoma
  -  Concomitant primary cancer
  -  Bilateral cancer of the breast
  -  Psychological problems
  -  Cognitive impairment
  -  Poor understanding of English

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

Clinical trial: Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer

Summary: This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.

Detailed description: A phase II trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity profile. Recently initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population.

Eligibility: Inclusion Criteria:
  -  Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
  -  No HER2 overexpression or gene amplification
  -  No previous therapy for metastatic breast cancer is allowed
  -  Age 18-75 years
  -  At least 12 months interval since prior adjuvant therapy with taxanes and/or anthracyclines
  -  Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
  -  Performance status (WHO) 0-2
  -  Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases)
  -  Adequate renal function (serum creatinine <1.5 times the upper normal limit
  -  Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
  -  Written informed consent
  Exclusion Criteria:
  -  Active infection
  -  Brain metastases
  -  History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  -  History of stroke
  -  Anticoagulation therapy (except of low dose aspirin <325mg)
  -  Other invasive malignancy except nonmelanoma skin cancer
  -  Psychiatric illness or social situation that would preclude study compliance
  -  Pregnant or lactating women

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 Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

Summary: The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer


Eligibility: Inclusion Criteria:
  -  Inoperable estrogen receptor positive and HER2 negative breast cancer.
  -  Postmenopausal status.
  -  Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.
  -  Acceptable bone marrow, liver and kidney function.
  Exclusion Criteria:
  -  Prior or concomitant treatment for advanced breast cancer.
  -  Other major cancer in the past 3 years.
  -  Important cardiovascular events in the past 6 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: A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)

Summary: This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).

Detailed description: Patients selected by investigator according to clinical routine

Eligibility: Inclusion Criteria:
  -  Patients with metastatic breast cancer
  Exclusion Criteria:
  -  History of hypersensitivity to Caelyx or its components
  -  Women who are pregnant or breast-feeding
  -  Patients with severe myelosuppression

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

Clinical trial: Chronic Pain After Operation for Breast Cancer

Summary: The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains.

Detailed description: Surgery for breast cancer is followed by acute undesirable sequelae (pain, nausea, vomiting, psycho-social adaptation) and late sequelae with discomfort or more severe neuropathic pain problems in the surgical area due to nerve damage or adjuvant-/radiotherapy. The late sequelae occur in 30-50% of patients but the exact mechanisms (preoperative disposing factors, intraoperative nerve damage/inflammatory response), acute postoperative pain and psychosocial factors remain to be determined in large, detailed, well-described studies, including stratification to modern breast cancer treatment (sentinel node strategy/ radiotherapy/ chemotherapy). The present study will describe in detail preoperative psychosocial/genetic pain mechanisms, intraoperative technique, multi-modal anaesthesia and opioid-reduced analgesia with a detailed, early and late postoperative follow-up with neurophysiological assessment in the surgical area and randomised studies on preventive therapy.

Eligibility: Inclusion Criteria:
  -  Healthy women
  Exclusion Criteria:
  -  Pregnancy
  -  Lactating

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

Clinical trial: Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study

Summary: To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed infiltrating breast cancer.
  -  Stage II or stage III breast cancer.28 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of >2 mm in diameter at sentinel node biopsy. Stage IIA patients are eligible if the tumor is >3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
  -  Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
  -  >10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
  -  >10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating HER2 gene amplification defined as a FISH ratio of HER2 gene copies to chromosome 17 signals of >2.2. or as >5 HER2 gene copies per nucleus in CISH analysis.
  Patients with a negative or equivocal overall result (FISH test ratio of <2.2, <6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.
  -  Age ≥18
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix B)
  -  Adequate bone marrow function (ANC >1.0 x 109/l, platelets >100 x 109/l)
  -  Adequate hepatic function (ALAT, ASAT and bilirubin <2 times upper limit of normal)
  -  Adequate renal function (creatinine clearance >60 ml/min)
  -  LVEF ≥50% measured by echocardiography or MUGA
  -  Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  -  Signed written informed consent
  Exclusion Criteria:
  -  No previous radiation therapy or chemotherapy
  -  No other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
  -  No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
  -  No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.
  -  No concurrent anti-cancer treatment or another investigational drug

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

Clinical trial: Use of Molecular Breast Imaging (MBI) to Detect Additional Disease in Women With Breast Cancer Who Are About to go to Surgery

Summary: Conventional mammography is not a reliable method for determining the extent of disease in women with breast cancer. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that allows the breast to be imaged in a manner similar to mammography, but without the pain of compression. Initial results with this method have shown it is very good at detecting small breast cancers (~1/4 inch).
  The purpose of this study is to see if MBI is a better method than mammography in determining how much cancer is present before a woman goes to surgery.
  The study will comprise 120 women with breast cancer who are going to surgery. The investigators hope that this study will demonstrate that MBI will be more accurate in determining how much cancer is present.

Detailed description: The sensitivity of conventional mammography for evaluation of extent of disease, detection of multifocal breast cancers and contralateral breast cancers is poor. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that permits the breast to be imaged in a manner similar to mammography, utilizing a Cadmium-Zinc-Telluride (CZT) gamma camera. We have developed the first dual-head MBI system in the world and preliminary results from this system indicate a high sensitivity (~90%) for the detection of breast cancers < 10mm.
  The AIM of this study is to determine the sensitivity of MBI relative to mammography in the preoperative evaluation of the extent of disease in the ipsilateral and contralateral breasts in women with biopsy-proven breast cancer. We will test the HYPOTHESIS that MBI is more sensitive than mammography for preoperative evaluation and surgical planning.
  The study will comprise 120 women with biopsy-proven breast cancer prior to surgery. All patients will have a diagnostic mammogram and an MBI study prior to operation. At the time of operation the pathologic findings will be correlated with both the mammogram and the MBI results.
  This study will demonstrate the use of MBI in three aspects of breast cancer diagnosis: 1) detection of multifocal / multicentric disease elsewhere in the ipsilateral breast, 2) detection of contralateral breast cancer, and 3) correlation of index tumor size on MBI with pathologic size. These results may justify a role for MBI in the routine pre-operative evaluation of breast cancer patients.

Eligibility: Inclusion Criteria:
  -  Women with biopsy-proven breast cancer (invasive breast cancer or ductal carcinoma in situ)
  Exclusion Criteria:
  -  Unable to understand and sign the consent form
  -  Pregnant or lactating
  -  Physically unable to sit upright and still for 40 minutes
  -  Currently receiving neoadjuvant chemotherapy or hormonal therapy
  -  Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor
  -  Previous mastectomy
  -  Previous excisional biopsy of the index 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: Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer

Summary: The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).


Eligibility: Inclusion Criteria:
  -  KPS performance status of >= 80% ("normal activity with effort")
  -  Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC")
  -  Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
  -  Measurable disease by RECIST Criteria
  Exclusion Criteria:
  -  Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors
  -  Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
  -  Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits
  -  Moderately severe dry eye
  -  Congestive heart failure, or a left ventricular ejection fraction
  -  Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
  -  Previous malignancies unless free of recurrence for at least 5 years

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

Clinical trial: Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients

Summary: Young women with breast cancer have an increased breast tissue density and conventional imaging tests such as mammography and breast ultrasound are less sensitive and specific for detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool that has been proven to improve the ability to identify breast cancers by determining the extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To date, the role of pre-operative breast MRI is not clearly defined. The investigators are proposing a study to evaluate the impact of preoperative breast MRI on surgical decision-making in breast cancer patients <= 50 years. This may lead to improved characterization of breast cancers in these younger patients that may ultimately result in lower local recurrence rates in the future. The additional information attained through the breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these patients.

Detailed description: Inclusion Criteria:
  -  female aged ≤ 50
  -  histologically proven invasive breast cancer
  Exclusion Criteria:
  -  Is not considered a surgical candidate
  -  Has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed lesion
  -  Has a contraindication to undergoing breast MRI
  -  Has inflammatory breast cancer according to the standard clinical definition
  -  Has locally advanced breast cancer according to the standard clinical definition
  -  Patient is pregnant
  -  Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol

Eligibility: Inclusion Criteria:
  -  Female aged <= 50 years
  -  Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
  -  Premenopausal
  Exclusion Criteria:
  -  Patient not considered an appropriate surgical candidate; i.e., patient is not well enough to have breast cancer surgery
  -  Patient has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed cancer
  -  Patient has a contraindication to undergoing breast MRI (i.e., pacemaker, neurodefibrillator, metallic foreign bodies, etc.)
  -  Patient has inflammatory breast cancer according to the standard clinical definition. This is a type of breast cancer in which there is evidence of erythema and/or edema. The skin of the breast may also have changes of peau d'orange.
  -  Patient has locally advanced breast cancer according to the standard clinical definition.
  -  Patient is pregnant
  -  Patient has a psychiatric or addictive disorder that would preclude them from obtaining 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: PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Summary: The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
  -  Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
  -  Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
  -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  -  Men or women 18 years of age or older
  -  Adequate hematologic, renal, hepatic, metabolic, and coagulation function
  Exclusion Criteria:
  -  History of prior or concurrent central nervous system (CNS) metastases
  -  Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
  -  Clinically significant cardiac disease
  -  Clinically significant peripheral sensory neuropathy
  -  Active inflammatory bowel disease
  -  Recent gastroduodenal ulcer to be active or uncontrolled
  -  History of interstitial lung disease
  -  Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
  -  Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
  -  Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.

Relevance to patient case: not relevant