araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: 6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

Summary: An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.


Eligibility: Inclusion criteria:
  1. Female, age 18 years or older.
  2. Histologically proven breast cancer who have not received any prior therapy.
  3. Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.
  4. HER2-positive.
  Exclusion criteria:
  1. Absolute neutrophil count (ANC) less than 1500/mm3.
  2. Platelet count less than 100 000/ mm3.
  3. Hemoglobin level less than 9.0 g/dl.
  4. Bilirubin greater than 1.5 mg/dI.
  5. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.
  6. Serum creatinine greater than 1.5 times of the upper normal limit.
  7. Significant or recent acute gastrointestinal disorders with diarrhea
  8. Pregnancy or breast-feeding.
  9. Organ system dysfunction including cardiac (LVEF < 50%).
  10. Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.
  11. Other malignancies diagnosed within the past five years.
  12. Serious active infection. HIV, active hepatitis B or C.

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Cognitive Impairment in Patients With Heart Failure

Summary: The aim of the present study is threefold: investigating 1) specific cognitive impairments in patients with congestive heart failure, 2) whether cognitive impairments in patients with decompensated heart failure improve after medical recompensation and 3) whether cognitive functioning is related to the long-term prognosis (mortality, rehospitalisation) of those patients.

Detailed description: The daily routine in clinical settings often shows cognitive impairments in patients with congestive heart failure. Recent studies reported declines in cognitive functioning such as executive functions, episodic memory, perceptual speed and attention. However, less is known regarding the differential impairments of cognitive functioning in patients with decompensated heart failure.
  Study objectives:
  1. Identifying specific cognitive impairments in patients with congestive heart failure compared to healthy controls
  2. Evaluating the influence of acute decompensation in congestive heart failure on cognitive functioning
  3. Investigating the effects of medical treatment on cognitive functioning in patients with decompensated heart failure
  4. Exploring long-term effects of cognitive and physiological status on hospitalisation and/or mortality
  Study design:
  Cognitive functions of patients with decompensated heart (NYHA III-IV) failure are compared to age and gender matched patients with congestive heart failure (NYHA III-IV) without symptoms of cardiac decompensation and with healthy controls. Decompensated patients are tested before and after medical recompensation. For matched patients and controls, the pretest-posttest timing is based on the recompensation time of the respective patient with decompensated heart failure.
  The neuropsychological test battery includes measures of episodic memory, working memory, short-term memory, executive functions, perceptual speed and intelligence. In addition, the study applied standardized questionnaires of self assessed quality of life and depression. Relevant physiological data, such as left ventricular systolic function and N-terminal pro brain natriuretic peptide (NT-pro-BNP), are recorded.

Eligibility: Criteria of decompensated heart failure patients
  Inclusion Criteria:
  -  decompensated heart failure patients
  -  NYHA III-IV
  -  ejection fraction < 35%
  Exclusion Criteria:
  -  psychosis
  -  dementia
  -  major depression
  -  reanimation (<3month)
  -  patients with assist device system

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

Summary: RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.
  PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer.
  Secondary
  -  Evaluate local recurrence at 5 years.
  -  Evaluate aesthetic results.
  -  Evaluate quality of life using the QLQC30 and BR23 questionnaires.
  OUTLINE: This is a multicenter study.
  Patients undergo oncoplastic conservative surgery according to defined modalities across the various centers.
  Quality of life is assessed periodically.
  After completion of study treatment, patients are followed every 6 months for 2 years and then for at least 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Diagnosis of intraductal breast cancer requiring a wide local resection
  -  Diagnosis of infiltrating ductal breast cancer within range
  -  Diagnosis of invasive breast cancer that has not responded well to neoadjuvant treatment
  -  No multicentric tumor
  -  No gigantomastia
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  No patients subject to a measure of legal protection or unable to express consent
  -  No patients deprived of liberty by judicial or administrative decision or hospitalized without patient consent
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  -  No prior radiotherapy to the diseased breast
  -  No prior adjuvant treatment
  -  No concurrent participation in another clinical research study

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors

Summary: RATIONALE: A culturally sensitive weight loss program for obese African American breast cancer survivors may be more effective than a standard weight loss program in helping women lose weight.
  PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to see how well it works in African American women who are breast cancer survivors.

Detailed description: OBJECTIVES:
  -  To develop a weight loss intervention for obese African American women who are breast cancer survivors.
  OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 intervention groups.
  -  Group 1: Participants receive traditional individual dietary and exercise counseling in combination with the Weight Watchers weight loss program for 18 months.
  -  Group 2: Participants receive individual dietary and exercise counseling in combination with the Weight Watchers weight loss program as in group 1. They also receive spiritual counseling that incorporates meditation, readings, and the recording of thoughts into a long-term weight management program. The program addresses coping with stress, setting priorities, dealing with emotional issues that trigger old behavior patterns, and developing accountability for following desired diet and exercise patterns.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of breast cancer within the past 5 years
  -  Stage I-IIIA disease
  -  No recurrence of cancer
  -  Identified as African American
  -  Body Mass Index 30-40
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Stable body weight
  -  Not currently following a special diet
  -  No uncontrolled congestive heart failure, untreated hypertension, disabling osteoarthritis, drug or alcohol abuse, or psychiatric conditions that may interfere with counseling
  PRIOR CONCURRENT THERAPY:
  -  More than 3 months since prior chemotherapy or radiotherapy

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Level of HER2-neu Gene Amplification an Response to Trastuzumab

Summary: Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility: Inclusion Criteria:
  -  HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
  Exclusion Criteria:
  -  HER2-negative advanced breast cancer Pretreatment with trastuzumab

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ

Summary: RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.
  PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.

Detailed description: OBJECTIVES:
  Primary
  -  Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).
  Secondary
  -  Evaluate the sensitivity of MRI in detecting DCIS.
  -  Evaluate the contribution of mammography in accurately determining tumor size.
  -  Compare the contribution of MRI vs mammography in assessing tumor extension.
  -  Compare the contribution of MRI vs mammography in assessing dense breasts.
  -  Evaluate the morphology of DCIS by MRI.
  -  Evaluate the curve of dynamic MRI in assessing DCIS.
  -  Evaluate the impact of nuclear grade of DCIS by MRI.
  -  Evaluate the rate of revision surgery.
  OUTLINE: Patients undergo clinical examination, mammography, ultrasound imaging, unilateral breast MRI, and tissue sampling.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of ductal breast carcinoma in situ
  -  Any grade disease allowed
  -  Unifocal disease by mammography
  -  No history of breast cancer
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  WHO performance status 0-2
  -  Glomerular filtration rate ≥ 30 mL/min
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No allergy or contraindication to contrast MRI
  -  No pacemaker or vascular clip
  PRIOR CONCURRENT THERAPY:
  -  No prior or concurrent liver transplantation

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer

Summary: This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.


Eligibility: Inclusion Criteria:
  -  female patients, >=18 years of age;
  -  HER2-positive breast cancer;
  -  al least one metastatic site amenable for core biopsy;
  -  left ventricular ejection fraction >50%.
  Exclusion Criteria:
  -  prior adjuvant/neoadjuvant Herceptin within past 6 months;
  -  prior adjuvant taxane therapy within past 12 months;
  -  use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;
  -  known bleeding diatheses.

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: S9313A Protein Expression in Predicting Response to Treatment Using Tumor Tissue Samples From Women With Stage I, Stage II, or Stage IIIA Breast Cancer Treated on Clinical Trial SWOG-9313

Summary: RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from patients with cancer may help doctors learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.
  PURPOSE: This laboratory study is looking at protein expression in predicting response to treatment using tumor tissue samples from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.

Detailed description: OBJECTIVES:
  -  Assess in-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 by automated quantitative analysis (AQUA™) and multiplexed analysis at 2 markers per slide using tumor tissue from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.
  -  Assess the main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival of patients who received high-dose cyclophosphamide and doxorubicin hydrochloride on clinical trial SWOG-9313.
  OUTLINE: This is a multicenter study. Patients are stratified according to receptor status and menopausal status.
  Tumor tissue samples are analyzed by quantitative protein expression analysis (AQUA™, a fluorescent antibody technique) for estrogen receptor, progesterone receptor, p53 and HER-2. AQUA™ is used to assess markers individually and as ratios with the use of clustering algorithms to define reproducible classifications of tissue from patients treated on SWOG-9313 as a function of molecular classification.
  Results of the AQUA™ testing are compared to immunohistochemistry and fluorescent in situ hybridization (FISH) results obtained on SWOG-9313.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of primary invasive adenocarcinoma of the breast
  -  Stage I-IIIA disease (T1-3, N0-1, M0)
  -  Enrolled on clinical trial SWOG-9313
  -  Tumor tissue available for testing
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer

Summary: RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body.
  PURPOSE: This research study is looking at a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To compare identification of circulating breast cancer cells (CBCCs) in blood or pleural or peritoneal fluid by a novel technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) to the standard technique using the CellSearch® system in women with metastatic breast cancer.
  Secondary
  -  To determine whether CBCCs have the potential to grow into metastatic lesions.
  OUTLINE: Patients undergo sample collection to help develop a new technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) in isolating circulating breast cancer cells (CBCCs) from blood and pleural or peritoneal fluid. Blood may also be drawn to measure the number of circulating tumor cells using the standard CellSearch® system.
  Mononuclear cells are isolated by density centrifugation. Cells are stained against surface antigens that provide specific expression patterns for CBCCs (CD44, CD24). Cells are analyzed on a fluorescence activated cell sorting (FACS) Calibur flow cytometer and sequentially gated (ALDHhigh→CD44+ vs CD24-/low or CD44+ vs CD24-/low→ALDHhigh) for detection of CBCCs. For further confirmation of epithelial origin, ALDHhighCD44+CD24-/low cells are isolated using a FACSAria flow sorter, cytocentrifuged onto glass slides then stained for the expression of epithelial-specific cytokeratins 5, 8, 14, 18 and 19 by standard immunohistochemical techniques. Using the phenotype that is found to most highly enrich for epithelial cells, cells are isolated by FACS and assayed for clonogenic growth.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of the breast
  -  Metastatic disease (stage IV)
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Female
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer

Summary: The purpose of this study is to learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy stops working. However, we do not know if the same molecules change in patients. This study is being done to see if they do change. If we learn more about how patients become resistant, we may be able to offer better treatment in the future.


Eligibility: Inclusion Criteria:
  All patients:
  -  Diagnosed with progressive, recurrent or metastatic HER2+ or ER+ breast cancer.
  Cohort 1
  -  Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, or lapatinib) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-HER2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
  -  Evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by RECIST criteria or new metastasis).
  -  Prior tumor biopsy (may be original) defined as HER2+ by amplification by FISH (>1.9 gene copy number) or IHC 3+.
  Cohort 2
  -  Patients who previously received treatment with hormonal therapy (including tamoxifen, toremifene, raloxifene, anastrozole, letrozole, exemestane, fulvestrant, ARN-810) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.
  Cohort 3
  -  Patients not eligible for Cohorts 1 or 2, but previously received treatment of any other kind for breast cancer.
  Exclusion Criteria:
  -  Patients who are unable to consent to a biopsy.
  -  Patients for whom a repeat biopsy would be medically unsafe

Relevance to patient case: definitely relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Study of Tumor and Blood Samples From Women With Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Assess relapse locally or remotely using biomarkers collected from primary tumor and blood samples from women with breast cancer during the first 2 years after diagnosis.
  Secondary
  -  Evaluate all relapses.
  -  Assess survival without relapse.
  -  Determine correlation between biomarkers and relapse.
  OUTLINE: Primary tumor and blood samples collected during usual care of patients during the first 2 years after diagnosis are analyzed for biomarkers useful in monitoring and diagnosing breast cancer.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of infiltrating unilateral breast cancer
  -  No in situ disease (ductal or lobular)
  -  No invasive bilateral synchronous disease
  -  Breast cancer at high risk, defined by at least 2 of the following factors:
  -  Hormone receptor negative (HR-)
  -  Axillary node positive
  -  Histopathologic grade III
  -  High mitotic index (as defined by the Curie Institute as > 20 mitoses per 10 high-power fields [HPF])
  -  Tumor size ≥ 2 cm
  -  HER2-positive (3 + IHC or FISH/ICHS positive)
  -  Triple-negative tumors (HR- and HER2-negative)
  -  Initial thoracic-abdomino-pelvic and bone scans must be negative
  -  Underwent initial surgery
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Serum calcium normal (15.3 mg/dL) or normalized within 8 weeks after surgery
  -  No other invasive cancer within the past 5 years
  -  Not pregnant or nursing
  -  No psychological, familial, social, or geographical reasons that make monitoring impossible
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: definitely relevant