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

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: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

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: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

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: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

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: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

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

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

Clinical trial: Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831

Summary: This research study is looking at tissue samples from women with breast cancer who were treated on clinical trial NCCTG-N9831. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the association between the primary breast tumor protein expression of MYC, IGF-1R, and PTEN and disease-free survival (DFS) in patients randomized on clinical trial NCCTG-N9831.
  II. To determine the association between the primary breast tumor amplification status of MYC and TOP2A and DFS in patients randomized on NCCTG-N9831.
  III. To determine the association between the primary breast tumor mutation status of PIK3 and DFS in patients randomized on NCCTG-N9831.
  SECONDARY OBJECTIVES:
  I. To determine the association between the primary breast tumor marker protein expression/amplification/mutation status of the aforementioned markers and overall survival in patients randomized on NCCTG-N9831.
  II. To investigate the predictive potential of multiple marker analyses on DFS and overall survival using multivariate analysis.
  III. To determine the correlation between the protein expression and amplification status of MYC in patients randomized on NCCTG-N9831.
  IV. To determine the correlation between marker protein expression/amplification/mutation status and known clinicopathological characteristics of the tumors.

Eligibility: Inclusion Criteria
  -  Diagnosed with breast cancer and treated on clinical trial NCCTG-N9831
  * Randomized to treatment
  -  HER-2 positive disease
  -  Whole tissue blocks and/or tissue microarray sections available
  -  Hormone receptor status:
  * ER/PR status known
  -  Any menopausal status

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

Clinical trial: Biomarkers in Native American Women With Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients.
  PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.

Detailed description: OBJECTIVES:
  -  Evaluate a selected panel of molecular markers in tissue specimens from Native American women with breast cancer.
  -  Determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients.
  -  Compare and contrast the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry.
  OUTLINE: Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of primary adenocarcinoma of the breast in Native American women
  -  Prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000
  -  Paraffin-embedded tissue available
  -  Paraffin-embedded tissue available from Caucasian women with breast cancer enrolled on NCCTG-77-30-51 or the Mayo Breast Cancer Registry
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Sex
  -  Female

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

Clinical trial: Tamoxifen Resistance in Women With Stage I, Stage II, Stage IIIA, or Stage IIIB Breast Cancer

Summary: RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to tamoxifen resistance.
  PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I, stage II, stage IIIA, or stage IIIB breast cancer.

Detailed description: OBJECTIVES:
  -  Identify women who are resistant to tamoxifen citrate and other drugs for the treatment of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage migration inhibition factor) encoded by resistance-inducing genes (RIGs).
  -  Provide retrospective data on the predictive value of RIGs to serve as the basis for a prospective clinical trial of these genes as predictors of drug resistance.
  OUTLINE: This is a multicenter study. Patients are stratified according to response during tamoxifen citrate (TAM) therapy (resistant group [i.e., those who develop recurrent breast cancer while being treated with TAM] vs conditionally sensitive group [i.e., those who have disease-free survival for over 3 years after initial diagnosis while being treated with TAM]).
  Patients undergo blood collection at baseline, within 3 weeks of initiation of TAM therapy, and then every 6 months for 3 years or until relapse, whichever comes first. Samples are analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e., kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine tRNA-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. An additional blood sample is obtained from patients at the time of relapse, if available.
  Patients also undergo assessment of medical history, personal habits, and characteristics of breast cancer (e.g., tumor histology, stage, and grade) at baseline.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed invasive breast cancer
  -  Initial pathologic stage I-IIIB disease
  -  No stage IV disease
  -  Meets the following criteria for breast cancer therapy:
  -  Received prior primary local therapy for breast cancer
  -  Scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer within 3 weeks
  -  Hormone receptor status:
  -  Estrogen-receptor positive tumor
  -  Female
  -  Pre- or post-menopausal
  -  Must be able to donate 20 mL of blood
  Exclusion Criteria:
  -  Severe anemia, defined as hemoglobin < 11 g/dL
  -  Psychiatric history that would preclude 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: Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Summary: Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.


Eligibility: Inclusion Criteria
  Subjects are admitted into the study only if all of the following eligibility is true:
  -  Female
  -  Age limitation specific to the indication:
  -  Primary Augmentation: Must be 18 years or older
  -  Primary Reconstruction: No age limit
  -  Revision: If original surgery was primary reconstruction, then no age limit. If original surgery was primary augmentation, then must be 18 years or older.
  -  Adequate tissue available to cover implant(s)
  -  Willingness to follow study requirements (informed consent form, follow-up visits)
  -  Candidate for primary augmentation, primary reconstruction, or revision
  Exclusion Criteria
  Subjects are not eligible if any of the following criteria exist:
  -  Advanced fibrocystic disease, considered to be pre-malignant without mastectomy
  -  Inadequate or unsuitable tissue
  -  Active infection in the body at the time of surgery
  -  Pregnant or lactating
  -  Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator
  -  Use of drugs, including any drug that would interfere with blood clotting, that might result in high risk and/or significant postoperative complications
  -  Demonstrated psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure
  -  Determination by physical examination that the subject does have any connective tissue/autoimmune disorder
  -  Existing carcinoma of the breast without accompanying mastectomy
  -  MRI scan is prohibited because of implanted metal device, claustrophobia, or other condition.

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

Clinical trial: Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer

Summary: Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100).
  The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor.
  Patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy.
  Primary objective:
  -  To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies.
  Secondary Objectives:
  -  Overall survival.
  -  Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery.
  -  Histological and seric proteomic exploratory studies.


Eligibility: Inclusion Criteria:
  -  Women aged between 18 and 70
  -  Patient with life condition < 2 (WHO scale)
  -  One-sided breast adenocarcinoma with a histological evidence (all type)
  -  Clinical presentation which allowed a complete surgery with healthy limits
  -  Absence of metastasis detectable at clinical examination or radiology
  -  Histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (N > 1)
  -  The beginning of the chemotherapy within 6 weeks following the primary surgery
  Exclusion Criteria:
  -  All metastatic affect
  -  Tumor classed >= T4a: cutaneous invasion, deep adherence, inflammatory breast
  -  All chemotherapy, hormonotherapy or radiotherapy before surgery
  -  Tumoral residue not removed
  -  Any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled
  -  History of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)

Relevance to patient case: not relevant