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

Clinical trial: Tamoxifen Study

Summary: To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample.

Detailed description: BACKGROUND:
  Tamoxifen is nominally called an 'anti-estrogen' although it has some estrogen-agonist activities and tends to increase plasma endogenous estrogen levels. Several studies have confirmed that it decreases plasma total cholesterol and LDL-cholesterol and a review of mortality in patients taking tamoxifen as adjuvant therapy for breast cancer indicates a decreased number of vascular deaths in women on tamoxifen compared to those not on this agent.
  DESIGN NARRATIVE:
  Subjects were randomized to receive 10 mg of tamoxifen two times a day or to placebo. The primary endpoint was prevention of invasive breast cancer. The secondary endpoint was the effects on fatal and nonfatal cardiovascular events (coronary heart disease, stroke, and thromboembolic disease) and fractures. A total of 13,388 women at increased risk for breast cancer were randomly assigned to receive either tamoxifen (20 milligrams per day) or placebo. Cardiovascular follow-up was available for 13,194 women. The median follow-up was 57 months; the mean follow-up was 49 months. During long-term follow-up, 76 percent of the tamoxifen participants were compliant with the study therapy; 83 percent were compliant through 24 months of follow-up. To evaluate the effects of tamoxifen in women with and without pre-existing heart disease, the 13,388 women enrolled at the 131 clinical sites were divided into subgroups of those with and without a self-reported history of clinical coronary heart disease, defined as myocardial infarction or angina prior to randomization. Medical records for subjects with suspected cardiovascular events were collected by the clinical sites and forwarded to the NSABP Operations Center for adjudication by investigators who were blinded to treatment assignment. Primary cardiovascular events included fatal myocardial infarction, Q-wave myocardial infarction, and non-Q-wave myocardial infarction. Secondary cardiovascular events included unstable angina (angina requiring hospitalization) and severe angina (angina requiring revascularization). All subjects were included in the analysis using the intent-to-treat principle.

Eligibility: Women over the age of 35 with a 5-year predicted breast cancer risk of at least 1.66 percent or a history of lobular breast carcinoma in situ, life expectancy of 10 years or more, breast examination and mammogram without evidence of cancer, no hormonal therapy within three months prior to randomization, and no history of deep venous thrombosis or pulmonary embolism. .

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

Clinical trial: Establishment of Normal Breast Epithelial Cell Lines From Patients at High Risk for Breast Cancer

Summary: Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.

Detailed description: Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.

Eligibility: Women at high risk for breast cancer, either because they are a member of a high risk breast or ovarian cancer family, or because of a carcinoma of the opposite breast.
  Normal mammogram within past 3 months.
  No suspicious breast or axillary lesions on physical examination.
  No major cardiopulmonary, hepatic or renal 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: Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients

Summary: This research study is designed to work in cooperation with another study being conducted by the National Cancer Institute. The National Cancer Institute (NCI) is studying the effects of a drug called raloxifene on premenopausal women believed to have a high risk of developing breast cancer (98-C-0123).
  In this study, researchers are interested in learning about the effects of raloxifene on the uterus and ovaries of the women participating in the NCI study. To do this researchers plan to conduct ultrasounds on the patients enrolled in the NCI study. In addition researchers plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if found to be necessary.
  The purpose of this study is to determine the reproductive effects of raloxifene on women who have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus (endometrium).

Detailed description: Raloxifene is a selective estrogen receptor-modulating agent that has been recently approved by the FDA for the treatment of osteoporosis in postmenopausal patients. A phase II trial evaluating the safety and efficacy of raloxifene in premenopausal patients at high risk for developing breast cancer has been recently approved by the IRB (98-C-0123). In this protocol, for assessment of the effects of raloxifene on the endometrium and ovaries, patients are scheduled to be studied with transvaginal sonography and hysterosonography, once during their menstrual cycle at periodic intervals. They are also scheduled to have endometrial biopsies as indicated. It is known that all SERMs (clomiphene, tamoxifen and in one small study raloxifene) raise the area under the curve of estradiol levels throughout the cycle in premenopausal women. Our study is designed to study the reproductive effects of raloxifene in these young women with competent ovaries using sonography of the ovaries and endometrium, and correlating it with steroid hormone levels which would be obtained under protocol 98-C-0123.

Eligibility: Women must be enrolled in NCI Study 98-C-0123.

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

Clinical trial: Gallium Nitrate in Treating Children With Brain Tumor, Neuroblastoma, Rhabdomyosarcoma, Non-Hodgkin's Lymphoma, or Refractory Solid Tumors

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: : Phase I trial to study the effectiveness of gallium nitrate in young patients who have malignant brain tumors, neuroblastoma, rhabdomyosarcoma, non-Hodgkin's lymphoma, or refractory solid tumor.

Detailed description: OBJECTIVES: I. Determine the safety and side effects of gallium nitrate (GAN) when used as an anticancer agent in pediatric patients with refractory solid tumors, including malignant brain tumors, neuroblastoma, rhabdomyosarcoma, and non-Hodgkin's lymphoma. II. Evaluate these side effects in these patients.
  OUTLINE: Single-Agent Chemotherapy. Gallium Nitrate, GAN, NSC-15200.
  PROJECTED ACCRUAL: At least 3 patients will be accrued at each dose studied.

Eligibility: DISEASE CHARACTERISTICS: Biopsy-proven rhabdomyosarcoma, non-Hodgkin's lymphoma, or other solid tumor refractory to conventional therapy or for which no effective curative therapy is known Re-biopsy required if disease recurs more than 2 years after initial diagnosis recommended if radiographic abnormalities suggest tumor recurrence within 5 months of completing radiotherapy or chemotherapy
  PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: Karnofsky 50%-100% Life expectancy: More than 4 weeks Hematopoietic: (unless extensive bone marrow involvement) ANC greater than 750 Platelets greater than 75,000 Hepatic: Not specified Renal: Creatinine normal for age OR Glomerular filtration rate at least 50 mL/min per 1.73 square meters Other: Adequate nutritional status No serious uncontrolled infection No pregnant or nursing women
  PRIOR CONCURRENT THERAPY: At least 2 weeks since other anticancer therapy and recovered Prior radiotherapy or surgery for symptomatic lesions allowed provided site of evaluable disease remains untreated Prior bone marrow or stem cell transplantation allowed No concurrent anticancer therapy

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

Clinical trial: Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.
  PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

Detailed description: OBJECTIVES:
  -  Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.
  OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.
  Patients are followed annually.
  PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Curatively treated carcinoma of the breast
  -  Currently taking adjuvant tamoxifen
  -  Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen)
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant or nursing
  -  No contraindications to receiving tamoxifen
  -  No other serious medical problems
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Prior biologic therapy allowed
  Chemotherapy:
  -  Prior chemotherapy allowed
  Endocrine therapy:
  -  See Disease Characteristics
  Radiotherapy:
  -  Prior radiotherapy allowed
  Surgery:
  -  Prior surgery allowed

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

Clinical trial: Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer

Summary: RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors.
  PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.

Detailed description: OBJECTIVES: I. Determine whether the concept of a sentinel lymph node within the axillary nodal basin is valid in staging breast cancer. II. Determine the sensitivity of combined methods of identification of sentinel lymph nodes by patent blue V dye and gamma probe detection in these women.
  OUTLINE: Patients receive patent blue V dye injection peritumorally prior to surgery. Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid injected around the tumor associated with intraoperative gamma probe detection. Nonpalpable tumors receive a localized injection using stereotactic injection techniques. Patients then undergo standard axillary (level I and II) lymph node dissection.
  PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 1 year.

Eligibility: DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I or IIA invasive breast cancer T0, T1, or T2 (no greater than 3 cm), N0 Noninflammatory Nonmetastatic No ductal carcinoma in situ Eligible for breast-conserving surgery Hormone receptor status: Positive or negative
  PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Pre- and postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No allergy or sensitivity to radiopharmaceuticals or patent blue V dye
  PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior neoadjuvant radiotherapy Surgery: No prior breast surgical biopsy or axillary surgery

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

Clinical trial: Tamoxifen in Treating Women With Breast Cancer

Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.
  PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.

Detailed description: OBJECTIVES:
  -  Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years.
  OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients discontinue tamoxifen after at least 2 years of prior treatment.
  -  Arm II: Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression.
  Patients are followed annually.
  Peer Reviewed and Funded or Endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed breast carcinoma that has been completely excised
  -  Clinically relapse free
  -  Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen
  -  No significant endometrial hyperplasia
  -  No patients with negligibly low risk of breast cancer death
  -  Hormone receptor status:
  -  Any status allowed
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Sex:
  -  Female
  Menopausal status:
  -  Any status allowed
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No other life threatening disease
  -  No retinopathy
  -  No psychiatric disorder or other condition that would preclude study compliance
  -  No serious toxicity (e.g., depression) thought to be due to tamoxifen
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  See Disease Characteristics
  Radiotherapy:
  -  Not specified
  Surgery:
  -  See Disease Characteristics
  Other:
  -  Any primary treatment allowed

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

Clinical trial: S9923 R115777 in Treating Patients With Advanced Colorectal Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or advanced colorectal cancer.

Detailed description: OBJECTIVES: I. Determine the response rate to R115777 in patients with disseminated colorectal cancer who have been previously treated for advanced disease. II. Assess the time to treatment failure and survival of these patients with this treatment regimen. III. Determine the frequency and severity of toxicities of this regimen in these patients.
  OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-7 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced colorectal adenocarcinoma Well differentiated OR Moderately well differentiated OR Poorly differentiated Distant metastases not surgically curable Measurable disease No prior treatment for disseminated disease No known brain metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception Must be able to swallow or receive enteral medications through gastrostomy feeding tube No intractable nausea or vomiting No other prior malignancy for the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any adequately treated stage I or II cancer in complete remission
  PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior adjuvant immunotherapy and recovered No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior adjuvant chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No more than 25% of total area of bone marrow irradiated No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery and recovered Other: No concurrent proton pump inhibitors No other concurrent anticancer therapy

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

Clinical trial: Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining radiation therapy and tamoxifen with surgery may kill more tumor cells. It is not yet known which treatment regimen is most effective for stage I breast cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment regimens in treating women who have stage I breast cancer.

Detailed description: OBJECTIVES: I. Compare the effectiveness of wide local excision alone versus wide local excision followed by radiotherapy with or without tamoxifen versus wide local excision plus tamoxifen in women with stage I breast cancer. II. Assess local occurrence in the treated breast, regional recurrence, distant recurrence, death from breast cancer, and occurrence of cancer in the opposite breast in these patients when treated with one of these regimens.
  OUTLINE: This is a randomized study. Patients are randomized to one of four treatment arms. All patients undergo wide local excision of the tumor and axillary node dissection. Arm I: Patients undergo surgery only. Arm II: Patients undergo surgery followed by 25-35 radiotherapy treatments. Arm III: Patients undergo surgery plus oral tamoxifen daily for 5 years. Arm IV: Patients undergo surgery followed by 25-35 radiotherapy treatments and oral tamoxifen daily for five years. Patients are followed every 3 months for 2 years, and then every 6 months thereafter.
  PROJECTED ACCRUAL: A total of 1200 patients (300 per treatment arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed unilateral stage I invasive breast cancer No more than 1 tumor and no greater than 2 cm Grade 1 tumor of any histological type OR No special type OR Mixed type allowed No lymph node involvement No in situ carcinoma only or ductal carcinoma in situ with microinvasion No vascular invasion No Paget's disease of the nipple Well differentiated special type of primary mammary carcinoma including: Tubular Tubular/cribriform Cribriform Papillary Mucoid No lobular, medullary, or other rarer types of mammary carcinomas including: Adenoid cystic Carcinoid Secretory Spindle cell Apocrine No distant metastases Hormone receptor status: Not specified
  PATIENT CHARACTERISTICS: Age: Under 70 Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No other systemic disease that may preclude study No other prior malignancy except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  PRIOR CONCURRENT THERAPY: No other concurrent adjuvant systemic therapy

Relevance to patient case: not relevant