araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

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: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease

Summary: This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol.

Detailed description: Background:
  -  Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.
  -  Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigators and the IRB.
  Objectives:
  -To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol.
  Eligibility:
  -Patients who were previously enrolled on a CCR protocol and who are not eligible for an active NCI intramural primary research protocol.
  Design:
  -  The medical procedures/tests will be based on the patient's diagnosis, treatment and supporting clinical information. This is a follow-up study in which only standard tests and procedures are to be performed.
  -  Clinical information that is relevant to the patients prior protocols will be collected for research purposes.
  -  Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.

Eligibility: -  ELIGIBILITY CRITERIA:
  Patients of any age who were previously enrolled on a CCR protocol.
  Not eligible for or unwilling to participate in an active NCI intramural primary research protocol.
  CCR investigator decides it is in the best interests of the patient and the CC for the patient to be seen in follow-up visits at the NIH.
  Patient or guardian is able to provide informed consent.

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma

Summary: RATIONALE: EF5 may detect the presence of oxygen in tumor cells and help plan effective cancer treatment.
  PURPOSE: Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen in tumor cells of patients who are undergoing surgery or biopsy for breast, prostate, or cervical cancer or high grade soft tissue sarcoma.

Detailed description: OBJECTIVES: I. Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal binding in resected tumor specimens or tumor biopsies in patients with breast, head and neck, prostate, or cervical carcinoma or high grade soft tissue sarcomas. II. Define the toxic effects of EF5 in this patient population.
  OUTLINE: This is a dose-escalation study. Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 24-48 hours after EF5 treatment, patients undergo surgical resection or biopsy of tumor. Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or preceding the MTD and resulting in optimal tumor-to-normal-tissue binding. Patients are followed at 28 days.
  PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 12-18 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven breast, head and neck, prostate, or cervical carcinoma or high grade (defined as grades 2 or 3) soft tissue sarcoma Sarcoma tumors must be confined to truncal or extremity locations Must have a clinical condition and physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection Tumors no greater than 15 cm in any diameter Hormone receptor status: Not specified
  PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No significant cardiac disease that would preclude the safe use of general anesthesia Pulmonary: No significant pulmonary disease that would preclude the safe use of general anesthesia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study No grade 3 or 4 peripheral neuropathy
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Phenoxodiol in Treating Patients With Refractory Solid Tumors

Summary: RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
  PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.

Detailed description: OBJECTIVES:
  -  Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
  -  Determine the steady-state pharmacokinetics of this drug in these patients.
  -  Determine the tumor response in patients treated with this drug.
  OUTLINE: This is a multicenter, dose-escalation study.
  Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
  Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
  Patients are followed at 4 weeks.
  PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed solid tumor
  -  Refractory to standard therapy OR
  -  No standard therapy exists
  -  No breast cancer
  -  No active CNS metastases
  -  Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  At least 3 months
  Hematopoietic:
  -  Platelet count greater than 100,000/mm^3
  -  WBC greater than 3,000/mm^3
  -  Neutrophil count greater than 1,500/mm^3
  -  Hemoglobin greater than 10 g/dL (9 g/dL for women)
  Hepatic:
  -  Bilirubin less than 1.2 mg/dL
  -  Transaminases no greater than 3 times upper limit of normal
  Renal:
  -  Creatinine no greater than 1.4 mg/dL
  Other:
  -  No active infection
  -  No contraindication to the insertion of a vascular access device
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent systemic anticancer immunotherapy
  Chemotherapy:
  -  No concurrent systemic anticancer chemotherapy
  Endocrine therapy:
  -  No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists
  Radiotherapy:
  -  See Disease Characteristics
  -  Concurrent localized radiotherapy for control of local disease complications allowed
  Surgery:
  -  See Disease Characteristics
  Other:
  -  Recovered from prior antineoplastic therapy
  -  At least 4 weeks since prior investigational agents
  -  No other concurrent investigational drugs

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of radiation therapy during surgery followed by whole-breast radiation therapy in treating women who have undergone lumpectomy for ductal carcinoma in situ or invasive breast cancer

Detailed description: OBJECTIVES:
  -  Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast.
  -  Determine the local recurrence rates in patients treated with this regimen.
  -  Determine the cosmetic outcome in patients treated with this regimen.
  OUTLINE: Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity. Postoperatively, patients undergo external beam radiotherapy to the entire breast 5 days a week for 5-6 weeks.
  Patients are followed at 1 month and then every 3 months for 2 years.
  PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed ductal carcinoma in situ or invasive adenocarcinoma of the breast
  -  Primary tumor classified as T1, T2, or T3
  -  Candidate for breast-conserving surgery
  -  Must have undergone lumpectomy with negative margins or minimal margin involvement
  -  Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
  -  No evidence of metastatic disease
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age
  -  Adult
  Sex
  -  Female
  Menopausal status
  -  Not specified
  Performance status
  -  ECOG 0-2
  Life expectancy
  -  Not specified
  Hematopoietic
  -  WBC greater than 3,500/mm^3
  -  Granulocyte count greater than 1,500/mm^3
  -  Platelet count greater than 100,000/mm^3
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant
  -  No other malignancies within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  -  Prior contralateral breast cancer allowed if curatively treated more than 5 years previously
  -  No severe psychiatric or medical illness
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  No prior radiotherapy to the involved breast
  Surgery
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
  PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.


Eligibility: Inclusion Criteria:
  -  Confirmed infiltrating adenocarcinoma of the breast
  -  Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
  -  No prior radiation to the involved breast
  -  ECOG (Electrocochleography) performance status 0-2
  -  Age 18 years to 80 years
  -  Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl
  -  All liver function tests < upper limit of normal
  -  Serum creatinine < 2.0 mg/dl
  -  Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated Acquisition) scan or echocardiogram
  -  HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test. [FISH (+) is HER-2/neu (+)]
  -  If female of childbearing potential, pregnancy test is negative
  -  If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study
  -  Informed consent has been obtained
  Exclusion Criteria:
  -  Non-confirmed infiltrating adenocarcinoma breast cancer
  -  Evidence of metastasis
  -  Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin
  -  Prior radiation to the involved breast
  -  Recent breast cancer drug therapy within last 5 years of any form
  -  History of allergy to polysorbate or castor oil
  -  Ongoing active infection
  -  Concurrent life-limiting disease with a life expectancy of less than one year
  -  Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix
  -  Pregnancy, nursing, fertile women who do not use birth control device
  -  Inability to give informed consent
  -  Patients with pre-existing peripheral neuropathy > grade 2

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: The Study of Infrared Imaging on Breast Cancer

Summary: Breast cancer can cause focal temperature increase on the breast skin due to vasodilatation mediated by NO secretion from cancer cells. Our study is to evaluate this situation and to assess the diagnostic efficacy of infrared imaging (thermography)on breast cancer.

Detailed description: Malignant breast neoplasms can secrete NO to induce focal vasodilatation and increased blood flow and angiogenesis to the tumor, thus increase the focal temperature, which can be evaluated by breast thermography (infrared imaging). We will evaluate the efficacy of infrared imaging for detection and diagnosis of breast cancer, and if infrared imaging can effectively differentiate malignant from benign breast dieases and the sensitivity, specificity, false-negative rate will also be estimated.

Eligibility: Inclusion Criteria:
  -  normal group: women who has normal mammograms or ultrasound in 6 months abnormal group: women who has suspicious findings on mammograms or ultrasound in recent 6 months
  Exclusion Criteria:
  -  women who don't fit the above inclusion criteria

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Summary: To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.


Eligibility: Inclusion Criteria:
  1. Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ
  2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
  3. Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
  Exclusion Criteria:
  1. Men
  2. Prior malignancy, breast or other if metastatic or with anticipated survival of < 5 years
  3. Pregnant women
  4. Immunocompromised
  5. Poorly controlled insulin dependent diabetes
  6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
  7. Breast cancer that involves skin or chest wall
  8. Multifocal or Multicentric breast cancer
  9. Invasive lobular carcinoma
  10. Diffuse microcalcifications on mammography
  11. Invasive carcinoma with extensive intraductal component (EIC)
  12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
  13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
  14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
  15. Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Scintigraphic Assessment of I- Transport in Metastatic Breast Cancer and Evaluation of I31I Ablative Therapy: (Part I) Radioiodide Imaging Study

Summary: The purpose of this study is to examine breast cancers that express the protein (NIS) that may be found in malignant breast tissues and to evaluate proteins found in blood and their relationship to NIS, to test whether iodide can be concentrated by breast cells to possibly treat some breast cancers with radioactive iodine, and to calculate the amount of radioactive iodine entering breast cancer cells, how long your cancer retains the agent as well as how much is taken up by other organs, particularly the thyroid gland.

Detailed description: To demonstrate iodide uptake capacity of breast cancer metastases by imaging women with iodide radioisotope (123I) and calculating potential ablative dose of radioactive iodide (131I).

Eligibility: Inclusion Criteria:- Only women diagnosed with breast cancer
  -  18 years of age or older
  -  From whom informed consent can be obtained
  -  Patient is able to provide a fluid (e.g. cyst fluid)
  -  Patient with blood test that shows protein may allow iodide to accumulate in breast tissue
  -  Patient who's breast cancer cells accumulated I123 and held on to it for 24 hours
  Exclusion Criteria:- Males
  - Children

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Expanding Rural Access: Distance Delivery of Support

Summary: The major goal of this project is to test the feasibility and acceptability of using videoconferencing to provide support groups led by trained facilitators to rural women with breast cancer in northern California.

Detailed description: Women with breast cancer in rural areas are likely exhaust their usual sources of psychosocial support while still facing challenges posed by breast cancer, but are unlikely to have access to professionally-led support groups. In this community-based project, we assessed the feasibility and acceptability of providing support groups to women with breast cancer in a large rural area using videoconferencing and a workbook journal, and we assessed the intervention’s potential to reduce distress and increase emotional expression and self-efficacy for coping with cancer. Twenty-seven women in the Intermountain Region of northeastern California participated in 8-session support groups led by an oncology social worker by going to nearby videoconferencing sites. Feasibility and acceptability were demonstrated. Older as well as younger women were comfortable using videoconferencing and said the groups were valuable because they promoted information sharing and emotional bonds with other women with breast cancer. They emphasized the importance of a professional facilitator and identified advantages of using videoconferencing for support groups. Pretest and posttest comparisons showed significant decreases in depression and posttraumatic stress disorder symptoms. The results suggest that the intervention has the potential to provide a valuable service that is not readily available in rural communities.

Eligibility: Inclusion Criteria:
  -  1) has been diagnosed with breast cancer, and 2) is a woman
  Exclusion Criteria:
  -  1) under 21 years of age, and 2) does not speak and read English

Relevance to patient case: not relevant