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

Clinical trial: The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal Women With Advanced Breast Cancer

Summary: The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal Women with Advanced Breast Cancer A Prospective Trial.

Detailed description: The Combination of GnRh Analogue and Aromatase Inhibitor in Receptor Positive Premenopausal Women with Advanced Breast Cancer A Prospective Trial.

Eligibility: Inclusion Criteria:
  -  Receptor Positive Premenopausal Women with Advanced Breast Cancer.
  Exclusion Criteria:
  -  Any woman other than diagnosis of Receptor Positive Premenopausal with Advanced Breast Cancer.

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

Clinical trial: Online Stress Management and Coping Skills Training for Women With Breast Cancer

Summary: Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer.
  This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. In addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support.
  The web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.

Detailed description: Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer.
  This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. In addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support.
  The web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.

Eligibility: Inclusion Criteria:
  -  Diagnosis of stage 0, I, II or III breast cancer within past 18 months
  -  Elevated stress, distress or negative mood
  -  Access at least 1.5 - 2 hours per week to a computer with audio capabilities that is connected to the internet
  -  Ability to read, write, and speak English at a sixth grade level
  -  Access to a telephone and an active e-mail account
  Exclusion Criteria:
  -  Cancer diagnosis is a recurrence
  -  Diagnosis of schizophrenia
  -  Use of anti-psychotic medication
  -  Diagnosis of bipolar disorder without use of mood stabilizing medication

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

Clinical trial: Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery

Summary: Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.


Eligibility: Inclusion Criteria:
  1. KPS>=60
  2. histology confirmed invasive breast cancer
  3. received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
  4. surgical margins negative
  5. primary tumor ≤5cm in the largest diameter
  6. no internal mammary node or supraclavicular node metastases or distant metastasis
  7. can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
  8. for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
  9. for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
  10. patients signed written inform consent form
  Exclusion Criteria:
  1. ductal carcinoma in situ
  2. prior neoadjuvant chemotherapy
  3. prior breast cancer history
  4. bilateral breast cancer
  5. pregnant or during lactation
  6. prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
  7. active collagen vascular disease
  8. prior neoadjuvant hormone therapy
  9. immediate ipsilateral breast reconstruction

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

Clinical trial: Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search

Summary: The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.

Detailed description: The secondaries objectives of the study are:
  -  Sensitivity and specificity in detecting multifocality of breast tumor
  -  Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors
  -  Predetermination of potential targets for ultrasound

Eligibility: Inclusion Criteria:
  -  Age> 18 years.
  -  Patients with a breast tumor, regardless of the stage and size
  -  Compulsory affiliation to a social security system.
  -  Obtaining informed consent in writing, signed and dated.
  Exclusion Criteria:
  -  Patients with cognitive or psychiatric disorders.
  -  Patient deprived of liberty by a court or administrative.
  -  Patients with indications against the achievement of MRI, mammography and tomosynthesis
  -  Pregnant Women

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

Clinical trial: Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer

Summary: Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor positive breast cancer patients
  Phase II multicenter 1:1 randomized clinical trial Total 208 patients
  Primary endpoint Clinical response rate
  Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy Toxicity profile of neoadjuvant letrozole, metformin

Detailed description: To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients

Eligibility: Inclusion Criteria:
  -  Estrogen receptor positive breast cancer
  -  Clinically measurable tumor size(stage II/III)
  -  No evidence of distant metastasis
  -  Postmenopause women 'Age≥60yr' OR 'previous bilateral oophorectomy' OR 'FSH>30 with no bleeding history within 1yr'
  -  ECOG 0-2
  -  Adequate hepatorenal, bone marrow function 'serum Cr<1.4mg/dL' AND 'Bilirubin< upper limit of normal x 1.5 AND 'AST/ALT < upper limit of normal x 1.8 AND 'ALP < upper limit of normal x 1.8 AND 'Hemoglobin >10 g/dL' AND 'ANC >1,500/mm3' AND 'Platelet >100,000/mm3'
  -  Spontaneous signed into the written informed consent
  Exclusion Criteria:
  -  Who does not meet the above inclusion criteria
  -  History of other carcinoma
  -  Uncontrolled infection
  -  History of psychiatric, epileptic disease
  -  Male breast cancer
  -  Diabetes 'HbA1c≥6.5' OR 'FBS≥126mg/dL'
  -  Hypersensitivity or intolerance to metformin
  -  Risk of metformin associated lactic acidosis 'Congestive heart disease of NYHA Class llll/IV' OR 'History of other acidosis' OR 'Alcohol intake more than either 3 bottles beer OR 1 bottle Soju'
  -  During medication of metformin, sulfonylureas, thiazolidinediones, insulin
  -  Diffuse microcalcification in mammogram
  -  Multiple OR bilateral OR inflammatory breast cancer
  -  Chemotherapy or endocrine therapy within 2yr due to history of breast cancer

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

Clinical trial: The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Summary: Selected 400 cases of women with primary breast cancer who were treated with operation randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Detailed description: The investigators selected 400 cases of women with primary breast cancer who were treated with operation randomly,then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Eligibility: Inclusion Criteria:
  1. Provision of informed consent
  2. Pathological confirmation of breast cancer
  3. Tumor stage(TNM):T2-4bN0-3M0
  4. ER(+) and/or PR(+).
  5. Premenopausal woman.
  6. Age≥40 years
  7. Measurable disease as per RECIST criteria
  8. Karnofsky≥70
  9. Laboratory criteria:
  -  PLT≥100*109/L
  -  WBC≥4000/mm3
  -  HGB≥10g/dl
  -  ALT and AST<2*ULN
  Exclusion Criteria:
  1. Presence of metastatic disease.
  2. Inflammatory breast cancer.
  3. Bilateral breast cancer.
  4. previous chemotherapy or hormonal therapy for current breast neoplasm.
  5. other malignant tumor (concurrent or previous).
  6. Pregnant woman.
  7. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
  8. Any severe systemic disease contraindicating chemotherapy.

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

Clinical trial: Predicting Tolerance to Radiation Therapy in Older Adults With Cancer

Summary: A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments. The investigators think this same tool (referred to as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.

Detailed description: A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict for toxicity in older patients during cancer treatments.1 The investigators hypothesize that the same tool (referred to throughout this document as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance. The primary objective of this study is to assess the association between pre-treatment functional status (as measured by the Independent Activities of Daily Living (I-ADL) components of the CGA) and poor tolerance to radiation therapy (as defined in section 2.3.1). Secondary objectives include exploration of associations between pre-treatment I-ADL status on the CGA and the occurrence of any acute grade 3-5 toxicity from radiation therapy, or any decrease in Quality of Life (QoL) measures throughout radiation therapy as assessed by the EORTC QLQ-C30 questionnaire. The investigators also want to compare the rate of physician reported acute toxicities to patient reported acute toxicities in an older cancer patient population, assess any association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to or acute grade 3-5 toxicity from radiation therapy, and explore any association between other baseline components of the CGA and poor tolerance to or acute grade 3-5 toxicity from radiation therapy.

Eligibility: Inclusion Criteria:
  -  ≥Age 65 years (no upper age limit)
  -  Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
  -  Consented for receipt of External Beam Radiation Therapy (EBRT) at UNC Chapel Hill
  -  Able to read English (required for CGA)
  -  Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
  -  Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
  Exclusion Criteria:
  -  ≥Age 65 years (no upper age limit)
  -  Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
  -  Consented for receipt of EBRT at UNC Chapel Hill
  -  Able to read English (required for CGA)
  -  Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
  -  Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)

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

Clinical trial: Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

Summary: Breast density change after short term use of aromatase inhibitor in postmenopausal ER positive breast cancer would predict endocrine responsiveness

Detailed description: Inclusion criteria ER positive breast cancer Postmenopause women Older than 60yr S/P bilateral salphingo-oophorectomy No menstruation history within 1yr and FSH>30mIU/mL Ipsilateral invasive breast cancer Undergone curative resection No evidence of distant metastasis Capable of breast MRI

Eligibility: Inclusion Criteria:
  -  ER positive invasive breast cancer Postmenopause women age 60yrs or older s/p bilateral salphingo-oophorectomy No history of menstruation and FSH>30mIU Planned for aromatase inhibitor Unilateral breast cancer Curative resection No evidence of distant metastasis
  Exclusion Criteria:
  -  Bilateral breast cancer Male breast cancer Acceptable for breast MRI Pregnancy or lactation

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

Clinical trial: Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy

Summary: The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.

Detailed description: The primary purpose of this study is to evaluate the feasibility of implementing a moderate-intensity walking program (Walk With Ease/WWE) among cancer patients, age ≥60 years, as they undergo cytotoxic chemotherapy treatment. Feasibility will be determined based on the rate of participation in the WWE program. As secondary objectives, we will also establish the rate of completion of a number of instruments, including a Geriatric Assessment tool, and other instruments that measure self-reported quality of life (e.g., fatigue, depression, and pain), and self-reported physical activity (PA). Data from these instruments, as well as from serial measurements of a biomarker of aging (p16INK4a) will be explored and used to inform future studies designed to evaluate any relationship between these variables and participation in the WWE program.
  We propose a sample (n=30) of cancer patients ≥60 years of age with potentially curable cancer and a diagnosis of Stage I-III breast cancer, Stage I-III lung cancer, or Stage II-III colon cancer, who are about to begin chemotherapy. Participation will be defined as completing the 6-week WWE program. Results from this study will be used in an RO1 application to the National Cancer Institute (NCI) pertaining to PA interventions among cancer patients and the effects of biomarkers on prognosis and survival.

Eligibility: Inclusion Criteria:
  -  ≥60 years of age, male or female
  -  Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer diagnosis, then the most recent diagnosis); Stage I, II or III lung cancer, or Stage II or III colon cancer
  -  Scheduled to begin a chemotherapy (or concomitant chemoradiotherapy) regimen that will last at least 6 weeks in duration
  -  English speaking
  -  IRB approved, signed written informed consent
  -  Approval from their treating physician to engage in moderate-intensity physical activity
  -  Patient-assessed ability to walk and engage in moderate physical activity
  -  Willing and able to meet all study requirements.
  Exclusion Criteria:
  -  One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
  -  Cancer surgery scheduled within the study period
  -  Unable to walk or engage in moderate-intensity physical activity

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

Clinical trial: Relationship Between Hypoxia and Endocrine Response in Human Breast Cancer

Summary: The aim of our current study was to analyze whether 18F-labeled Fluoromisonidazole (1-(2-nitro-1-imidazolyl)- 2-hydroxy-3-fluoropropane [18F-FMISO]) PET/CT and expression of HIF-1-alpha could predict response of primary endocrine therapy in ER-positive breast cancer

Detailed description: Approximately 30% of ER-positive breast cancer will unfortunately display primary resistance to hormonal therapy, and some may develop acquired resistance to the therapy after initial treatment. Hypoxia is a normal phenomenon in solid tumors that arises, in part, from uncontrolled proliferation and immature blood vessels. Previous studies have demonstrated hypoxia significantly reduced both the growth-promoting effects of estradiol (E2) and the growth-inhibitory effects of an antiestrogen on ER-positive breast cancer cell lines. A recent study comparing neoadjuvant letrozole with letrozole plus metronomic cyclophosphamide found that increased levels of HIF-1a were significantly associated with resistance to treatment. Taken together, these data indicate that hypoxia might be associated with endocrine resistance in breast cancer.
  With PET/CT, radiolabeled hypoxia-avid compounds can be applied to evaluate oxygenation status in experimental or human tumors. 18F-labeled fluoromisonidazole (1-[2-nitro- 1-imidazolyl]-2-hydroxy-3-fluoropropane [18F-FMISO]) PET/CT is the most widely used one in the clinic. Studies have demonstrated an excellent correlation between the 18F-FMISO uptake and oxygenation status of several cancers including breast cancer.
  The major aim of our study was to analyze uptake of 18FFMISO as well as the IHC expression of HIF-1-alpha in ER-positive breast cancers, and to predict the clinical, pathological and biological response of primary endocrine therapy.

Eligibility: Inclusion Criteria:
  1. Postmenopausal female
  2. With primary invasive ER positive breast cancer pathologically approved by core needle biopsy
  3. The target lesion must be measurable and maximum diameter should be over 2cm.
  4. Require and accept Endocrine therapy
  5. Never treated with endocrine therapy before
  6. Patients must have an ECOG performance status of 0 to 2
  7. Leucocyte count must be ≥ 3.0*10^9/L and platelet count must be ≥ 40*10^9/L; AST/SGOT or ALT/AGPT must be < 2 times the ULN; serum creatinine must be < 2 times the ULN
  Exclusion Criteria:
  1. Patients with brain and liver metastasis
  2. Previous history of severe heart dysfunction (above Class III), infection, osteoporosis, bone related event or disease in endocrine system
  3. Combination of other anticancer therapy, with the exception of biphosphonate

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

Clinical trial: Epidemiological Analysis of Vitamin D and Breast Cancer Risk in Saudi Arabian Women

Summary: This is an analysis of de-identified data collected from 240 Saudi Arabian women, 120 with breast cancer and 120 control women, to evalyate if vitamin D status is associated with breast cancer risk.

Detailed description: Background: The role of vitamin D in breast cancer prevention is equivocal. Saudi Arabian women are thought to be at greater risk for vitamin D deficiency due to darker skin type and greater likelihood for reduced UVB radiation exposure. However, there is a lack of data regarding the vitamin D status of Saudi Arabian women and how this may relate to breast cancer risk.
  Objective: The purpose of this research was to evaluate the association between circulating concentrations of 25(OH)D and breast cancer risk in Saudi Arabian women.
  Design: A case-control study was conducted among 120 breast cancer cases and 120 controls. The study population was drawn from patients admitted to King Fahd Hospital in Jeddah, Saudi Arabia from June to August 2009. Participants completed questionnaires on diet and medical history and serum samples were collected from all women to measure circulating 25(OH)D concentrations.

Eligibility: Inclusion Criteria:
  -  Invasive breast cancer (cases) or healthy women (controls),
  -  receiving standard medical check-ups at the women's clinic
  -  Female,
  -  between the ages of 18 and 75 years
  -  BMI ≤ 40 kg/m2
  -  residence in Saudi Arabia for more than 5 years
  -  absence of chronic diseases that could affect vitamin D metabolism, including renal, hepatic, endocrine, or autoimmune disease.
  Exclusion Criteria:
  receiving standard medical check-ups at the women's clinic
  -  Male,
  -  less than 18 or greater than 75 years of age
  -  BMI > 40 kg/m2
  -  Not a resident of Saudi Arabia for more than 5 years
  -  Presence of chronic diseases that could affect vitamin D metabolism, including renal, hepatic, endocrine, or autoimmune disease.

Relevance to patient case: not relevant