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

Clinical trial: ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Summary: Aromatase inhibitors are the standard treatment for hormone responsive advanced breast cancer. The combination of the aromatase inhibitor exemestane with with another breast cancer drug that blocks epidermal growth factor receptor (EGFR) and Erb-2 activity (lapatinib) is being studied for the possibility of improving response to therapy, and delaying resistance to endocrine therapy.

Detailed description: The recommended dose of lapatinib will be determined in the first part of the study. In the second part of the study, patients will receive the recommended dose of lapatinib and exemestane daily, taken orally.

Eligibility: Inclusion Criteria:
  -  Histological diagnosis of breast cancer
  -  Indication for hormonal therapy (ER and/or PgR positive)
  -  Stage IV disease
  -  Female gender
  -  Postmenopausal status (patients treated with LHRH analogs are eligible for the Phase II part of the study)
  -  At least one target or non-target lesion according to RECIST criteria
  -  ECOG Performance Status 0-2
  -  Adequate bone marrow (neutrophils > or = 1.500/mm³, platelets > or = 100.000/mm³ and hemoglobin > or = 9 g/dl), hepatic (GOT, GPT < 2.5 e bilirubin <1.25 times the value of upper normal limit) and renal (creatinine < 1.25 times the value of upper normal limit) function
  -  Adequate cardiac function (FEVS > or = 50%)
  -  Able to take oral medications
  -  Life expectancy > 3 months
  -  Signed informed consent
  Exclusion Criteria:
  -  Any previous hormone therapy for metastatic disease
  -  More than one line of chemotherapy for metastatic disease (first line chemotherapy is permitted)
  -  Symptomatic cerebral metastases
  -  Planned concomitant radiation therapy in the first month of therapy (for those patients participating in the dose finding phase of the study)
  -  Previous therapy with exemestane, including as adjuvant therapy (previous therapy with non-steroidal aromatase inhibitors is permitted)
  -  Previous or concurrent malignancy in past 5 years (excluding adequately treated basal cel or spinocellular skin cancer and in situ carcinoma of the cervix)
  -  Treatment with experimental pharmacologic therapy within 4 weeks of enrollment in the study
  -  Unable or unwilling to provide signed informed consent
  -  Any concurrent illness that would, in the Investigator's opinion, contraindicate the use of the study drugs.
  -  Active infection
  -  Assumption of CYP3A4 inhibitors or inducers (ketoconazole, itraconazole, fluconazole, macrolide antibiotics, antidepressives, calcium-antagonists, cimetidine, carbamazepine, phenytoin, barbiturates, rifampicin e glucocorticoids)
  -  Pregnancy or lactation
  -  Unable to comply with follow-up
  -  Active hepatobiliary disease (with the exception of Gilbert's syndrome, asymptomatic biliary calculi, hepatic metastases or stabile chronic hepatopathy)

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

Clinical trial: Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy

Summary: Background: Identification of new biomarkers with potential predictive and prognostic role has contributed unequivocally to breast cancer treatment.
  Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER and progesterone- PR), some patients become hormone resistant. In order to identify a possible profile associated to hormonal resistance, some biomarkers have been assessed after short period primary hormone therapy (HT).
  Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and anastrozole in short term hormone therapy.


Eligibility: Inclusion Criteria:
  -  Invasive breast cancer post-menopausal women
  -  Estrogen and/or progesterone receptor positive
  Exclusion Criteria:
  -  Patients with endocrine disease
  -  Hormone therapy users or those who had been pregnant in the last 12 months before the diagnosis
  -  Patients with a negative expression for estrogen and/or progesterone receptors
  -  Women with a history of thromboembolism
  -  Patients who had previously undergone any treatment for breast cancer

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

Clinical trial: Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer

Summary: This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,

Detailed description: Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.

Eligibility: Inclusion Criteria:
  -  Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)
  -  Participants must be planning to have surgery at the Hospital of the University of Pennsylvania
  -  Participants must be able to tolerating lying on the table for about an hour
  -  Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)
  Exclusion Criteria:
  -  Pregnant women
  -  History of severe renal disease
  -  Prior history of breast cancer of the study breast within the last five years.

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

Clinical trial: Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy

Summary: We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. The results will be compared to a control group of normal healthy women. We will try to determine if MRI can be used to predict tumor response and cognitive changes related to the chemotherapy.

Detailed description: In this work we will utilize conventional magnetic resonance imaging as well as a set of advanced magnetic resonance imaging tools to investigate changes in tumor physiology and the human brain resulting from anthracycline-based systemic chemotherapy. We will recruit up to 15 subjects diagnosed with breast cancer and preparing for an anthracycline-based systemic chemotherapy regimen. Each subject will undergo the set of MR imaging tools before therapy, after one therapy session, after four therapy sessions, and at the conclusion of therapy. Conventional MRI methods will be used to quantify tumor-response to chemotherapy for each subject. A control group of up to 15 normal subjects will also be recruited and will undergo MR brain imaging twice with a gap of 6 months between scans. All subjects will also undergo a battery of neuropsychological tests at each imaging session. The results of the neuropsychological tests will be used to quantify cognitive changes for each subject. A final analysis will determine if the advanced MR modalities can be used to predict the response of tumors or human cognition to chemotherapy.

Eligibility: Inclusion Criteria:
  -  Diagnosed with Adenocarcinoma(ER+ve, PR+ve)
  -  Prescribed, but not yet begun, anthracycline based systemic chemotherapy
  -  Not prescribed Avastin
  -  Able to read and write in English
  -  Have signed informed consent
  Exclusion Criteria:
  -  Diagnosed psychiatric disorder
  -  Conditions that would preclude MRI (Pacemaker, metal objects in body, claustrophobia, pregnancy, etc.)
  -  Serious, unstable medical or mental illness
  -  Medical contraindication to any study procedure
  -  Current alcohol or other substance use disorder (excluding nicotine)
  -  Have not read and signed informed consent, or do not understand its contents

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

Clinical trial: Estrogen for Triple Negative Breast Cancer

Summary: The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically confirmed breast cancer which is metastatic.
  -  A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. .
  -  Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2 negative
  -  Patients must have measurable disease.
  -  Eastern Cooperative Oncology Group performance status 0-1.
  -  Patients with bone metastasis at baseline must agree to treatment with intravenous bisphosphonates
  -  Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy regimens administered for treatment of their metastatic breast cancer.
  -  Age >18 years
  -  Life expectancy of greater than 3 months.
  -  Patients must have adequate organ and marrow function as defined below:
  Exclusion Criteria:
  -  systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study
  -  Patients receiving any other investigational agents for breast cancer treatment.
  -  Patients with known brain metastases are excluded 3.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol.
  -  Patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication
  -  Dysfunctional or post-menopausal vaginal bleeding.
  -  Uncontrolled hypercalcemia/hypocalcemia
  -  Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial infarction, deep venous thrombosis or pulmonary embolism.
  -  History of or active hepatic adenoma.
  -  Uncontrolled intercurrent illness
  -  Pregnant women are excluded from this study
  -  Patients with bone metastasis are excluded if they are unable to receive intravenous bisphosphonate therapy due to the risk for developing hypercalcemia.

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

Clinical trial: A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer

Summary: This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented breast cancer
  -  Locally advanced or metastatic breast cancer
  -  HER2-positive breast cancer documented as FISH-positive, IHC 3 + or CISH-positive by local laboratory assessment
  -  Histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer previously treated with multimodality therapy or metastatic breast cancer
  -  Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both: a taxane, alone or in combination with another agent, and Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting
  -  Documented progression of incurable unresectable, locally advanced, or metastatic breast cancer during their most recent treatment regimen
  -  Progression must occur during or after most recent treatment for locally advanced/metastatic breast cancer or within 6 months after completing adjuvant therapy
  -  Adequate hematologic and end organ function
  -  Agreement to use an effective form of birth control throughout the study
  -  Life expectancy ≥ 90 days as assessed by the investigator
  Exclusion Criteria:
  -  Less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy
  -  Prior T-DM1 therapy
  -  History of exposure to cumulative doses of select anthracyclines
  -  History of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued
  -  Brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment
  -  Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, at the time of the first study treatment
  -  History of clinically significant cardiac dysfunction
  -  Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
  -  Current severe, uncontrolled systemic disease
  -  Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment
  -  Pregnancy or lactation
  NOTE: The site selection process has been completed. Patients can enroll at participating sites.

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

Clinical trial: Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

Summary: RATIONALE: Studying samples of blood and tumor 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.
  PURPOSE: This research study is studying biomarkers in tissue and blood samples from patients with early-stage non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Evaluate aberrant methylation patterns in tissue and serum samples from patients with early-stage non-small cell lung cancer (NSCLC) to validate the Johns Hopkins single institutional study.
  -  Attempt to define subgroups of patients at greater risk for recurrent or metastatic disease who may benefit from more aggressive adjuvant therapeutic regimens.
  -  Develop prognostic indicators for disease-specific and overall survival.
  -  Define new potential molecular targets for therapy.
  OUTLINE: Archived tumor and intrathoracic lymph node tissue samples are analyzed for aberrant DNA methylation (p16/CDKN2A, DAP kinase, H-cadherin, APC, and RASSF1A) by methylation-specific PCR. Analyses are then compared with the preliminary data from the Johns Hopkins institutional study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of early-stage non-small cell lung cancer
  -  T1 or T2, N0 disease
  -  Had a lobectomy or greater resection with negative surgical margins (R0 resection)
  -  Available tumor and lymph node specimens from patients enrolled on ACOSOG-Z0040 and ACOSOG-Z0030 trials
  -  Node-negative with recurrent disease within 3 years (cases)
  -  Node-negative patients without recurrent disease (controls)
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: A Study of Compliant Behaviors and Associated Factors of Women Breast Screening

Summary: There were a breast cancer screening activity in Taipei Medical University-Shuang Ho Hospital. We did an intervention with woman who joined the activity.The most important part in the intervention was to know health behavior about the breast cancer prevention.By doing the study, the investigators will know how to promote the health activity in our community.

Detailed description: When the investigators get these women's health behavior imagination, the investigators can know how much breast cancer screening activity do these people have. The most important part for us is to understand how to promote health behavior to women who live around Shuang area.

Eligibility: Inclusion Criteria:
  1. women
  2. can read words
  Exclusion Criteria:

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

Clinical trial: Endoscopic Breast Surgery in Treating Patients With Breast Cancer

Summary: RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.

Detailed description: PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.

Eligibility: Inclusion Criteria:
  -  Breast cancer or prophylactic mastectomy requiring axillary nodal staging
  -  Breast disease (e.g., fibroadenoma, ADH)
  -  Ability to read and/or comprehend consent form and questionnaires
  -  Ability to follow-up per protocol
  -  Not pregnant or breastfeeding
  Exclusion Criteria:
  -  Pregnant or breastfeeding
  -  Evidence of chest wall or skin* involvement
  -  NOTE: *may be endoscopy-assisted

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

Clinical trial: Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer

Summary: The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.
  At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).


Eligibility: Inclusion Criteria:
  -  Female Patients with the diagnosis of Stage 0, I, II and III breast cancer diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady Memorial Hospital
  -  Age: no limit
  Exclusion Criteria:
  -  Stage IV breast cancers

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

Clinical trial: Predicting Pathological Response Within the 1st Week of Chemotherapy Using Diffuse Optical Spectroscopic Imaging

Summary: Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment with little or no change in tumor size or overall outcome.
  The Researchers have demonstrated a previously undescribed "metabolic flare" response observed very early in neoadjuvant treatment in breast cancer patients. The research can determine that this flare is predictive of overall therapy response and is due to both an inflammatory reaction and cell death induced by cytotoxic therapy.

Detailed description: The researcher can use Diffuse Optical Spectroscopic Imaging device to measure and predict the markers of the response in the first weeks of chemo-therapy.
  The oxyhemoglobin flare response can predictive of overall pathological response to chemotherapy in human subjects. These vascular changes can indicate the rapid transient increase and then decrease in oxyhemoglobin concentration in the first hours and days after therapeutic administration. The magnitude and time course of the flare response in patients receiving cytotoxic therapy will differ between pathological responders and non-responders. This oxyhemoglobin "flare response" can be observed In tumors where vascular dynamics are intact.

Eligibility: Inclusion Criteria:
  -  Female, not pregnant, not breastfeeding
  -  greater than 21 years of age but less than 75 years of age
  -  will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist
  Exclusion Criteria:
  -  Under 21 year of age
  -  Female pregnant or breastfeeding

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

Clinical trial: Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients

Summary: The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.


Eligibility: Inclusion Criteria:
  -  ≥ 18 years of age;
  -  Histologically confirmed Stage I-IV breast cancer;
  -  ECOG Performance Status 0-3;
  -  Scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
  -  Growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
  -  Absolute Lymphocyte Count (ALC) > 500 cells/μL as determined by routine CBC with differential;
  -  Signed, IRB approved written informed consent.
  Exclusion Criteria:
  -  Presence of acute, active infection;
  -  History of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
  -  Other co-morbid illness which would impair ability to participate in the study;
  -  Concurrent experimental therapy (Note: concurrent biologic therapy IS permitted, provided it is not experimental).
  -  Prior or current receipt of histone deacetylase (HDAC) inhibitors

Relevance to patient case: not relevant