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

Clinical trial: Combined Breast Cancer Risk Study

Summary: A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk.

Detailed description: This is a prospective, non- interventional study. Women presenting at imaging centers for routine breast cancer screening or breast cancer diagnostic assessment and who provide written informed consent will undergo genetic testing. Subjects will also provide information about their personal medical and cancer history and family cancer history. The results of the genetic test will be combined with the subject's clinical information, family history, and a risk assessment model to validate a new method of predicting breast cancer.

Eligibility: Inclusion Criteria:
  Women without breast cancer:
  -  18 to 84 years of age
  -  Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
  -  No history of invasive breast cancer
  Women with a history of breast cancer:
  -  18 to 84 years of age
  -  Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
  -  Pathologically confirmed invasive breast cancer diagnosed within the past 12 months
  Exclusion Criteria:
  -  Unwilling to provide written informed consent.
  -  Women with history of ductal carcinoma in situ (DCIS).

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

Clinical trial: Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

Summary: A national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in women and men with HR+, HER2-negative advanced or metastatic breast cancer.


Eligibility: Inclusion Criteria:
  -  Patient is an adult, ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines
  -  Patients with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
  -  Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment.
  -  Patient must have either:
  1. Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).
  2. Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease
  3. Non-measurable disease
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  Exclusion Criteria
  -  Patient who received any CDK4/6 inhibitor or any mTOR inhibitor.
  -  Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole
  -  Patients with current inflammatory breast cancer.
  -  Patient has received > 1 chemotherapy for the treatment of advanced/metastatic breast cancer
  -  Patient has received > 2 endocrine therapies for the treatment of advanced/metastatic breast cancer
  -  Patient has central nervous system (CNS) involvement. If patient is fulfilling the following 3 criteria she/he is eligible for the trial.
  1. completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of study and
  2. CNS tumor is clinically stable at the time of screening and
  3. Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases
  -  Patient has active cardiac disease or a history of cardiac dysfunction

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Trastuzumab Plus Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Summary: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer.

Detailed description: OBJECTIVES: I. Assess the toxicity of monoclonal antibody HER2 with carboplatin and paclitaxel in patients with HER2 positive non-small cell lung cancer. II. Determine median time to progression and one year freedom from progression in this patient population. III. Evaluate one year survival rate and overall objective response rate in this patient population.
  OUTLINE: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on day 1. Patients also receive monoclonal antibody HER2 on days 8 and 15. Treatment is repeated every 3 weeks for 6 courses. After 6 courses of treatment, patients may receive monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years and once a year thereafter until disease progression or death.
  PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Recurrent AND/OR Stage IIIB with pleural or pericardial effusion OR Stage IV Must have at least one bidimensionally measurable lesion Must be HER2 positive (1-3+) Brain metastases allowed, if symptoms controlled and not requiring steroids Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: No concurrent steroids Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: Not specified
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No uncontrolled angina pectoris and arrhythmias No myocardial infarction within past 3 months No uncompensated congestive heart failure Ejection fraction at least 45% Other: No active infections Not pregnant or nursing Fertile patients must use effective contraception HIV negative No other active malignancies No evidence of peripheral sensory neuropathy of at least grade 2

Relevance to patient case: definitely relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.
  PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
  -  Determine the efficacy of this treatment, in terms of local control, in these patients.
  -  Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.
  OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.
  Patients are followed at 1, 3, 6, and 12 months.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Diagnosis of a primary or secondary intrathoracic malignancy
  -  Any cell type or origin
  -  Involving the intrapulmonary, mediastinal, or pleural/chest wall
  -  Inoperable primary or metastatic cancer to the lung
  -  Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
  -  Single or multiple lesions that are non-contiguous with vital structures or organs such as:
  -  Trachea
  -  Heart
  -  Aorta
  -  Great vessels
  -  Esophagus
  -  Less than 5 cm in largest dimension
  -  Accessible via percutaneous transthoracic route
  -  Hepatic:
  -  Coagulation profile normal

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with surgery in treating patients who have stage I or stage II non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the acute effects of intraoperative radiofrequency tumor ablation (RFA) in patients with resectable non-small cell lung cancer.
  -  Determine the treatment-related toxicity in patients treated with this therapy.
  -  Determine the dimensions of the RFA lesion produced by the ablation procedure in these patients.
  OUTLINE: Patients undergo intraoperative radiofrequency tumor ablation over 10-15 minutes for each tumor immediately followed by tumor resection.
  PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of malignant non-small cell lung cancer (NSCLC)
  -  Intraoperative needle biopsy confirmation allowed
  -  Resectable disease (stage I or II)
  -  All tissue to be treated by radiofrequency tumor ablation must be completely contained within boundaries of planned lung resection
  -  Medically fit to undergo lung resection
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 18
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior or concurrent biologic therapy
  Chemotherapy:
  -  No prior or concurrent chemotherapy
  Endocrine therapy:
  -  No prior or concurrent endocrine therapy
  Radiotherapy:
  -  No prior or concurrent radiotherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other prior therapy for NSCLC

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: GW572016 For Treatment Of Refractory Metastatic Breast Cancer

Summary: This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.


Eligibility: Inclusion Criteria:
  -  Signed Informed Consent.
  -  Histologically confirmed Stage IIIb or IV breast cancer.
  -  Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
  -  Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
  -  Documented disease progression of the most recent treatment is required.
  -  Archived tumor tissue available for testing.
  -  Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
  -  At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
  -  Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
  -  Able to swallow and retain oral medication.
  -  Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
  -  Adequate kidney and liver function.
  -  Adequate bone marrow function.
  Exclusion criteria:
  -  Pregnant or lactating.
  -  Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
  -  Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
  -  History of other malignancy.
  -  Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
  -  Active or uncontrolled infection.
  -  Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
  -  Known history of or clinical evidence of leptomeningeal carcinomatosis.
  -  Active infection.
  -  Concurrent cancer therapy or investigational therapy.
  -  Use of oral or IV steroids.
  -  Unresolved or unstable serious toxicity from prior therapy.
  -  Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

Detailed description: Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
  -  Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
  -  Measurable disease per RECIST criteria.
  -  Adequate bone marrow, hepatic and renal function.
  Exclusion Criteria:
  -  Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
  -  Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
  -  Known hypersensitivity to minocycline.
  -  History of serious cardiac disease that is not controlled.
  -  Serious eye conditions.
  -  Prior treatment with inhibitors of EGFR of any kind.

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Sputum Cytology in Screening Heavy Smokers For Lung Cancer

Summary: RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early and plan better treatment for lung cancer.
  PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Classify annual sputum samples cytologically in participants with or without airflow obstruction and a heavy smoking history.
  -  Correlate sputum cytological atypia (moderate atypia or worse) with lung cancer incidence in these participants.
  -  Correlate changes in sputum cytology (i.e., changes toward higher grades of atypia) with lung cancer incidence in these participants.
  Secondary
  -  Determine other risk factors for lung cancer (e.g., diet, family history, smoking history, and medications) that may either confound or modify the association between sputum cytology and lung cancer risk in these participants.
  OUTLINE: Two 3-day pooled sputum samples are collected for 6 consecutive days from participants by the spontaneous cough technique for cytopathological evaluation. Participants also complete a risk factor questionnaire and undergo a pulmonary function test by spirometry and a blood draw.
  Participants complete a questionnaire updating smoking, vital, and lung cancer status and undergo sputum sample collection annually.
  Participants are informed of sputum cytology results.
  PROJECTED ACCRUAL: A total of 3,400 participants (2,900 with airflow obstruction and 500 without airflow obstruction) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Current or ex-smoker with a lifetime history of cigarette smoking of ≥ 20 pack years, meeting 1 of the following criteria:
  -  Airflow obstruction
  -  FEV_1 < 75% predicted for age by spirometry
  -  FEV_1/FVC ≤ 75% by spirometry
  -  No airflow obstruction
  -  No history of lung cancer
  PATIENT CHARACTERISTICS:
  Age
  -  25 and over
  Performance status
  -  Not specified
  Life expectancy
  -  More than 5 years
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  No cancer within the past 5 years except nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)

Summary: AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed GBM in first or second recurrence or relapse
  -  Adequate hematologic, hepatic and renal function
  -  Age ≥ 18 years
  -  Karnofsky performance status score ≥ 70%
  -  Life expectancy ≥ 12 weeks
  Exclusion Criteria:
  -  Peripheral neuropathy > grade 1
  -  Diarrhea > grade 1
  -  Gastrointestinal dysfunction
  -  Compromised cardiac function
  -  Concurrent severe and/or uncontrolled medical conditions

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Study of Oral AEE788 in Adults With Advanced Cancer

Summary: AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed solid tumor
  -  Adequate hematologic, renal and hepatic function
  -  Age ≥ 18 years
  -  Karnofsky performance status score ≥ 70%
  -  Life expectancy ≥ 12 weeks
  Exclusion Criteria:
  -  Active brain metastases
  -  Peripheral neuropathy > grade 2
  -  Diarrhea > grade 1
  -  Gastrointestinal (GI) dysfunction
  -  Compromised cardiac function
  -  Concurrent severe and/or uncontrolled medical conditions

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

Summary: The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.


Eligibility: Inclusion Criteria:
  -  At least 18 years old
  -  Metastatic, or unresectable solid tumors from breast, head, and neck, gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma multiforme
  -  ECOG performance status score either 0, 1, or 2
  -  Willing and able to provide written informed consent
  Exclusion Criteria:
  -  Greater than two prior cytotoxic regimens
  -  Laboratory values showing adequate function of bone marrow, liver, and kidneys
  -  Uncontrolled hypertension
  -  Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel, docetaxel) or polysorbate 80

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Self-Gated Breath-Hold Technique for Helical Tomotherapy in Patients With Non-Small Cell Lung Cancer

Summary: Non-small cell lung cancer (NSCLC) is a disease that often cannot be surgically operated on. As a result, treating the tumor with radiation has become the main standard of treatment. Radiation therapy though, is limited by various factors, including the difficulty in properly imaging the lung tumor since the lung can move up to 4 cm between breathing in and out. Consequently, a radiation oncologist must consider a larger area of the lung to treat with radiation - increasing the amount of normal tissue exposed to harmful rays and therefore leading to increased side-effects. Two techniques being explored into improving tumor management while minimizing the side effects in NSCLC are breath-held gating and tomotherapy. Breath-held gating is a technique for consistently imaging the tumor at the right moment in a patient's breathing cycle - decreasing the normal tissue exposed to harmful radiation. Tomotherapy, a new technique in delivering radiation, will further allow the investigators to focus treatment on the tumor and exclude more normal tissues. Therefore, they hope that these methods will prove to be a better way in treating people with NSCLC.

Detailed description: Non-small cell lung cancer (NSCLC) is a disease that often presents as an unresectable tumor. As a result, radiotherapy is the main standard of treatment. Unfortunately, radiotherapy is limited by several factors, including that the lung can move up to 4 cm between inspiration and expiration. As a result, a radiation oncologist often has to widen his treatment field to include for this motion. This leads to greater side effects for the patient. Two techniques that are being explored to improve the tumor control of radiotherapy and to minimize side effects to normal tissues in NSCLC treatment include breath-held gating and tomotherapy. Breath-held gating will allow the investigators to treat patients at the right moment in their breathing cycle consistently - minimizing the normal tissue exposed to radiation. In addition, both gated breathing and tomotherapy will allow the investigators to create a more refined tumor volume treated and exclude more of the normal tissues. Consequently, they hope these methods will prove to be a better way to treat patients with non-resectable NSCLC.

Eligibility: Inclusion Criteria:
  -  Stage I-III NSCLC
  -  Karnofsky Performance Status (KPS) equal to or greater than 70
  -  Forced expiratory volume in 1 second (FEV1) equal to or greater than 1.0L
  Exclusion Criteria:
  -  Myocardial infarction (MI) disease
  -  Recurrent disease
  -  Complete tumour resection

Relevance to patient case: not relevant