araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)

Summary: To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.


Eligibility: Inclusion Criteria:
  -  Age >=18 years, either sex, any race.
  -  Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease.
  -  BREAST CANCER:
  -  participant must have previously received both a taxane and an anthracycline (unless anthracycline therapy is contraindicated) in the adjuvant and/or metastatic setting,
  -  participant with HER2-positive disease must have progressed after trastuzumab and concomitant or subsequent lapatinib,
  -  participant must have received at least one, but no more than two prior regimens for recurrent or metastatic disease (endocrine and biologic therapies do not count as chemotherapeutic regimens).
  -  NSCLC: at least one, but no more than two prior chemotherapeutic regimens for advanced disease.
  -  Measurable disease by the RECIST.
  -  Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
  -  Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
  -  Ability to swallow tablets.
  Exclusion Criteria:
  -  Known brain metastases. For NSCLC only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization.
  -  History of previous radiation therapy to >25% of total bone marrow.
  -  Known HIV infection.
  -  Known active hepatitis B or hepatitis C.
  -  Previous treatment with SCH 727965 or other cyclin-dependent-kinase inhibitors.
  -  BREAST CANCER:
  -  known dihydropyrimidine dehydrogenase deficiency,
  -  previous treatment with capecitabine.
  -  NSCLC: previous treatment with erlotinib.

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

Clinical trial: Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease

Summary: RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.
  PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.

Detailed description: OBJECTIVES:
  -  Correlate optical coherence tomography images of the airway with airway histology.
  -  Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.
  OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Undergoing pneumonectomy or lobectomy for malignant or benign lung processes
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: A Phase I/II Clinical Trial of Vidaza With Abraxane in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer

Summary: The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Detailed description: The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.

Eligibility: Inclusion Criteria:
  1. For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.
  2. For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
  3. Her-2/neu negative (Phase II)
  4. Negative pregnancy test for female subjects
  5. Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.
  6. Male or female for phase I and female for phase II, >19 years of age and any race.
  Exclusion Criteria:
  1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
  2. Known brain metastases
  3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
  4. Active infection requiring antibiotic therapy
  5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
  6. Grade 2 or greater motor or sensory neuropathy
  7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
  8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
  9. Known or suspected hypersensitivity to azacitidine or mannitol
  10. Pregnant or breast feeding
  11. Patients with advanced malignant hepatic tumors
  12. Malignancy other than breast carcinoma (phase II)
  13. Known HIV infection or chronic hepatitis B or C

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

Clinical trial: Radiofrequency Ablation in Resectable Colorectal Lung Metastasis

Summary: Lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In this phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with resectable colorectal lung metastases.

Detailed description: This will be a phase-II clinical trial.
  Lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In this clinical trial, clinical utility of lung RF ablation will be evaluated.
  Patients with resectable lung metastases will receive lung RF ablation.
  All subjects will be followed for overall survival, safety, change in respiratory function, cancer-specific survival, and local tumor progression.

Eligibility: Inclusion Criteria:
  -  Primary lesions (colorectal cancer) are resected.
  -  Lung metastases appear.
  -  No extrapulmonary metastases or after locoregional treatments.
  -  Lung metastasis is considered to be controllable either by metastasectomy or radiofrequency (RF) ablation.
  -  Five or less lung metastases measuring 3cm or smaller.
  -  PET study within 8 weeks before metastasectomy or RF ablation.
  -  White blood count of 3000/mm3 or more.
  -  Platelet count of 100,000/mm3 or more.
  -  Hemoglobin level of 8.0 g/dl.
  -  Serum creatinine level of 2.0 mg/dl or less.
  -  PaO2 of 70 mm Hg or more（Room air）or SpO2 of 93%.
  -  Serum bilirubin level of 2.0 mg/dl or less.
  -  Performance status of 0 or 1.
  -  Expected survival of 1 year or more.
  -  Age of 20 years or more.
  -  Informed consent from the patient.
  Exclusion Criteria:
  -  Risk to injure lung vessels 5 mm or larger.
  -  Lung metastases adjacent to the heart, trachea, esophagus, and aorta.
  -  Association of uncontrollable malignancies.
  -  Lung hilar lymph node metastasis.
  -  One lung.
  -  Pulmonary hypertension.
  -  Coagulopathy.
  -  Impossible to stop using anticoagulants.
  -  Active infection or C-reactive protein of 3 or higher.
  -  Association of active inflammation.
  -  Fever (higher than 38 degrees celsius).
  -  Previous external-beam radiotherapy for the treated lung.
  -  Pregnant.
  -  Judgment to be an inappropriate candidate by a attending physician.

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

Clinical trial: Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


Eligibility: Inclusion Criteria:
  -  Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
  -  Prior use of Herceptin (trastuzumab), and a taxane
  -  Adequate cardiac and renal function
  Exclusion Criteria:
  -  More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
  -  Bone as the only site of disease
  -  Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
  -  Significant gastrointestinal disorder with diarrhea as major symptom

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

Clinical trial: Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

Summary: This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.

Detailed description: This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. Even if the safety profile of the combination of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver events including 14% of severe liver events.

Eligibility: Inclusion Criteria:
  -  Woman aged 18 years or older.
  -  Confirmed pathologic diagnosis of breast cancer.
  -  Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
  -  Surgically sterile or postmenopausal woman.
  -  Documented ER+ and/or PgR+ and erbB2- tumor.
  -  Progression of locally advanced or metastatic disease during treatment with a nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant nonsteroidal AI.
  Exclusion Criteria:
  -  Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
  -  More than 1 prior endocrine treatment for locally advanced or MBC.
  -  More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
  -  Bone or skin as the only site of disease.

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

Clinical trial: A Study of ARRY-334543 and Docetaxel in Patients With Advanced Cancer

Summary: This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in this study.


Eligibility: Key Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of any advanced/metastatic solid tumor suitable for treatment with docetaxel.
  -  Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment.
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  -  Must be able to take and retain oral medications.
  -  Other criteria exist.
  Key Exclusion Criteria:
  -  Active concomitant malignancies.
  -  Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to study start).
  -  Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
  -  Requiring intravenous (IV) alimentation.
  -  Pregnancy or lactation.
  -  Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
  -  Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug.
  -  History of hypersensitivity to or intolerance of docetaxel.
  -  Other criteria exist.

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

Clinical trial: Comfort Level of Two Abdominal Compression Methods Used to Hold Patients Still While Undergoing Stereotactic Body Radiation Therapy for Lung Tumors

Summary: RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Abdominal compression methods that hold the body and the tumor from moving during treatment may permit radiation therapy to kill more tumor cells. This study is looking at the comfort level of two abdominal compression methods in patients with lung tumors undergoing stereotactic body radiation therapy.
  PURPOSE: This phase I trial is studying the comfort level of two abdominal compression methods used to hold patients still while undergoing stereotactic body radiation therapy for lung tumors.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate comfort associated with the existing screw-based abdominal compression device and the new automated abdominal compression device in patients with lung tumors undergoing stereotactic body radiotherapy.
  Secondary
  -  To evaluate tumor motion in patients using these devices.
  OUTLINE: This is a multicenter study.
  Patients undergo fluoroscopic assessment of tumor motion with a screw-based abdominal compression device. Patients then undergo non-contrast 4D-CT imaging with the screw-based abdominal compression device followed by contrast 4D-CT imaging with an automated abdominal compression device.
  Immediately after stereotactic body radiotherapy simulation, patients complete a questionnaire to assess the overall level of comfort of each abdominal-compression device.

Eligibility: DISEASE CHARACTERISTICS:
  -  All lung patients from the University of Texas Southwestern Medical Center, Parkland Health and Hospital System, and Richardson Regional Cancer Center scheduled to receive stereotactic body radiotherapy simulation
  -  Must have initial pre-compression lung tumor motions with respiration > 1 cm
  PATIENT CHARACTERISTICS:
  -  Negative pregnancy test
  PRIOR CONCURRENT THERAPY:
  -  Concurrent participation in other protocols allowed

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

Clinical trial: Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

Summary: The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


Eligibility: Inclusion Criteria:
  -  Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
  -  Been treated for early breast cancer with standard of care duration of trastuzumab.
  -  Could have been treated neoadjuvantly but have not reached pCR.
  Exclusion Criteria:
  -  Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
  -  History of heart disease.
  -  QTc interval >0.45 seconds
  -  History of gastrointestinal disease with diarrhea as the major symptom.

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

Clinical trial: Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Summary: This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.

Detailed description: This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.

Eligibility: Inclusion Criteria:
  -  Surgically sterile or post-menopausal women.
  -  Confirmed pathologic diagnosis of breast cancer.
  -  Locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
  -  Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.
  -  At least 1 radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  Exclusion Criteria:
  -  Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior Src inhibitor.
  -  Prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant Aromatase Inhibitor (AI) agent/regimen is permitted).
  -  More than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer.
  -  Adjuvant endocrine therapy <=12 months prior to day 1 of treatment.
  -  Disease refractory (ie, Progressive disease (PD) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
  -  Bone or skin as the only site of disease.
  -  Extensive visceral disease or active Central Nervous System (CNS) disease.
  -  Any other cancer within 5 years of screening with the exception of ER+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
  -  Major surgery or radiotherapy within 14 days of treatment day.
  -  Inadequate hepatic/renal/bone marrow function.
  -  History of clinically significant or uncontrolled cardiac disease.
  -  Serious concurrent illness.

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

Clinical trial: Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer

Summary: RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer.
  PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate the effects of losartan potassium on the disease progression in patients with stage I-III non-small cell lung cancer and radiation-induced pulmonary fibrosis.
  -  To determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis.
  Secondary
  -  The evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (FEV_1 and FVC) in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive oral losartan potassium once daily for 6 months in the absence of disease progression or unacceptable toxicity.
  Patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and diffusion of gases) by spirometry and dyspnea by the Visual Analog Scale (VAS) at baseline and at weeks 12 and 24.

Eligibility: INCLUSION CRITERIA:
  -  At least 18 years of age or older
  -  Diagnosed with non-small cell lung cancer stage I, II, IIIa, or IIIb
  -  Diagnosis of radiation-induced pulmonary fibrosis (as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] V3.0 Grade I to Grade III) and within 2 years of the last radiation therapy treatment
  EXCLUSION CRITERIA:
  -  Patients with a pneumonectomy
  -  Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
  -  Use of an angiotensin II receptor blocker currently or within 6 months of study entry which include: losartan, valsartan, irbesartan, candesartan, cilexetil, eprosartan mesylate, and telmisartan
  -  Bilateral renal artery stenosis, hereditary or idiopathic angioedema, or uncontrolled hypotension
  -  Patients taking lithium
  -  Currently smoking or smoked within 6 months of study entry
  -  Pregnant, intending to become pregnant or breastfeeding
  -  Baseline systolic blood pressure < 100 mmHg
  -  History of lung transplant
  -  History of kidney failure or liver disease
  -  Inability to attend clinic visits

Relevance to patient case: not relevant