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

Clinical trial: GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

Summary: This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.


Eligibility: Inclusion criteria:
  -  Patients with confirmed breast cancer who have received prior trastuzumab.
  -  Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
  -  Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
  Exclusion criteria:
  -  Patients with certain heart problems.

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

Clinical trial: Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

Summary: This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).


Eligibility: Inclusion Criteria:
  -  Histologically confirmed solid tumors
  -  Advanced colorectal cancer or other adenocarcinomas
  -  Tumor progression after standard chemotherapy, or where none yet approved
  -  At least one unidimensionally measurable lesion
  -  Karnofsky performance >= 70%
  -  Life expectancy of at least 3 months
  -  Age >= 18 years
  -  Signed, written Institutional Review Board (IRB)-approved informed consent
  -  Acceptable liver function:
  -  Bilirubin <= 1.5 x upper limit of normal (ULN)
  -  AST (SGOT) and ALT (SGPT) <= 2.5 x ULN, OR
  -  AST (SGOT) and ALT (SGPT) <= 5 x ULN if liver metastasis
  -  Acceptable renal function:
  -  Serum creatinine within normal limits, OR
  -  Calculated creatinine clearance of >= 60 mL/min/1.73 m2 for certain patients
  -  Acceptable hematologic status:
  -  Absolute neutrophil count (ANC) >= 1500 cells/mm3
  -  Platelet count >= 100,000 (plt/mm3)
  -  Hemoglobin >= 9 g/dL
  -  Urinalysis: No clinically significant abnormalities
  -  Acceptable coagulation status:
  -  Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR
  -  For patients on anticoagulation therapy, status within therapeutic range
  -  For men and women of child-producing potential, use of effective contraception
  -  Tumors accessible for needle biopsy
  Exclusion Criteria:
  -  Significant cardiovascular disease.
  -  A marked baseline prolongation of QT/QTc interval
  -  Long QT syndrome
  -  Required use of medication on dosing days that may cause torsade de pointes.
  -  Infections requiring intravenous (IV) systemic therapy
  -  Pregnant or nursing women
  -  Treatment with chemotherapy or investigational therapy < 4 weeks (28 days) prior to study entry (6 weeks for nitrosoureas, mitomycin C, or Avastin).
  -  Treatment with radiation therapy or surgery either within 2 weeks prior to study entry, or not yet recovered if 2-4 weeks prior to study entry.
  -  Unwillingness or inability to comply with protocol procedures.
  -  Known active uncontrolled infection with HIV, hepatitis B, or hepatitis C
  -  Serious nonmalignant disease (e.g. hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  -  Concurrent use of other investigational agent(s)
  -  Serious concurrent medical illness

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

Clinical trial: T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

Detailed description: OBJECTIVES:
  -  Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.
  OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.
  Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of solid epithelial tumor, including, but not limited to, the following:
  -  Breast cancer
  -  Ovarian cancer
  -  Lung cancer
  -  Uterine cancer
  -  Prostate cancer
  -  HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
  -  Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)
  PATIENT CHARACTERISTICS:
  -  Absolute neutrophil count > 1,000/mm^3
  -  Absolute lymphocyte count > 400/mm^3
  -  Platelet count > 90,000/mm^3
  -  Hemoglobin > 8 g/dL
  PRIOR CONCURRENT THERAPY:
  -  No other chemotherapy within the past 4 weeks

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

Clinical trial: GW572016 In Patients With Advanced Or Metastatic Breast Cancer

Summary: This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.


Eligibility: Inclusion Criteria:
  -  Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
  -  Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
  -  Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
  Exclusion Criteria:
  -  Patients with certain heart problems.

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

Clinical trial: Lung Cancer Location: a Repository

Summary: The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.


Eligibility: Inclusion Criteria:
  -  Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer
  -  Subjects with a prior history of lung cancer
  -  Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer
  Exclusion Criteria:
  -  Altered mental status that would prohibit the giving and understanding of informed consent
  -  Dementia
  -  Psychiatric illness that would preclude adequate compliance with communication for this protocol
  -  Prisoners

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

Clinical trial: Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.

Detailed description: The goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but infrequent responses. Mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most patients who have initial responses to EGFR-TKI eventually progress. The mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood.
  This is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.

Eligibility: Inclusion Criteria:
  Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and who fulfill the following eligibility criteria will be considered eligible for this study.
  -  Patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, EGFR patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy)
  -  Development of disease progression while actively receiving tyrosine kinase inhibitor
  -  Signed informed consent
  Exclusion Criteria:

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

Clinical trial: Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

Summary: The purpose of this research study is to:
  -  see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
  -  see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
  -  see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
  -  see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.
  -  see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

Detailed description: This is a phase II, single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable.
  Patients must have 1 or more of the following features: never smoker or smoking history of < 15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery (depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before their operation. For patients that demonstrate a radiographic response to gefitinib preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years post-surgery. Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of malignancy at Memorial Sloan-Kettering
  -  Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features)
  -  Patients must have been determined to be operable and resectable by the treating thoracic surgeon.
  -  Age >18 years.
  -  Measurable indicator lesions
  -  Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  -  Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active.
  -  Patients may not be receiving any other investigational agents.
  -  Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).

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

Clinical trial: Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Summary: The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.

Detailed description: Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded.

Eligibility: Inclusion Criteria:
  -  Signed informed consent for radiofrequency ablation and surgery
  -  Maximum of 3 lung tumors
  -  Maximum tumor size 5 cm
  -  Must be able to receive standard surgery
  Exclusion Criteria:
  -  Pathological coagulation tests
  -  Pregnant or breast feeding
  -  Maximum tumor size more than 5 cm
  -  Bilateral secondary lung cancer with more than 3 tumors
  -  Inoperable patient

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

Clinical trial: Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds

Summary: Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath


Eligibility: Inclusion Criteria:
  -  biopsy confirmed primary lung cancer
  -  undergoing radiotherapy or chemoradiotherapy
  -  able to perform adequate deep inspiration breath hold
  -  patients of childbearing potential must practice adequate contraception
  -  signed study-specific informed consent form
  Exclusion Criteria:
  -  unable to perform adequate deep inspiration breath hold
  -  prior tumor resection
  -  prior chest or neck RT
  -  pregnant

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

Clinical trial: The Effect of Berries on Lung Cancer Tumors

Summary: The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.

Detailed description: In the United States, more people (161,840 per year) die of lung cancers than of prostate cancer, breast cancer and colon cancer combined. Presently, there are over 43 million current smokers and over 47 million ex-smokers living in the US. Due to the lag time between smoking and the development of cancer, there are significant numbers of ex-smokers and current smokers who may develop lung cancer compared to never smokers.
  Recent studies in animals have shown that berries, given as a dietary supplement, are highly effective against certain types of cancers. In a study involving mice with lung tumors, mice that had consumed a mixture of berries developed fewer tumors and had less tumor growth than mice that did not consume berries.
  The berries used in this study will consist of blueberries, black raspberries, or a mixture of both.

Eligibility: Inclusion Criteria (lung cancer survivors):
  -  men treated for lung cancer, women treated for lung cancer and with no child-bearing potential (hysterectomy, tubal ligation, post-menopausal women)
  Exclusion Criteria (lung cancer survivors):
  -  women who are on hormone replacement therapy
  -  women who are pregnant, or planning for pregnancy
  -  history of lung transplant
  -  prison inmate
  -  inability to take oral medication or food
  -  known or suspected allergy to berries or berry products
  -  HIV patients
  Inclusion Criteria (volunteers):
  -  adult men, adult women with no child bearing potential (hysterectomy, tubal ligation, post-menopausal women)
  Exclusion Criteria (volunteers):
  -  women who are on hormone replacement therapy
  -  women who are pregnant, or planning for pregnancy
  -  history of lung transplant
  -  prison inmate
  -  inability to take oral medication or food
  -  known or suspected allergy to berries or berry products
  -  HIV patients

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

Clinical trial: Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

Summary: The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.

Detailed description: Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.

Eligibility: Inclusion Criteria:
  1. adult (> 18 years) male or female patient
  2. patient has biopsy-proven NSCLC or lung metastasis
  3. patient has been rejected for surgery and has been considered unfit for radiation therapy or chemotherapy
  4. patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan
  5. tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
  6. tumors are accessible by percutaneous route
  7. patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  8. patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5
  9. patient has signed written informed consent prior to any study specific procedures.
  Exclusion Criteria:
  1. patient has undergone previous pneumonectomy
  2. patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
  3. patient has more than 3 tumors / lung
  4. patient has at least one tumor > 3.5 in greatest diameter
  5. tumor is associated with atelectasis or obstructive pneumonitis
  6. patient has renal failure requiring hemodialysis or peritoneal dialysis
  7. patient has active clinically serious infection
  8. patient has history of organ allograft
  9. patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
  10. patient is pregnant or breast-feeding
  11. patient has ECOG performance status > 2
  12. patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.

Relevance to patient case: not relevant