araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Lapatinib and Bevacizumab for Metastatic Breast Cancer

Summary: This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.


Eligibility: Inclusion criteria:
  -  Females that are at least 18 years of age.
  -  Women of childbearing potential must have a negative serum pregnancy test at screening.
  -  Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting.
  -  Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic.
  -  Adequate hepatic, renal and cardiac function
  -  ECOG score 0-1 and a life expectancy of at least 12 weeks.
  -  Able to swallow oral medication
  -  Signed informed consent
  Exclusion criteria:
  -  Pregnancy
  -  Unstable or symptomatic CNS metastases
  -  Major surgery within 28 days of enrollment (minor surgery within 7 days).
  -  Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities.
  -  A serious non-healing wound, ulcer, or bone fracture at baseline.
  -  Class II, III or IV heart failure as defined by the NYHA functional classification system
  -  History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension.
  -  History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment.
  -  History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
  -  History of malabsorption syndrome, ulcerative colitis, or bowel obstruction.
  -  Proteinuria
  -  Requires concurrent anti-cancer treatment or investigational treatment.
  -  Known hypersensitivity to either study medication
  -  Received investigational treatment within 28 days or 5 half-lives, whichever is longer
  -  Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study
  -  Requires medication that has been excluded during study participation

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

Summary: This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.

Detailed description: Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.

Eligibility: Inclusion Criteria:
  -  Performance status (WHO) 0-2
  -  Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
  -  HER-2 overexpression 2+ or 3+ using IHC or FISH +
  -  Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
  -  No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
  -  More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
  -  No prior first line chemotherapy for metastatic disease
  -  Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
  -  Paraffin block from the primary tumor available in the research lab
  -  Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
  -  Adequate liver (Bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  -  Adequate cardiac function (LVEF > 50%)
  -  Informed consent
  Exclusion Criteria:
  -  Pregnant or nursing
  -  Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
  -  Positive pregnancy test
  -  Motor or sensory neuropathy > grade 1 according to NCIC Τoxicity Criteria
  -  Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
  -  History of allergic reaction attributed to docetaxel
  -  Psychiatric illness or social situation that would preclude study compliance
  -  Other concurrent uncontrolled illness.
  -  Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer

Summary: RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future.
  PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.

Detailed description: OBJECTIVES:
  -  Utilize molecular assays to identify a panel of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer (ICC) among patients with or without HIV infection.
  -  Perform a nested case-control study assessing the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes in these patients.
  -  Identify HIV-related factors (e.g., CD4 counts, viral load, and highly active antiretroviral therapy [HAART]) that might be associated with the presence or acquisition of specific hypermethylated genes in these patients.
  OUTLINE: This is a longitudinal, multicenter study.
  Patients undergo biopsy for removal of cervical tissue. Patients also undergo blood and urine sample collection. Samples are analyzed for the presence of cancer or changes that indicate that cancer might develop. Patients also undergo colposcopy at baseline and at 3 years.
  After completion of study procedures, patients are followed every 4 months for up to 3 years.
  PROJECTED ACCRUAL: A total of 1,150 patients will be accrued for this study.

Eligibility: INCLUSION CRITERIA:
  -  Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:
  -  Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following criteria:
  -  CIN grade 2-3 or higher
  -  Repeated CIN1 (times 6)
  -  Abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS] or worse)
  -  HIV seropositive
  -  Negative cytology but positive for high-risk human papillomavirus (HPV)
  -  Negative cytology and negative HPV
  -  HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)
  -  >= 18 years of age
  -  Intact cervix
  -  Not pregnant
  -  Able to provide informed consent
  EXCLUSION CRITERIA:
  -  < 18 years of age
  -  Pregnant at screening
  -  Cervix not intact
  -  not able to provide informed consent

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

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: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib

Summary: The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
  -  Subjects must have:
  1. documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR
  2. a documented T790M EGFR mutation
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1.
  -  Sexually active subjects must use an accepted method of contraception during the course of the study.
  -  Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
  Exclusion Criteria:
  -  Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment.
  -  Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
  -  Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
  -  Receiving anticoagulation therapy with warfarin.
  -  Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
  -  Corrected QT interval (QTc) of >0.45 seconds.
  -  Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases.
  -  Requires steroid or anticonvulsant therapy for the treatment of brain metastases.

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib

Summary: The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.


Eligibility: Inclusion Criteria:
  -  Has signed inform consent
  -  Untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer, including the gastro-esophageal junction
  -  Tumor accessible to and patient consent for endoscopic biopsy at study start and after 7 days of single agent Lapatinib
  -  Measurable disease according to RECIST criteria
  -  Male or female > or = 18 years of age
  -  Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
  -  must have adequate organ function as defined by baseline laboratory values
  Exclusion Criteria:
  -  Gastric carcinoid, sarcomas, or squamous cell cancer
  -  Pregnant or lactating females
  -  Intractable nausea, vomiting, or gastro intestinal obstruction requiring decompression and drainage with a gastric tube or nasogastric suction.
  -  patients who require continuous enteral feeding
  -  Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative colitis
  -  Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility

Summary: HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back.
  The purpose of this study is to see if a new regimen will be effective in preventing cancer from coming back. This is a phase II trial. In this trial, patient get a drug regimen that has been tested in small groups of people to see what dose is safe. Researchers now wish to see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking at short-term side effects and risks of the drug. All of the drugs on this regimen can affect the heart which can be a serious side effect. The drugs affect on heart function is a primary focus.


Eligibility: Inclusion Criteria:
  -  adenocarcinoma breast cancer
  -  ECOG performance status of 0 or 1
  -  peripheral neuropathy less than or equal to 1
  -  discontinued hormonal therapy as a chemoprevention while onstudy
  -  LVEF by MUGA > 55%?
  -  Absolute neutrophil count (ANC)> 1000/µL)
  -  platelet count > 100,000/µL)
  -  SGOT OR SGPT < 92.5 units/L
  Exclusion Criteria:
  -  Stage IV breast cancer
  -  any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT breast cancer
  -  pregnant or lactating patients
  -  active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer
  -  previous allergy/hypersensitivity to Doxorubicin, Cyclophosphamide, Paclitaxel, or other drugs formulated in Cremophor EL?
  -  unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months
  -  psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements?
  -  active, unresolved infections
  -  sensitivity to E. coli derived proteins
  -  prior chemotherapy with an anthracycline
  -  prior Herceptin therapy

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples

Summary: RATIONALE: Studying samples of 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 trial is studying gene expression profiling of cervical cancer progression in biopsies and tissue samples from patients with cervical lesions.

Detailed description: OBJECTIVES:
  -  Classify cervical cancer progression at a molecular level using gene expression profiling generated from expression microarrays.
  -  Profile gene expression changes of dysplasia and early carcinoma of uterine cervical tissue at a molecular level using expression microarrays.
  -  Define a set of genes that classify the various grades of cervical cancer/dysplasia at a molecular level.
  -  Compare the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment.
  OUTLINE: Patients undergo colposcopy and a cervical smear is taken for flow cytometry analysis. Patients also undergo 2 biopsies from one clinically abnormal or normal site. Tissue samples are analyzed by gene expression profiling using human expression microarrays containing approximately 40,000 unique sequences. Data analysis consists of defining a set of genes, containing new targets for biomarkers, that classify the biopsies into 3 grades.

Eligibility: DISEASE CHARACTERISTICS:
  -  Clinically suspicious malignant or premalignant cervical lesion
  Criteria
  Inclusion criteria:
  -  Included subjects will be ≥18 years old.
  -  Included subjects will not be pregnant.
  -  Included subjects will have a negative urine pregnancy test.
  -  Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
  -  Included subjects will indicate understanding of the study.
  -  Included subjects will provide informed consent to participate.
  Exclusion criteria:
  -  Individuals <18 years old will be excluded.
  -  Pregnant individuals will be excluded.
  -  Individuals that have had an operation to remove their cervix will be excluded.

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: A Study of ARRY-334543 and Capecitabine 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 capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine 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 and Canada will be enrolled in this study.


Eligibility: Key Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
  -  Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  -  Must be able to take and retain oral medications.
  -  Additional 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).
  -  Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  -  Requiring intravenous (IV) alimentation.
  -  Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
  -  Pregnancy or lactation.
  -  Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
  -  Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
  -  History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
  -  Additional criteria exist.

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital

Summary: To study the quality of life of patients earlier diagnosed for cervical cancer and cervical intraepithelial neoplasia (CIN).

Detailed description: In Thailand, age standardized incidence is 20.9 per 100,000 women-year. Treatment-related survival gain are experienced by side-effect that may reduce quality of life (QoL). We therefore, study the quality of life of patients earlier diagnosed for cervical cancer patients.

Eligibility: Inclusion Criteria:
  -  Thai patients
  -  aged more than 15 years old.
  -  Diagnosed of cervical intraepithelial neoplasia (CIN) or cervical cancer with pathological confirmation. If she has more than one diseases, the most severe will be considered as diagnosis.
  -  Not suffered from confusion or reduced level of consciousness or unable to communicate.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

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