araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China

Summary: This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite standard therapy, or for which no standard therapy exists.


Eligibility: Inclusion Criteria:
  1. Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation
  2. Locally advanced or metastatic breast cancer despite standard therapy and the following:
  1. Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen receptor-positive and/or PR+)
  2. ≤ 2 prior lines of chemotherapy in advanced or metastatic setting
  3. Prior platinum therapy allowed as long as no disease progression while on treatment, or if given in neoadjuvant/adjuvant setting with ≥ 6 months from last platinum to relapse
  4. Prior therapy with an anthracycline and a taxane in neoadjuvant/adjuvant or metastatic setting
  5. Archival tumor tissues will be collected from all patients, if available
  6. For HR(+)/HER2(-) breast cancer only: patients must have received and progressed on at least one endocrine therapy either in adjuvant or metastatic setting, or have disease that the treating physician believes to be inappropriate for endocrine therapy
  3. Measurable disease as defined per RECIST, version 1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  5. Adequate hematologic and organ function
  Exclusion Criteria:
  1. Unresolved acute effects of prior therapy of ≥ Grade 2
  2. Prior treatment with a PARP inhibitor
  3. Chemotherapy, radiotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤ 5 half lives, if applicable, whichever is shorter) prior to Day 1 of Cycle 1
  4. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 14 days prior to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the course of the study
  5. Diagnosis of MDS
  6. Other diagnosis of malignancy
  7. Untreated and/or active brain metastases.
  8. Active infection requiring systemic treatment, active viral hepatitis, or active tuberculosis
  9. Clinically significant cardiovascular disease
  10. Pregnancy or nursing
  11. Known history of intolerance to the excipients of the BGB-290 capsule

Relevance to patient case: not relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

Summary: Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Detailed description: Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Eligibility: 1. Woman or man, with or without cancer, carrying a deleterious BRCA1/BRCA2 mutation, aged 18 years and over.
  1. Woman with or without breast cancer or ovarian cancer at baseline.
  2. Man with or without breast cancer at baseline.
  2. Signed consent to participation
  3. Affiliation to a social security regimen, or beneficiary of such a regimen.
  Exclusion Criteria:
  1. A person of legal age subject to a legal protection measure, or unable to express consent.
  2. Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons

Relevance to patient case: possibly relevant
Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests

Summary: The purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Detailed description: The risk associated with a genetic predisposition is among the various forms of risk, the strongest identifiable risk . It enables to offer people at risk an appropriate medical care (screening, prevention ) the clinical benefit is validated today. The person with whom a predisposing mutation has been identified must communicated its related information on the risk of cancer and the ability to perform genetic analysis. It appears that this dissemination of information is not always optimal, as shown in figures from the National Cancer Institute joined the project; the purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Eligibility: Inclusion Criteria:
  -  Patient having a deleterious genetic mutation on genes BRCA1 and/or BRCA2 and or on genes MMR
  -  The patient being of the family (who carried out a full analysis of BRCA1/BRCA2 and/or those MMR )
  Exclusion Criteria:
  -  Patient not carrying a deleterious genetic mutation on the BRCA1/2 genes and/or those of the MMR system,
  -  Patient under guardianship, curator or unable to give his non-opposition,
  -  Adult patients protected by law.

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: High-dose ICE With Amifostine

Summary: The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses.


Eligibility: Eligibility Criteria:
  -  Histologically documented malignancy
  -  Metastatic or locally unresectable malignancy
  -  Patient may be responding to therapy
  -  Responding Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols)
  -  Relapsed germ cell carcinomas
  -  Relapsed lymphomas (ineligible for other BMT or SCT protocols
  -  SCLC in PR or CR
  -  Sarcomas in or near complete remission after induction chemotherapy
  -  Stage IIIB NSCLC responding to chemotherapy
  -  Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary
  -  Other tumors without curative or first line therapy (not eligible for phase II or III studies)
  -  Aged 18 to 55 Physiologic years
  -- Performance status: PS 0-1
  -  Prior Treatment
  -  > 1 week since surgery or RT
  -  > 3 weeks since prior CT
  -  Informed Consent
  -  Required initial laboratory data:
  -  White Cell Count Life ≥ 3000/ul
  -  Platelet Count ≥ 100,000/ul
  -  Creatinine ≤ 1.5 x normal
  -  Bilirubin ≤ 1.5 x normal
  -  No current metastases
  -  BM Asp & Bx
  -  Brain CAT
  -  Creatinine Clearance ≥ 60 cc/min
  -  SGOT < 2.5 x normal
  -  No other serious medical or psychiatric illness which would prevent informed consent or general anesthesia
  -  Uncontrolled or severe cardiovascular disease including recent (< 6 months) myocardial infarction, or congestive heart failure
  -  Active uncontrolled bacterial, viral, or fungal infection; or an active duodenal ulcer; until these conditions are corrected or controlled
  -  Pregnancy
  -  Unable to stop taking antihypertensive medication 24 hours prior to administration of Ethyol

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma

Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
  PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of imatinib mesylate, as measured by response rate, in patients with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have failed one or more prior treatment regimens.
  -  Determine the clinical and laboratory toxic effects of this drug in these patients.
  OUTLINE: This is a multicenter study. Patients are stratified according to disease subtype.
  Patients receive oral imatinib mesylate twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 60-120 patients (6-12 per stratum) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma
  -  Eligible subtypes:
  -  Ewing's family (e.g., primitive neuroectodermal tumor)
  -  Osteosarcoma
  -  Synovial sarcoma
  -  Rhabdomyosarcoma (e.g., alveolar, embryonal, or pleomorphic)
  -  Liposarcoma (all variants)
  -  Malignant fibrous histiocytoma
  -  Peripheral nerve sheath (e.g., malignant peripheral nerve sheath tumor, neurofibrosarcoma, or schwannoma)
  -  Fibrosarcoma
  -  Angiosarcoma (all variants)
  -  Failed standard therapy with no available salvage regimens
  -  Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical examination
  -  Must be outside prior irradiation fields or have documented disease progression at least 6 weeks after completion of prior radiotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  10 and over
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin no greater than 3 times upper limit of normal (ULN)
  -  ALT and AST less than 2.5 times ULN
  Renal:
  -  Creatinine less than 1.5 times ULN
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective barrier contraception during and for at least 1 week after study participation for female patients and for at least 3 months after study participation for male patients
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  No hormonal birth control
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 3 weeks since prior radiotherapy and recovered
  Surgery:
  -  Not specified
  Other:
  -  At least 28 days since any prior systemic therapy

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Adoptive Immunotherapy for CMV Disease

Summary: Treatment strategy of patients:
  Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.
  Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.
  Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.
  Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.
  Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.


Eligibility: Inclusion Criteria:
  -  For Patient:
  -  Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
  -  Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
  -  Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
  -  Patients with HLA phenotype for which a relevant peptide for CMV exists.
  -  For Donor:
  -  Consenting sibling >18 years old.
  -  HLA phenotype for which a relevant peptide for CMV exists.
  Exclusion Criteria:
  -  For Patient:
  -  Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
  -  For Donor:
  -  Consenting sibling >18 years old.
  -  HLA phenotype for which a relevant peptide for CMV exists.
  -  Donor with an infectious disease (e.g. HIV-1; HBV, etc.)

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Food Rheology and Feeding in Lean and Obese Humans

Summary: The 2010 National Health Objectives call for a reduction in the prevalence of obesity. The marked recent increase in overweight and obesity prevalence implicates behavioral factors in the etiology of the epidemic. The present proposal hypothesizes the trend is attributal, in part, to increasing consumption of energy-yeilding beverages since they are a significant and increasing source of dietarty energy and they elicit weaker appetitive and dietary responses than solid foods.

Detailed description: Three human studies are propsed to more fully characterized attributes of liquids and solids that may account for the differential appetitive responses they elicit, potential contributory mechanisms as well as the dietary implications of their consumption. Study 1 will contrast the acute effects of fluid and solid foods varying in macronutrient content on satiation, satiety and feeding. Study 2 will determine if the pattern of fluid and solid ingestion influences satiety and feeding by monitoring appetitive and dietary responses to energy and macronutrient matched fluid and solid loads ingested as meal components or between meal snacks. To better assess the clinical implications ofdiets incorpprating liquid or solid supplements. Study 3 will entail chronic ingestion of matched energy yeilding fluid or solid loads with concurrent measurement of appetite, dietary intake, energy expenditureand body weight/composition.

Eligibility: Inclusion Criteria:
  -  BMI 18-23 or 27-35
  -  weight stable
  -  constant habitual activity pattern
  -  low fruit/vegetable consumer
  -  non-restrained eater
  Exclusion Criteria:
  -  diabetic
  -  taking medication known to influence appetite

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Proton Beam Therapy for Chondrosarcoma

Summary: The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. The safety of this treatment will also be studied.

Detailed description: Patients who have skull base chondrosarcoma require complicated treatment because of its challenging location and nearness to critical structures within the brain.
  Pathology will be confirmed prior to discussion of the study.
  If you are found to be eligible to take part in this study, you will receive proton beam therapy, no sooner than 2 weeks after the last surgery to remove tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays, and holidays) at the Proton Center in Houston. The whole process should take up to 1 hour each day.
  If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy.
  After the proton beam, and possibly photon beam, therapy, you will be asked to come in for study follow-up visits every year, until the study is completed. At these visits, you will have magnetic resonance imaging (MRI) scans, blood draws (less than 1 teaspoon) to monitor your pituitary function, and neuropsychological testing. For the neuropsychological testing, you will be interviewed and tested by a neuropsychologist to evaluate your memory, fluency (the ability to talk and form words) complex thinking ability, planning ability, and coordination. These tests could last from 1-2 hours. You will also have eye exams performed by an ophthalmologist from MD Anderson and hearing exams. It is anticipated that it will take about 5 years to complete this study.
  This is an investigational study. The proton beam center and its treatment are approved by the FDA for patient use. A total of up to 15 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility: Inclusion Criteria:
  1. Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base
  2. Contrast enhanced postop MRI or CT if there is clinical contraindication for MRI of the skull base obtained with 90 days of study registration at M. D. Anderson
  3. The patient has been assessed by MDACC skull base surgeons to have undergone maximal surgical debulking of disease
  4. Karnofsky Performance status greater than or equal to 60
  5. Signed informed consent
  Exclusion Criteria:
  1. Previous irradiation of the skull base
  2. Documented evidence of disseminated metastatic disease

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells.
  PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.

Detailed description: OBJECTIVES:
  -  Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.
  OUTLINE: This is a pilot study.
  Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.
  Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.
  After completion of study therapy, patients are followed periodically for up to 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of epithelial solid tumors of any of the following sites or types:
  -  Lung (closed to accrual as of 4/2/2009)
  -  Renal
  -  Prostate
  -  Breast (closed to accrual as of 4/2/2009)
  -  Sarcoma (closed to accrual as of 4/2/2009)
  -  Colon (closed to accrual as of 4/2/2009)
  -  Liver(closed to accrual as of 4/2/2009)
  -  Pancreatic (closed to accrual as of 4/2/2009)
  -  Bone (closed to accrual as of 4/2/2009)
  -  Head and neck (closed to accrual as of 4/2/2009)
  -  Melanoma (closed to accrual as of 4/2/2009)
  -  Carcinoma of unknown primary (closed to accrual as of 4/2/2009)
  -  Advanced or metastatic disease
  -  Ineligible for or unwilling to undergo surgical resection
  -  Eligible for cryotherapy but not expected to be cured by cryotherapy alone
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Life expectancy > 3 months
  -  Creatinine < 2.5 mg/dL
  -  Platelet count >75,000/mm³
  -  INR< 1.5
  -  No known HIV positivity
  -  No active, uncontrolled infection
  -  Not pregnant
  -  Negative pregnancy test
  -  Women of childbearing potential must practice adequate contraception
  -  No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)

Summary: This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma. Up to 90 patients with confirmed chondrosarcoma will be enrolled.


Eligibility: Inclusion Criteria:
  -  Ability to understand and willingness to sign a written informed consent document
  -  Age ≥ 18 years
  -  Histologic diagnosis of chondrosarcoma, verifiable after enrollment
  -  Measurable disease
  -  Previously treated or incurable disease without options for standard of care therapy
  -  ECOG performance status of 0-2
  -  Life expectancy of > 3 months
  -  For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment
  Exclusion Criteria:
  -  Systemic therapy or radiotherapy within 4 weeks prior to Day 1
  -  Prior therapy with agents targeting the DR5 apoptosis pathway
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
  -  Other invasive malignancies within 5 years prior to Day 1
  -  Known active brain metastases
  -  Uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring parenteral antibiotics at enrollment
  -  Clinically significant, symptomatic cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade II or greater peripheral vascular disease, or history of major heart surgery within 6 months of Day 1, or any situation that would likely limit compliance with study requirements
  -  Known to be positive for hepatitis C or hepatitis B surface antigen
  -  History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
  -  Use of anticoagulation therapy
  -  Participation in clinical trials or undergoing other investigational procedures within 30 days prior to Day 1
  -  Pregnancy or breast feeding
  -  Known sensitivity to any of the products administered during the study
  -  Any disorder that compromises the ability of the patient to give written informed consent and/or comply with study procedures

Relevance to patient case: not relevant