araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Risk Stratification of Nodal PTCL

Summary: This study is to investigate the prognostic significance of enhanced International Prognostic Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL patients.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative)
  -  Patients diagnosed with between January 1, 2004 and April 30, 2016
  -  initially treated with curative intent
  -  Patients with standard 18F-fluorodeoxyglucose (FDG) PET or PET-CT data at the time of diagnosis and at the end of primary treatment
  Exclusion Criteria:
  -  Patients diagnosed with extranodal PTCLs, including followings (extranodal NK/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; EBV-positive T-cell lymphoproliferative childhood disorders, and primary cutaneous lymphomas)
  -  Patients with ALCL-ALK+
  -  Patients who do not have 18F-FDG PET or PET-CT data either at diagnosis or at the end of treatment available for review

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in NHL Patients

Summary: The purpose of this study is to evaluate the effectiveness of circulating DNA from peripheral blood for predicting the prognosis and relapse in DLBCL and PTCL patients.

Detailed description: The investigators plan to prospectively involve 300 Non-hodgkin Lymphoma patients, including both diffuse large B cell lymphomas and peripheral T cell lymphomas without previous treatment from Peking Union Medical College Hospital.
  The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number and type of involved sites, prognostic index including International Prognostic Index (IPI) for DLBCLand PIT for PTCL based on medical record review.
  All patients would have regular treatment and follow up in PUMCH. During the follow up, treatment response was evaluated by contrast enhanced computed tomography or PET-CT.
  The peripheral blood would be collected and circulating DNA would be tested at the time of diagnosis, interim of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up, 3 year of follow-up and disease progression or relapse. TCR/BCR domain would be sequenced by high-throughput sequencing.

Eligibility: Inclusion Criteria:
  1. pathologically confirmed diffuse large B cell lymphoma (DLBCL nos, PCNSL, ALK+ DLBCL, DLBCL/BL) or peripheral T cell lymphoma (AITL, ALCL, PTCL nos, NK/T nasal type, EATL, HSTL)
  2. no treatment before
  3. hCG(-)
  4. 18 years old to 80 years old
  Exclusion Criteria:
  1. other tumors
  2. severe infections

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Establishment of Normal Breast Epithelial Cell Lines From Patients at High Risk for Breast Cancer

Summary: Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.

Detailed description: Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.

Eligibility: Women at high risk for breast cancer, either because they are a member of a high risk breast or ovarian cancer family, or because of a carcinoma of the opposite breast.
  Normal mammogram within past 3 months.
  No suspicious breast or axillary lesions on physical examination.
  No major cardiopulmonary, hepatic or renal disorders.

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

Summary: This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.


Eligibility: Inclusion Criteria:
  -  postmenopausal women;
  -  metastatic breast cancer suitable for endocrine therapy;
  -  positive hormone receptor status;
  -  Human epidermal growth factor receptor 2 (HER2) overexpression.
  Exclusion Criteria:
  -  patients on hormone replacement therapy;
  -  previous chemotherapy for metastatic disease;
  -  uncontrolled cardiac disease and history of cardiac failure.

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: GW572016 For Treatment Of Refractory Metastatic Breast Cancer

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


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

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
  PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.


Eligibility: Inclusion Criteria:
  -  Confirmed infiltrating adenocarcinoma of the breast
  -  Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
  -  No prior radiation to the involved breast
  -  ECOG (Electrocochleography) performance status 0-2
  -  Age 18 years to 80 years
  -  Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl
  -  All liver function tests < upper limit of normal
  -  Serum creatinine < 2.0 mg/dl
  -  Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated Acquisition) scan or echocardiogram
  -  HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test. [FISH (+) is HER-2/neu (+)]
  -  If female of childbearing potential, pregnancy test is negative
  -  If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study
  -  Informed consent has been obtained
  Exclusion Criteria:
  -  Non-confirmed infiltrating adenocarcinoma breast cancer
  -  Evidence of metastasis
  -  Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin
  -  Prior radiation to the involved breast
  -  Recent breast cancer drug therapy within last 5 years of any form
  -  History of allergy to polysorbate or castor oil
  -  Ongoing active infection
  -  Concurrent life-limiting disease with a life expectancy of less than one year
  -  Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix
  -  Pregnancy, nursing, fertile women who do not use birth control device
  -  Inability to give informed consent
  -  Patients with pre-existing peripheral neuropathy > grade 2

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Summary: The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Signed Informed Consent
  -  Able to swallow an oral medication
  -  Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
  -  Adequate kidney and liver function
  -  Adequate bone marrow function
  -  Tumor tissue available for testing
  -  Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
  -  No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
  Exclusion criteria:
  -  Prior treatment regimens for advanced or metastatic breast cancer.
  -  Pregnant or lactating
  -  Conditions that would effect the absorption of an oral drug
  -  Active infection
  -  Brain metastases
  -  Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
  -  Known hypersensitivity to Taxol or excipients of Taxol
  -  Peripheral neuropathy of Grade 2 or greater is not permitted
  -  Severe Cardiovascular disease or cardiac disease requiring a device.
  -  Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Summary: This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  -  Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
  -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
  -  Adequate renal, hepatic and cardiac function
  Exclusion criteria:
  -  Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
  -  Patients with active brain metastases
  -  Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: A Study of Patients With HER2-Positive Metastatic Breast Cancer

Summary: This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.


Eligibility: Inclusion Criteria:
  -  Signed Informed Consent document (unless the IRB has granted a waiver of consent)
  -  Signed Authorization for the Use and Disclosure of Health Information document
  -  HER2-positive breast cancer
  -  Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment
  -  Availability of cancer-specific historical data points in the patient's medical records
  Exclusion Criteria:
  -  There are no exclusion criteria for participation in this trial

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

Summary: This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.


Eligibility: Inclusion criteria:
  -  Tumor accessible for multiple biopsies
  -  ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  -  Adequate bone marrow
  -  Renal and hepatic function
  -  LVEF (left ventricular ejection fraction) greater than 0% based on ECHO (echocardiogram) or MUGA (multigated acquisition).
  Exclusion criteria:
  -  Females who are pregnant or nursing.
  -  Any unstable, pre-existing major medical condition.
  -  Received an investigational drug within the past 4 weeks.
  -  Had major surgery in the past 2 weeks.
  -  Currently receiving amiodarone or has received amiodarone in the past 6 months.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Primary Progesterone Therapy for Operable Breast Cancer

Summary: The purpose of this study is to test the effect of primary progesterone on overall and disease free survival in women with operable breast cancer. The study addresses two issues related to breast cancer surgery:
  -  Circulating progesterone at the time of surgery might counteract the detrimental effect of estrogen on survival of women with operable breast cancer.
  -  Events at the time of surgery may have an impact on the natural history of breast cancer

Detailed description: This protocol addresses the issue of pre-operative hormone manipulation in women with operable breast cancer. The study has been designed after careful review of literature to assess the effect of unopposed oestrogen at the time of surgery and collect evidence that events at the time of surgery may have impact on the long-term survival of breast cancer patients. The meta-analysis of 37 studies on timing of surgery during the menstrual cycle showed a 15% + 3 improvement in survival for women who had undergone surgery during the luteal phase of their menstrual cycle. Three of the 37 studies where progesterone levels were estimated at the time of surgery showed 52% + 26 improvement in survival when circulating progesterone were > 1.5 ng/ml. The study aims to produce luteal milieu by injecting Hydroxy- progesterone 500 mg IM at the time of surgery. The timing of administration of progesterone in the neo-adjuvant setting is decided after collating data from large data-bases and randomised trials of screening suggesting that events at the time of surgery may alter the behavior of micro-metastases.

Eligibility: Inclusion Criteria:
  -  Unilateral operable palpable breast cancer
  Exclusion Criteria:
  -  Previous history of excision biopsy of the primary tumour
  -  History of other epithelial/mesenchymal malignant tumours except basal cell carcinoma/squamous cell carcinoma (BCC/SCC) of skin

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Mistletoe Extract in Early or Advanced Breast Cancer, A Feasibility Study

Summary: The purpose of this feasibility study is to identify appropriate surrogate parameters for a randomized study to examine the efficacy of a complementary therapy with an extract of viscum album (Iscador P) in patients with breast cancer.

Detailed description: The study consists of three parts. Part 1 is a prospective non-randomized feasibility study in patients with breast cancer after primary surgery during chemotherapy or endocrine therapy comparing blood count, lymphocytes, quality of life and local and general side effects between the groups Part 2 is a prospective randomized feasibility study with a waiting list for three months comparing changes in quality of life, depression, diurnal cortisol profile and expression of zeta-chains in T- and NK-cells after three months of treatment or waiting in patients of two different strata (early breast cancer UICC I/II and metastatic breast cancer) Part 3 consists of two follow-up periods of 12 months respective. Patients may choose to continue, quit or restart mistletoe treatment upon their own decision, endpoints from part 2 are evaluated every 6 months.

Eligibility: Inclusion Criteria:
  -  breast cancer
  -  desire for additional therapy with mistletoe extracts
  Exclusion Criteria:
  -  contraindication for a therapy with mistletoe extracts(allergy, tuberculosis, hyperthyreosis, acute infectious disease, intracranial pressure in case of tumors or metastasis)
  -  current medication with glucocorticoids or other immunosuppressive therapies
  -  other concomitant complementary therapies
  -  prior therapy with mistletoe extracts > 2 years or during the last 6 months
  -  karnofsky-Index <60

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Summary: Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.


Eligibility: Inclusion criteria:
  -  Signed Informed Consent
  -  ErbB2(HER2)overexpressing breast cancer.
  -  Brain lesion(s) which are progressing.
  -  Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).
  -  Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.
  -  Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.
  -  Able to swallow an oral medication.
  -  Adequate kidney and liver function.
  -  Adequate bone marrow function.
  Exclusion criteria:
  -  Pregnant or lactating females.
  -  Conditions that would effect the absorption of an oral drug.
  -  History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
  -  Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
  -  Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Relevance to patient case: definitely relevant