araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

Summary: Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.


Eligibility: Inclusion Criteria:
  -  Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH)
  -  Visceral metastasis, only or multiple
  -  First line metastasis treatment by Trastuzumab in association with chemotherapy
  -  Good general conditions: OMS=<2 or Karnofsky >=70%
  -  Age > 18 years and < 70 years
  -  Life expectancy >=3 mois
  -  No Trastuzumab since more of 6 months
  -  No cerebral metastasis (MRI)
  -  Efficacy contraception for women with genital capacities
  -  Consent signed by the patient
  Exclusion Criteria
  -  Contraindication to IRM
  -  Psychiatric decease
  -  Prior cerebral radiotherapy,
  -  Geographical constraint, compromising the fallow of patients
  -  Infectious or other serious pathology, likely to stop the treatment
  -  Positive serology (HIV, hBC, hBS)
  -  Inclusion in an other clinical trial or in the 4 weeks before th inclusion
  -  Pregnant or breastfeeding women

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Summary: Selected 400 cases of women with primary breast cancer who were treated with operation randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Detailed description: The investigators selected 400 cases of women with primary breast cancer who were treated with operation randomly,then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Eligibility: Inclusion Criteria:
  1. Provision of informed consent
  2. Pathological confirmation of breast cancer
  3. Tumor stage(TNM):T2-4bN0-3M0
  4. ER(+) and/or PR(+).
  5. Premenopausal woman.
  6. Age≥40 years
  7. Measurable disease as per RECIST criteria
  8. Karnofsky≥70
  9. Laboratory criteria:
  -  PLT≥100*109/L
  -  WBC≥4000/mm3
  -  HGB≥10g/dl
  -  ALT and AST<2*ULN
  Exclusion Criteria:
  1. Presence of metastatic disease.
  2. Inflammatory breast cancer.
  3. Bilateral breast cancer.
  4. previous chemotherapy or hormonal therapy for current breast neoplasm.
  5. other malignant tumor (concurrent or previous).
  6. Pregnant woman.
  7. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
  8. Any severe systemic disease contraindicating chemotherapy.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer

Summary: This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.
  The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed invasive breast carcinoma
  -  Stage T1-3,N0 evaluated by physical exam or imaging according to AJCC v.7 and best clinical local practices
  -  Intraoperative evaluation of sentinel lymph node (SLN) by OSNA
  -  Complete dissection of axillary lymph nodes after the evaluation of the SLNs by OSNA
  -  Pathology report of the tumor and dissected lymph nodes that includes the following information:
  -  primary tumor size (mm), tumor grade (Scarff-Bloom Richardson), estrogen receptor status
  -  progesterone receptor status
  -  HER2 status (ASCO/CAP guidelines)
  -  Ki67 index
  -  presence/absence of lymphovascular invasion
  -  total number of sentinel and non-sentinel lymph nodes dissected during surgery
  -  total number of positive and negative sentinel and non-sentinel lymph nodes, *size of the metastasis in both sentinel and non-sentinel lymph nodes
  -  total tumoral load in each sentinel lymph node, expressed as number of CK19 mRNA copies per microliter.
  Exclusion Criteria:
  -  Patients who underwent neoadjuvant chemotherapy
  -  CK19-negative breast tumor
  -  ALND with <10 lymph nodes
  -  In situ carcinoma only
  -  Metastatic breast cancer at time of diagnosis

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma

Summary: First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

Detailed description: Study Design: This is an open-label, dose exploration study evaluating AMG 232 in subjects with advanced p53WT solid tumors or multiple myeloma. The study will be conducted in 2 parts: Part 1 - Dose Exploration (parts 1a, 1b and 1c) and Part 2 - Dose Expansion. Part 1a is aimed at evaluating the safety, tolerability, PK and PD of AMG 232 and determining the MTD of a 7-day once daily (QD) dosing schedule in subjects with advanced solid tumors using a practical continuous reassessment method (CRM). Part 1b will evaluate the safety and tolerability of 3-day QD dosing schedule (or alternate dosing schedule based upon emerging data) with a particular emphasis on evaluating the tolerability of daily doses equal to or higher than the part 1a MTD in subjects with solid tumors or multiple myeloma. Part 1c will evaluate the safety and tolerability of 7-day twice daily (BID) dosing schedule with daily cumulative doses equal to or higher than the part 1a MTD in subjects with solid tumors. The dose expansion part of the study (Part 2) can open once the MTD has been determined in Part 1a. Part 2, part 1b and part 1c can be explored in parallel. The dose expansion part will consist of up to 85 additional subjects with specific tumors harboring MDM2 amplification (liposarcoma [LPS], gliobastoma [ GBM ] and all other solid tumors) or potentially harboring MDM2 overexpression (ER+ metastatic breast cancer) and a group of subjects with multiple myeloma.

Eligibility: Inclusion Criteria:
  -  Men or women > 18 years old
  -  Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma
  -  Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.
  -  Ability to take oral medications and willing to record daily adherance to investigational product
  -  Adequate hematological, renal, hepatic, and coagulation laboratory assessments
  Exclusion Criteria:
  -  Active brain metastases
  -  For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years
  -  Active infection requiring intravenous (IV) antibiotics
  -  Anti-tumor therapy
  -  Therapeutic or palliative radiation therapy within 30 days of starting treatment
  -  Currently enrolled in another investigational device or drug study

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer

Summary: Breast cancer is a heterogeneous disease and can be classified into several distinctive subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER), progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2) overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its aggressive clinical behavior and insensitivity toward available targeted treatment strategies such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early relapse with metastatic disease is common and the prognosis is poor. Development Of novel treatment strategies is,therefore,needed and the study of other potential targets in TNBC,like tyrosine kinase receptors,is a topic of interest.
  Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR mutation was rare in TNBC.
  By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one or more limitations including:1) the study population had received heavily pretreatment; 2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR was not clear in the enrolled patients.
  Here, the investigators launch a prospective clinical trial, and about 50 patients with triple-negative,EGFR positive metastatic breast cancer that have received at least second line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in the metastatic TNBC.


Eligibility: Inclusion Criteria:
  -  ≥18 years of age
  -  ≥1 measurable or assessable lesion
  -  Eastern Cooperative Oncology Group(ECOG)performance status of 0-2
  -  adequate renal,hepatic and hematological function
  -  a life expectancy of >12 weeks
  -  histologically proven EGFR positive metastatic TNBC
  Exclusion Criteria:
  -  brain metastasis

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Light-Scattering Spectroscopy for Detection of Breast Cancer

Summary: This pilot clinical trial studies light-scattering spectroscopy in finding disease in patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering spectroscopy, may help find and diagnose breast cancer

Detailed description: PRIMARY OBJECTIVES: I. To evaluate whether light-scattering spectroscopy can reliably distinguish between two subject groups: those with clinical stage II or stage III breast cancer and those without breast cancer.
  OUTLINE: Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.

Eligibility: Inclusion Criteria:
  -  Participants who are breast cancer free (mammogram "negative" within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with clinical stage II or stage III breast cancer. PLEASE NOTE: Recruitment for this study is only limited to patients who are scheduled for a mammogram at USC. There is no compensation to participants.
  -  Provision of informed consent prior to any study-related procedures
  Exclusion Criteria:
  -  Females with tattoos on either or both breasts
  -  Females with nipple piercings on either or both breasts
  -  Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts
  -  Females unable to provide informed consent
  -  Females s/p treatment for breast cancer

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Non-Interventional Study of the Occurrence Rate of Non-Small Cell Lung Cancer, Colon Cancer, Breast Cancer, Gastric Cancer and Malignant Melanoma in Turkey, and Diagnosis and Treatment Characteristics

Summary: This non-interventional study will assess the occurrence rate of non-small cell lung cancer, colon cancer, breast cancer, gastric cancer and malignant melanoma in Turkey, and the diagnostic methods and treatments used. Data will be collected over 36 months.


Eligibility: Inclusion Criteria:
  -  Participants diagnosed with non-small cell lung, colon, breast, gastric cancer and melanoma
  -  Participants who give consent to the collection of their information after the first record and pathological confirmation of their cancer
  Exclusion Criteria:
  -  Participants not living in the city or representative region of the study center

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Clinical Value of 89Zr-trastuzumab PET

Summary: Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool.
  In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.


Eligibility: Inclusion Criteria:
  1. Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:
  -  HER2 immunohistochemical score of 3+, or
  -  HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
  In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification.
  2. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
  -  in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and
  -  in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
  3. Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET.
  4. Age >18 years of age.
  5. WHO performance status 0-2.
  6. Signed written informed consent.
  7. Able to comply with the protocol.
  Exclusion Criteria:
  1. Pregnant or lactating women.
  2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
  3. Inability to comply with study procedures

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Once-Daily Oral Dose of BeneFlax to Healthy Older Adults

Summary: The investigators are investigating whether the flax lignan, secoisolariciresinol diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to be broken down in the body to produce the health benefits of flax. Flax lignan is separated from the whole flax seed as this compound is believed to have health effects. Decreasing oxidative stress and inflammation should improve a number of the problems associated with aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an equivalent amount of whey protein.
  The investigators are comparing lignan to a placebo (whey powder) to examine whether a dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and inflammation.


Eligibility: Inclusion Criteria:
  -  Male or female adult 60 to 80 years residing in Saskatoon.
  -  Able to comply with study protocol.
  -  Able to follow simple instructions.
  Exclusion Criteria:
  -  Age below 60 or above 80 years at initiation of the study.
  -  Individuals living in long term care homes.
  -  Individuals at risk of hypotension or with symptomatic hypotension.
  -  Fasting hypoglycemia.
  -  Unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study).
  -  Current cancer or diagnosed with cancer in the past 2 years.
  -  Women with an immediate family history or personal history of breast cancer or ovarian cancer.
  -  Significant liver or other gastrointestinal disorder including inflammatory bowel disease. (While constipation is the most common gastrointestinal problem in the elderly, it would not be a contraindication)
  -  Significant kidney disorder.
  -  Unstable or severe cardiac disease, recent myocardial infarction or stroke (either in past 6 months or significantly affecting physical mobility).
  -  Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
  -  Migraine with aura within the last year (as this is a risk factor for stroke).
  -  Current diagnosis of a bleeding condition, or at risk of bleeding.
  -  Significant immunocompromise.
  -  Other unstable conditions.
  -  Current use of hormone replacement therapy (except thyroid medication is allowed).
  -  Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
  -  Intolerances or allergies to flax or vitamin D.
  -  Allergy to whey
  -  Surgery within the last six months.
  -  Participation in any other clinical trial with an investigational agent within one month prior to randomization.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors

Summary: This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

Detailed description: This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.

Eligibility: Inclusion Criteria:
  1. Patients with the following indications:
  i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
  -  For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
  -  For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
  2. ECOG Performance Status of 0-2
  3. Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
  4. Willingness and ability to comply with all study procedures
  5. Written informed consent obtained prior to any screening procedures
  6. During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Johns Hopkins Breast Cancer Program Longitudinal Repository

Summary: The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators affiliated with it - to develop a repository of specimens with corresponding characteristics from patients seen in the breast care and cancer clinics.

Detailed description: This research is being done to collect samples for future use that we may learn more about cancer by studying cells in blood and tissue collected from people with breast cancer as well as from volunteers without breast cancer. Our goal is to make these available for research to help to learn how cancer develops and how it may be treated.

Eligibility: Inclusion Criteria:
  -  Male or female
  -  18 years of age or older
  -  Participants meet one of the following categories: have a known diagnosis of breast cancer receiving a breast cancer evaluation and/or treatment; have benign breast disease receiving a diagnostic procedure and/or evaluation; or, have no known diagnosis of breast disease or abnormality and is undergoing routine screening or diagnostic breast imaging procedures and/or other clinical evaluation.
  Exclusion Criteria:
  -  N/A

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Neratinib HER Mutation Basket Study (SUMMIT)

Summary: This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti-cancer therapy.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  -  Pediatric patients (at least 12 but less than 18 years of age at signing of informed consent) may be recruited in the Fibrolamellar Carcinoma cohort.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER tyrosine kinase inhibitor (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Relevance to patient case: not relevant