araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

Summary: The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed breast adenocarcinoma.
  -  Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
  -  Prior first-line systemic therapy in the metastatic setting.
  -  Demonstrated progression of disease by radiological or clinical assessment.
  -  Female patient, aged ≥18 years old.
  -  Estimated life expectancy >3 months.
  -  Normal Left ventricular function
  -  Adequate haematological, hepatic and renal functions.
  -  For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
  -  Ability to swallow oral capsules or tablets.
  Exclusion Criteria:
  -  More than two lines of chemotherapy with or without targeted therapy in the metastatic setting.
  -  Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product.
  -  Active central nervous system metastases, cerebral oedema, and/or progressive growth.
  -  Patients with impaired cardiac function.
  -  Uncontrolled arterial hypertension
  -  Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
  -  Serum potassium level below Lower Limit of Normal
  -  Uncontrolled hypothyroidism.
  -  Pregnant or breastfeeding women.

Relevance to patient case: definitely relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Esmolol Effects on Heart and Inflammation in Septic Shock

Summary: Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the inflammatory response. Experimental works demonstrated that Esmolol, an highly selective beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono centric, double blind, randomized clinical work in septic shock patients has shown that Esmolol administration is safe and reduces effectively heart rate. However there are only sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human resuscitated septic shock patients treated by esmolol.


Eligibility: Inclusion Criteria:
  -  septic shock patients following the definition of the Surviving Sepsis Campaign
  -  femoral and central venous catheters for thermodilution monitoring
  -  fluid optimization
  -  with a cardiac index > 3 l/min/m2
  -  Heart Rate >100 /min
  Exclusion Criteria:
  -  Cardiogenic shock
  -  Bradycardia
  -  History of Severe Asthma
  -  Indications against esmolol

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Breast Cancer During Pregnancy

Summary: Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.


Eligibility: Inclusion Criteria:
  -  Patients with breast cancer diagnosed during pregnancy
  Exclusion Criteria:
  -  Patients who refuse informed consent

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Breast Cancer Tumor Heterogeneity

Summary: Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.


Eligibility: Inclusion Criteria:
  1. Women > age 18 with capacity to consent
  2. Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
  3. IHC biomarkers performed on original CNB (including HER2)
  4. Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
  5. Multifocal or multicentric tumors
  Exclusion Criteria:
  1. Men
  2. Women with HER2 positive tumors detected on CNB specimens
  3. Women receiving neoadjuvant chemotherapy
  4. Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
  5. Women whose IHC marker results were inconclusive on CNB or not performed -

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations

Summary: The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.

Detailed description: Lucitanib is an oral inhibitor of the tyrosine kinase activity of FGFR 1-3, VEGFR 1-3, and PDGFR α/β. Lucitanib has demonstrated potent anti-tumor and anti-angiogenic activity in vitro proliferation assays and in vivo using human tumor xenograft models, with a trend for stronger efficacy in those with genomic aberrancies of FGF or PDGF. Abnormalities in the FGF, VEGF, and PDGF-related genes are observed across lung cancer histologies.
  The first in human trial of lucitanib demonstrated that daily lucitanib is clinically active in patients with advanced solid tumors. Specifically, patients with FGFR1-amplification appeared to derive particular benefit from lucitanib.
  Based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in lung cancer patients with FGF, VEGF, and PDGF genetic alterations.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
  -  Any of the following tumor tissue based genetic alterations: FGFR1, FGFR2, FGFR3, VEGFA, or PDGFRα amplification; Any FGFR1, FGFR2, or FGFR3 gene fusion; FGFR1, FGFR2, or FGFR3 activating mutation
  -  Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
  -  Eastern Cooperative Oncology Group (ECOG) of 0 or 1
  -  Measurable disease per RECIST 1.1
  -  Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
  Exclusion Criteria:
  -  Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
  -  Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
  -  Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
  -  Symptomatic and/or untreated central nervous system metastases
  -  Presence of another active cancer
  -  Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
  -  Pregnant or breastfeeding women

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Integrating Palliative Care Into Self-Management of Breast Cancer

Summary: The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.


Eligibility: Inclusion Criteria:
  -  Over the age of 21
  -  Stage I-IV breast cancer
  -  Live in the State of Connecticut
  -  Speak English
  -  Receiving any kind of treatment for breast cancer
  -  Prognosis of at least 6 months

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Testing BRCA 1/2 Mutation Using Next Generation Sequencing

Summary: Testing BRCA 1/2 mutation is important for patients with breast cancer, and Sanger sequencing is a standard method to identify BRCA 1/2 mutation. Next generation sequencing (NGS) is a high-throughput parallel sequencing that can provide genetic information with high accuracy. NGS is a faster and cost-effective method to detect gene mutations compared to Sanger sequencing. In this study, we evaluated the clinical role of NGS testing for BRCA 1/2 compared to Sanger sequencing.


Eligibility: Inclusion Criteria:
  -  Age > 18
  -  Breast or ovarian cancer history in 2nd degree family members
  -  Male breast cancer
  -  Bilateral breast cancer
  -  Patient with breast cancer under 40 year of age
  -  Simultaneous breast and ovarian cancer
  -  Patients with epithelial ovarian cancer
  -  Breast cancer with other simultaneous extramammary malignancy
  Exclusion Criteria:
  -Patients who do not agree with testing BRCA 1/2 mutation

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

Summary: This study will evaluate the efficacy and safety of ALKS 5461.


Eligibility: Inclusion Criteria:
  -  Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
  -  Agree to use an acceptable method of contraception for the duration of the study
  -  Have a Major Depressive Disorder (MDD) primary diagnosis
  -  Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
  -  Additional criteria may apply
  Exclusion Criteria:
  -  Have a current primary Axis-I disorder other than MDD
  -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
  -  Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
  -  Have attempted suicide within the past 2 years
  -  Have a positive test for drugs of abuse
  -  Are pregnant, planning to become pregnant, or breastfeeding
  -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
  -  Have had a significant blood loss or blood donation within 60 days
  -  Additional criteria may apply

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

Summary: This study will evaluate the efficacy and safety of ALKS 5461.


Eligibility: Inclusion Criteria:
  -  Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
  -  Agree to use an acceptable method of contraception for the duration of the study
  -  Have a Major Depressive Disorder (MDD) primary diagnosis
  -  Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
  -  Additional criteria may apply
  Exclusion Criteria:
  -  Have a current primary Axis-I disorder other than MDD
  -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
  -  Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
  -  Have attempted suicide within the past 2 years
  -  Have a positive test for drugs of abuse
  -  Are pregnant, planning to become pregnant, or breastfeeding
  -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
  -  Have had a significant blood loss or blood donation within 60 days
  -  Additional criteria may apply

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

Summary: This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.


Eligibility: Inclusion Criteria:
  -  Patient who has histologically confirmed and newly diagnosed breast cancer
  -  Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC (American Joint Committee on Cancer) Breast Cancer Staging 7th edition
  -  Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry).
  Exclusion Criteria:
  -  Patient who has bilateral breast cancer
  -  Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

Summary: This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.


Eligibility: Inclusion Criteria:
  -  Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
  -  Measurable disease, according to the RECIST v1.1
  -  Adequate hematologic and organ function within 14 days before the first study treatment
  -  For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment
  Exclusion Criteria:
  -  Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent
  -  Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
  -  Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer
  -  Previous therapy with Akt, PI3K, and/or mTOR inhibitors
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
  -  Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Registry for Pulmonary Hypertension Due to Left Heart Disease in China

Summary: Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging society, chronic heart failure has become a global public health problem. Therefore the prevalence of pulmonary hypertension due to the left heart disease is increasing. However, there is no research on the prevalence of pulmonary hypertension due to the left heart disease in China. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary hypertension due to the left heart disease and identify factors that may predict outcome. Our study will profile the demographics, clinical course, treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.


Eligibility: Inclusion Criteria:
  -  Pulmonary Hypertension due to left heart disease
  Exclusion Criteria:
  -  Other forms of Pulmonary Hypertension
  -  Heart failure due to valvular heart disease
  -  Hypertrophic obstructive cardiomyopathy
  -  Right ventricular outflow tract stenosis
  -  Pericardial disease
  -  Patients with chronic lung disease

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

Summary: The purpose of this signal seeking study is to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility: Inclusion Criteria:
  -  Patient has a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative will be included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).
  -  Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation
  -  Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  -  Patient has progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  Exclusion Criteria:
  -  Patients has received prior treatment with LEE011.
  -  Patient has clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
  -  Patients has primary CNS tumor or CNS tumor involvement
  -  Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Relevance to patient case: not relevant