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: Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation

Summary: The association between radiation exposure and cardiac disease is well recognized, it is not fully understood if there exists an optimal or "safe" radiation dose-volume relationship.

Detailed description: Identification of "safe" dose volume constraints (DVC) for the heart from breast cancer radiotherapy would permit maximal oncologic benefit from radiation, identifying which patients require more complicated and resource consumptive radiation methods such as respiratory-gating or intensity modulated radiotherapy (IMRT) and establish patients who need targeted follow-up for their long term cardiac risk. Two recent technical developments now make it conceivable to identify the dose-volume relationship between heart dose and subsequent cardiac event risk: 1. CT based three dimensional conformal radiation delivery methods (3DCRT) where the precise radiation dose to any given heart volume is known, and 2. Cardiac MRI (CMR) that is more sensitive to prior methods of cardiac evaluation (e.g. SPECT) for detecting and measuring cardiac injury.
  An MRI, subject health questionnaire, clinical and dosimetric data will be included in the analysis.

Eligibility: Inclusion Criteria:
  -  Women with node positive breast cancer treated with surgery, anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.
  Exclusion Criteria:
  -  Women who have not received anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.

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: Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer

Summary: Whether the patients with low grade ductal carcinoma in situ breast cancer should accept radiationtherapy is uncertain.Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Detailed description: Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Eligibility: Inclusion Criteria:
  -  Tumor diameter < 5 cm
  -  Low grade ductal carcinoma in situ
  -  Candidate for breast-conserving surgery
  -  Must have undergone lumpectomy with negative margins or minimal margin involvement
  -  Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
  -  No evidence of metastatic disease
  -  Informed consent
  Exclusion Criteria:
  -  No informed consent
  -  Tumor size > 5 cm
  -  Intermediate or high grade ductal carcinoma in situ
  -  Invasive carcinoma
  -  No indication for a boost

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: Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients

Summary: This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.


Eligibility: Inclusion Criteria:
  1. Male or female subjects aged 18 or older
  2. Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
  3. Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits
  Exclusion Criteria:
  1. Subjects who had topical treatment with corticosteroids within 1 week before randomization
  2. Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization
  3. Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening
  4. Subjects who participated in another drug trial within 4 weeks before screening

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: Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC

Summary: This study evaluates the performance of a blood test for detecting biomarkers in metastatic breast cancer patients at one clinic against standard testing.

Detailed description: The primary objective of this pilot study is to detect the expression of FGFR1 and AR on circulating tumor cells (CTCs) isolated from the peripheral blood of metastatic breast cancer (MBC) patients using the OncoCEE™ platform. No procedures will be associated with this study, as these mutations will be evaluated from the leftover blood that has already been sent for standard of care ER and HER2 using the same platform. Results from this testing will be correlated with results obtained from standard testing to calculate the rate of concordance between tests.

Eligibility: Inclusion Criteria:
  -  Current patient at participating clinic
  -  Metastatic breast cancer diagnosis
  -  18 years of age or older
  Exclusion Criteria:

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: Cardiac Toxicity in Medical Treatment of Breast Cancer

Summary: This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.
  In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.


Eligibility: Inclusion Criteria:
  -  Diagnosis of HER2 positive breast cancer
  -  Adjuvant treatment with trastuzumab
  Exclusion Criteria:
  -  Left ventricle ejection fraction (LVEF) <50%
  -  Chronic or persistent atrial fibrillation
  -  History of moderate or severe valvular heart 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: Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Summary: This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors .
  Everolimus 10 mg will be administered orally qd daily.
  To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. PIK3CA amplification, PTEN loss and PIK3CA mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
  7. Any previous treatment with everolimus

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

Clinical trial: Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors

Summary: This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors.
  This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.
  To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. RET fusion positive,FGFR amplification, Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. Any previous treatment with sunitinib

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

Clinical trial: Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors

Summary: This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors.
  This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.
  To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. FGFR2 amplification or FGFR2 mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. Any previous treatment with Pazopanib.

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

Clinical trial: Study of Exercise to Manage Distress During Breast Screening

Summary: The breast cancer screening and diagnostic period is associated with heightened symptoms of anxiety and depression. Physical exercise has been found to effectively decrease these symptoms in healthy and diseased populations. This study aims to determine if a pre treatment exercise intervention can minimize symptoms of anxiety and depression in women undergoing screening for breast cancer.

Detailed description: The breast cancer diagnostic process is associated with anxiety and depression. Physical exercise has emerged as an attractive non-pharmacologic approach to mitigating the psychological and physical sequelae of breast cancer and its treatments, however pre treatment interventions are not integrated into current practice. This study aims to determine the effectiveness and feasibility of a pre treatment exercise intervention in attenuating levels of anxiety and depression following breast biopsy and throughout the diagnostic period.

Eligibility: Inclusion Criteria:
  -  undergoing breast biopsy at St. Joseph's Health Care, London Ontario
  -  minimum BI-RADS 4a
  -  physically inactive
  Exclusion Criteria:
  -  meeting Health Canada Guidelines for Physical Activity for past 6 months
  -  medical contraindications to exercise
  -  unable to participate in moderate intensity exercise program

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: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Breast Cancer

Summary: The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Detailed description: By enrolling patients with breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Eligibility: Inclusion Criteria:
  1. Age:18-80
  2. Karnofsky performance status >60
  3. Diagnosis of breast cancer based on histology or the current accepted radiological measures.
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  5. Will receive interventional therapy
  6. Life expectancy: Greater than 3 months
  7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
  8. Ability to understand the study protocol and a willingness to sign a written informed consent document
  Exclusion Criteria:
  1. Patients with other primary tumor except breast cancer
  2. History of coagulation disorders or anemia

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: HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors

Summary: A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.

Detailed description: All human subjects with a diagnosis of incurable solid tumors are eligible for the dose-escalation phase of this study. This study consists of two phases, the dose-escalation phase and the expansion phase. Subjects will be treated with the study treatment until any off-treatment criteria are met. The safety and efficacy will be assessed until the end of treatment or for a maximum of 52 weeks. In addition, a separate visit will be performed at the time of disease progression if the patient has a progression between end of treatment and 52 weeks. The patients will be followed up for overall survival until the study closure. The study will be closed when all enrolled patients have been followed up for at least 52 weeks or have died.

Eligibility: Inclusion Criteria:
  -  Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
  -  Patients may have measurable or non-measurable but evaluable disease.
  -  Patients with surgically resected metastatic disease at high risk of relapse are also eligible.
  -  Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
  -  Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy
  -  Age ≥ 18 years. .
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).
  -  Patients must have normal organ and hematologic function therapy
  -  Patients must have baseline pulse oximetry > 90% on room air
  Exclusion Criteria:
  -  Pregnant women or women presently breast-feeding
  -  Concurrent treatment for cancer
  -  Chronic hepatitis B or C infection.
  -  Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
  -  Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  -  Active autoimmune diseases requiring treatment or a history of autoimmune disease.
  -  Concurrent use of systemic steroids
  -  Patients who are receiving any other investigational agents
  -  Patients with untreated central nervous system metastases or local treatment of brain metastases
  -  History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study.
  -  Serious or uncontrolled intercurrent illness
  -  HIV-positive patients are ineligible
  -  Patients unwilling to use adequate contraception
  Other protocol defined inclusion/exclusion criteria could 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: Study on Breast Cancer Patient Perspectives of Exercise

Summary: The goal of the study is to establish the feasibility/willingness of breast cancer patients to delay surgery to do an exercise program, or be randomized to an exercise training program following treatment, and to see if that willingness correlates with prior physical activity history.


Eligibility: Inclusion Criteria:
  -  women,
  -  breast cancer diagnosis,
  -  all races will be included.
  Exclusion Criteria:
  -  men,
  -  those with no breast cancer (ductal carcinoma in situ),
  -  pregnant women,
  -  children

Relevance to patient case: not relevant