araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Bergonie Institute Breast Cancer Database

Summary: A database of breast cancer patients was established at Institute Bergonié since the 90s , to assess patients' survival, assess practice, search for prognostic factors.


Eligibility: Inclusion Criteria:
  -  Breast cancer
  -  Aged 18 years and over
  -  First treatment at Bergonie Institute
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: The Study on the Clinical Utility of Liquid Biopsy in Breast Cancer

Summary: Through this prospective clinical trial,the investigators will focus on the relationship between circulating tumor biomarkers (i.e. circulating tumor cells, circulating tumor DNA and other biomarkers) and the status of primary tumor to discuss its application for assessing prognosis and individualized therapeutic direction. Moreover, the relationship between the circulating tumor cell subpopulations based on epithelial-mesenchymal transition and molecular pathological classification of breast cancer will be determined, which may enable the determination of the value of its application in therapeutic decision making.


Eligibility: Inclusion Criteria:
  -  Female patients aged ≥18 years with histologically confirmed breast cancer.
  -  The patients diagnosed with breast cancer for the first time, including postoperative patients within one month and the patients diagnosed with Stage IV breast cancer for the first time.
  Exclusion Criteria:
  -  The patients who has begun medication for breast cancer.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: New Approaches for the Identification and Characterization of Functional Markers of the Risk of Extension of Breast Cancer Without Lymph Node Involvement

Summary: 1. Identify the tissue proteins associated with early breast cancer invasion phases without lymph node involvement .
  2. Consider their role in the invasion and the risk of tumor spread .


Eligibility: Inclusion Criteria:
  -  Breast cancer
  -  CCIS
  -  Invasive tumors
  -  Breast cancer tissues available in the biobank
  Exclusion Criteria:
  -  non availability of cancer tissue specimen

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.

Summary: The purpose of this study was to evaluate whether treatment with pioglitazone is associated with risk of incident cancer at the 10 most common sites in a cohort of participants with recognized diabetes.

Detailed description: The study enroll a large population of approximately 252467 participants. The study would analyze association of cancer and pioglitazone in 2 cohorts based on the usage of pioglitazone. Participants in were originally planned to be followed-up from January 1, 1997 to December 31, 2005. Based on the discussion with advisory board, it was recommended to increase the study population and duration of follow-up. The follow-up period was extended to June 30, 2012 for the study.
  This multi-center trial was conducted in the United States of America. The overall time to participate in this study was approximately 15.5 years. Participants were followed-up from January 1, 1997 up to June 30, 2012 for the assessment of cancer risk associated with pioglitazone use.

Eligibility: Inclusion Criteria:
  1. has been in the KPNC diabetes registry Diabetes Mellitus (DM) registry, aged 40 years or older and are members of KPNC as of January 1, 1997, or
  2. has been in the DM registry, reached aged 40 years between January 1, 1997 and June 30, 2005 and are KPNC members on their 40th birthday, or
  3. has joined KPNC after January 1, 1997, aged 40 years or older when they are identified by the DM registry between January 1, 1997 and June 30, 2005.
  Exclusion Criteria: 1. Age less than (<) 40 years during study period. 2. No KPNC medication benefits at the time of entry into the cohort (baseline) or gap in medication benefit greater than equal to (>=) 4 months that started in the first 4 months after entering in the cohort.
  3. Gap in KPNC membership >= 4 months that started in the first 4 months after entering in the cohort.
  4. Participant with a diagnosis of Human immunodeficiency virus (HIV). 5. Participants with evidence of selected surgeries for some cancer sites. 6. All prevalent cancers at baseline, that is, all participants ever diagnosed with cancer other than non-melanoma skin cancer.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Adapted Physical Activity for Breast Cancer HER2 Positive Patient

Summary: The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.

Detailed description: After the assessment of their physical fitness, a home-based adapted physical activity program composed by aerobic and muscle strengthening exercises will be delivered to each patient. The aim of the intervention is to reach international recommendation in a progressive way during neoadjuvant chemotherapy.

Eligibility: Inclusion Criteria:
  -  Women > 18 years old
  -  Patient with HER2 (Human Epidermal growth factor Receptor 2) positive breast cancer histologically proven, eligible for neoadjuvant chemotherapy and targeted therapy against HER-2
  -  Affiliation to the French social security scheme
  -  Patient who signed the participation consent before entering the trial
  -  Medical fitness certificate for sport
  Exclusion Criteria:
  -  Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer
  -  Metastatic cancer
  -  Karnofsky index ≤ 90%
  -  Men
  -  Pregnant women
  -  Significant psychiatric or neurological abnormality
  -  Patient deprived of liberty by a court or administrative
  -  Contraindication for physical activity
  -  Patient unable to complete questionnaires (language barrier)
  -  Participation in a clinical trial with the same objective

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma

Summary: The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Unresectable stage III or stage IV melanoma which is histologically confirmed at the treating institution with KIT mutation(s) not known to be resistant to PLX3397
  -  Presence of measurable lesions by Response Evaluation Criteria in Solid Tumors
  -  Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2
  -  Life expectancy ≥ 3 months
  -  Adequate organ and bone marrow function
  -  Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile.
  -  Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug.
  -  Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements
  Exclusion Criteria:
  -  Prior treatment with a KIT inhibitor for melanoma
  -  Presence of NRAS or BRAF mutation
  -  Exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy
  -  Symptomatic brain metastases.
  -  Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor
  -  Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
  -  Uncontrolled intercurrent or infectious illness
  -  Major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study
  -  Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry
  -  Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption
  -  Congestive heart failure (CHF) New York (NY) Heart Association class III or IV; unstable coronary artery disease (myocardial infarction [MI] more than 6 months prior to study entry is permitted); or serious cardiac arrhythmia
  -  Baseline QTcF ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening
  -  Active or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
  -  Known chronic liver disease
  -  Women who are breast-feeding or pregnant

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer

Summary: This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer.

Detailed description: Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective option for ER-positive, HER2-negative breast cancer patients. However this is still a controversial issue. The present study is an open-label randomized controlled clinical trial that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.

Eligibility: Inclusion Criteria:
  1. Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc.
  2. Without previous chemotherapy or endocrine therapy.
  3. ECOG scores of 0-2 points
  4. With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma
  5. Age: 18-70 years
  6. Lateral breast cancer
  7. Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions
  Exclusion Criteria:
  1. Pregnant women or nursing mothers
  2. With distant metastasis
  3. With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years
  4. With mental illness or other conditions affecting the patient compliance
  5. With other serious diseases or medical conditions:
  1. Congestive heart failure or unstable angina pectoris, myocardial infarction within 6 months before the enrollment, uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator
  2. Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases may affect the understanding and sign of the informed consent for
  3. Uncontrolled acute infection
  6. Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study
  7. With allergic constitution and any known or suspected drug allergy
  8. Not suitable for the trial considered by the investigator

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Trastuzumab Based Therapy in HER2 Positive AGC

Summary: Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. The object of the study is to determine whether the addition of trastuzumab to first-line chemotherapy improves efficacy compared with chemotherapy alone in HER2 positive AGC.

Detailed description: A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational study. All patients were treated with trastuzumab plus chemotherapy as the first line therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Eligibility: Inclusion Criteria:
  1. pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;
  2. received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;
  3. with measurable lesion with a diameter 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;
  4. Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;
  5. left ventricular ejection fraction(LVEF) more than 50 percents;
  6. sufficient bone marrow, liver and renal function.
  Exclusion Criteria:
  1. received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrollment);
  2. trastuzumab based adjuvant/neoadjuvant therapy;
  3. treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);
  4. patients with heart failure, coronary artery disease or myocardial infarction within the previous 6 months.
  5. trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Parathyroid Cancer Versus Atypical Parathyroid Neoplasm; Investigating Their Clinical Characteristics and Biological Behavior

Summary: Objectives:
  1. Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical neoplasms
  2. Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and have a different impact on the health of the patients

Detailed description: Data between the years of 1/1/2002 and 12/31/2013 will be analyzed. The medical records of all adult patients that had a parathyroidectomy for primary PHPT in MD Anderson Cancer Center will be screened in order to identify patients that had a histopathological diagnosis of parathyroid carcinoma or atypical parathyroid neoplasm.

Eligibility: Inclusion Criteria:
  -  All patients from MDACC diagnosed with PHPT that have a histopathological diagnosis of PTH carcinoma or atypical parathyroid neoplasm between the years 1/1/2002 and 12/31/2013
  Exclusion Criteria:
  -  Pediatric patients
  -  Cases with incomplete records
  -  Patients where the follow-up will be less than six months

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

Summary: A national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in women and men with HR+, HER2-negative advanced or metastatic breast cancer.


Eligibility: Inclusion Criteria:
  -  Patient is an adult, ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines
  -  Patients with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
  -  Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment.
  -  Patient must have either:
  1. Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).
  2. Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease
  3. Non-measurable disease
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  Exclusion Criteria
  -  Patient who received any CDK4/6 inhibitor or any mTOR inhibitor.
  -  Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole
  -  Patients with current inflammatory breast cancer.
  -  Patient has received > 1 chemotherapy for the treatment of advanced/metastatic breast cancer
  -  Patient has received > 2 endocrine therapies for the treatment of advanced/metastatic breast cancer
  -  Patient has central nervous system (CNS) involvement. If patient is fulfilling the following 3 criteria she/he is eligible for the trial.
  1. completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of study and
  2. CNS tumor is clinically stable at the time of screening and
  3. Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases
  -  Patient has active cardiac disease or a history of cardiac dysfunction

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer

Summary: This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (Pilot) II. To determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (Phase II)
  SECONDARY OBJECTIVES:
  I. Percent adherence to exercise at 1 year as measured by the International Physical Activity Questionnaire and exercise logs.
  II. Subjective arm health at 1 year as measured by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4).
  III. Arm lymphedema at 1 year as measured by arm circumference. IV. Arm range of motion at 1 year as measured by goniometry. V. Quality of life at 1 year as measured by FACT-B+4. VI. Percent increase in arm strength as measured by one repetition maximum at 1 year.
  VII. Change in weight and body mass index (BMI) 1 year after completion of radiation.
  OUTLINE: Patients are randomized to 1 of 2 arms.
  ARM I: Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
  ARM II: Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
  After completion of study, patients are followed up at 1 and 6 months, and 1 year.

Eligibility: Inclusion Criteria:
  -  Stage II-III breast cancer
  -  Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection
  -  Prior chemotherapy in the neoadjuvant or adjuvant setting
  -  Radiation plan consisting of regional nodal radiation
  -  Must be suitable for an exercise program
  Exclusion Criteria:
  -  Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician
  -  Physical handicap that would prevent participation in program
  -  Patients with metastatic breast cancer

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

Summary: [Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
  [Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy


Eligibility: [Inclusion Criteria]
  -  Provision of informed consent prior to any study specific procedures
  -  Men and women aged at least 18 years
  -  Small cell lung cancer harboring RICTOR amplification
  -  Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
  -  Minimum life expectancy of 12 weeks
  -  Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
  -  At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
  -  No history of non-autologous bone marrow transplant.
  Exclusion Criteria:
  -  Participation in another clinical study with an investigational product during the last 21 days.
  -  Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
  -  Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
  -  Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
  -  Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
  -  Any haemopoietic growth factors within 14 days prior to receiving study treatment.
  -  Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
  -  Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.

Relevance to patient case: not relevant