araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

Summary: The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor

Detailed description: The purpose of the phase I dose escalation part of this study is to estimate the MTD(s) and/or identify the RP2D of the combination treatment of ribociclib+ everolimus + exemestane when dosed continuously in adult men and postmenopausal women with HR+ HER2-negative advanced breast cancer resistant to the non-steroidal aromatase inhibitors, fulvestrant or tamoxifen.
  The purpose of the phase II portion of this trial will be to evaluate the anti-tumor activity of exemestane, everolimus and ribociclib triplet following progression on a CDK 4/6 inhibitor. This part of the study will be conducted using a Simon's optimal two-stage design.

Eligibility: Inclusion Criteria:
  -  Adult men and women
  -  Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer
  -  Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.
  -  ECOG Performance Status 0 - 1
  -  Disease refractory to either, AI, tamoxifen or fulvestrant
  -  Previously treated on any CDK 4/6 inhibitor.
  -  Patient has adequate bone marrow and organ function.
  Exclusion Criteria:
  -  Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
  -  Patient has received more than one line of chemotherapy for advanced disease.
  -  Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
  -  Progressed on more than one CDK 4/6 inhibitor
  -  Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.
  -  Clinically significant, uncontrolled heart disease and/or recent cardiac events.

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

Summary: The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

Detailed description: The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .

Eligibility: Inclusion Criteria:
  -  Male and female patients between the ages of 18 and 89 years of age.
  -  Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
  -  Ability of participant to understand and the willingness to sign a written informed consent document.
  -  Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.
  Exclusion Criteria:
  -  Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
  -  Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
  -  Patients meeting the above enrollment criteria who have had CancerNext performed previously.

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Rural Interventions for Screening Effectiveness

Summary: This randomized clinical trial studies how well a tailored interactive digital versatile disc (DVD) with or without patient navigation works in improving screening rates in rural women for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and patient navigation may help rural women to learn more about cancer screening and to better understand the results.

Detailed description: PRIMARY OBJECTIVES:
  I. Compare the effectiveness of a tailored and interactive DVD (TIDVD) versus (vs.) TIDVD + telephone-based patient navigation (PN) intervention (TIDVD + PN) vs. usual care (UC), to increase guideline-based cancer screening rates at 12 months post randomization for breast cancer (BC), cervical cancer (CC), and colorectal cancer (CRC) among 1058 women age 50 to 74 living in rural northwest Ohio and northeast Indiana.
  II. Compare the cost effectiveness of the TIDVD and the TIDVD + PN intervention vs. UC, for adherence to each screening outcome or combination of screening tests.
  OUTLINE: Patients are randomized to 1 of 3 arms.
  ARM I: Patients watch a tailored interactive DVD program and answer questions posed by the DVD program.
  ARM II: Patients engage in TIDVD and PN.
  ARM III: Patients receive brochures that explain and provide encouragement for cancer screening.
  After completion of the study, patients are followed up at 2 and 12 months.

Eligibility: Inclusion Criteria:
  -  Be non-adherent to one or more recommended screenings for BC, CC, or CRC by Medical Record Review (MRR)
  -  Reside in one of 32 rural counties in Indiana (IN) or Ohio (OH)
  -  Provide informed consent
  -  Able to speak/read English
  -  Have access to a DVD player or computer that can play DVDs
  Exclusion Criteria:
  -  Have a personal or family history of any hereditary/genetic cancer syndrome such as BRCA1 and BRCA2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis
  -  Have a personal history of inflammatory bowel disease (Crohn's disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancer
  -  Have a first degree relative with a history of breast or colorectal cancer
  -  Plan to move outside of the country within the next year
  -  Reside in a nursing home or other institution
  -  Are pregnant or intend to become pregnant during the study period

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Brazilian Randomized Study - Impact of MRI for Breast Cancer

Summary: The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I, II and III candidates for conservative surgery will be randomly randomized to do MRI or not according mammary density.

Detailed description: The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer.An accurate assessment of the tumor is essential to select the best therapeutic strategy in the treatment of breast cancer.Currently, mammography, ultrasound and clinical examination are the standard techniques to assess the extent and location of the tumor.However, these imaging methods fail to assess the real size in approximately one third of patients eligible to conservative treatment.MRI has high sensitivity (95-100%) in the detection of invasive cancers as well as being able to detect hidden tumors, multifocality, multicentricity and cancer in the contralateral breast more often and greater accuracy than mammography or ultrasound.

Eligibility: Inclusion Criteria:
  -  Female,
  -  Over 18 years with breast cancer
  -  Clinical stages I, II and III candidates for conservative surgery
  Exclusion Criteria:
  -  Contra-indication for breast MRI (ex. Metal implant)
  -  Claustrophobia
  -  Impossibility to stay in the prone position for more than an hour
  -  History of allergic reaction to the paramagnetic contrast
  -  History of chronic kidney disease on dialysis
  -  Personal history of breast cancer treated surgically in the last 12 months.
  -  Pregnancy or breastfeeding past 6 months

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas

Summary: CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists.


Eligibility: Inclusion Criteria:
  1. Males and females ≥ 18 years of age;
  2. Life expectancy of at least 3 months;
  3. ECOG PS ≤ 1;
  4. Acceptable bone marrow and organ function at screening;
  5. Ability to swallow and retain oral medications;
  6. Negative serum pregnancy test in women of childbearing potential;
  7. Measurable disease;
  8. Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy, when applicable, does not exist or is no longer effective.
  Exclusion Criteria:
  1. Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
  2. Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
  3. Radiotherapy within the last 21 days;
  4. Primary brain tumors or CNS metastases;
  5. Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
  6. Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
  7. Active infection requiring systemic therapy;
  8. Receipt of vaccines against infectious diseases within 28 days;
  9. HIV positive or an AIDS-related illness;
  10. Active/chronic HBV or HCV infection;
  11. Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
  12. Cardiac dysrhythmias;
  13. Gastrointestinal disease that interferes with receipt of oral drugs;
  14. Concomitant malignancy;
  15. Pregnant or lactating female;

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older

Summary: The purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.

Detailed description: The investigators aim to use this information to further refine and evaluate a decision aid to help newly-diagnosed women aged 70 and older with breast cancer understand the risks and benefits of different types of breast cancer treatment. The Decision Aid (DA) was created for women 70 years or older diagnosed with ER+, HER2-, clinically LN-, 3cm or less breast cancers deciding on breast cancer treatment. The DA was designed considering the health literary, cognitive abilities, treatment outcomes, and competing health issues of older women.
  Phase I :
  - The investigators will obtain and incorporate additional feedback on the DA from women 70 years or older who were diagnosed with breast cancer > 6 months ago, their family members, and clinicians, so that the DA can be refined and evaluated by women who were recently treated for breast cancer but not newly diagnosed with breast cancer.
  Phase II
  - The investigators plan to test the efficacy of the revised DA in a randomized control trial (RCT) of 230 diverse women 70 years or older newly diagnosed with ER+, LN-, HER2-, 3 cm or less breast cancer.

Eligibility: Inclusion Criteria:
  -  Phase I
  -  Patient age ≥ 70 yrs
  -  Female patient diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer >6 months ago but <2 years ago
  -  Caregiver age >21 years
  -  English speaking
  -  Phase II
  -  Female patient age ≥ 70 yrs newly diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer
  -  Women newly diagnosed with breast cancer on the day of surgical consult
  Exclusion Criteria:
  -  Phase I
  -  Patient Age < 70 years
  -  Women diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor
  -  Signs of Dementia
  -  Score >10 on the Orientation-Memory-Concentration (OMC) test
  -  Non-English Speaking;
  -  Caregiver age < 21 years
  -  Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded.
  -  Phase II
  -  Women with a history of breast cancer (invasive and non-invasive)
  -  Diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor
  -  Signs of Dementia
  -  Score >10 on the OMC test (indicative of dementia).
  -  Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded.

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Family Lifestyle Actions and Risk Education Study

Summary: The overall purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a family-focused behavioral intervention ("FLARE", which stands for Family Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive behaviors among children at elevated risk for the disease.


Eligibility: Inclusion Criteria:
  Children
  -  Are 8-17 years old AND
  -  Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma AND/OR
  -  Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing
  Adults
  -  Are at least 18 years old AND
  -  Are the primary caregiver for the child participating in the study (defined as the individual who is responsible for daily implementation of health-related tasks for the child) AND
  -  Have at least one child under age 18 who is living in the same household AND
  -  Have a personal history of melanoma and/or family history of melanoma) AND/OR
  -  Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing
  Exclusion Criteria:
  -  Individuals who do not speak, read/write English will be excluded because FLARE involves regular interaction between study staff and research participants in English and completion of study questionnaires and interviews in English

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Genotyping 2 SNPs in Chinese Breast Cancers

Summary: The purpose of this study is to determine the frequency of two Single Nucleotide Polymorphisms (SNPs) by sanger-sequencing in Breast Cancers and healthy controls .

Detailed description: Since the 1990s breast cancers incidence of china has increased more than twice as fast as global rates. Chinese patients are responsible for 12.2% of all newly diagnosed breast cancers and 9.6% of all deaths to world breast cancers. Breast cancer is now the second frequently diagnosed cancer and is the leading cause of cancer-related death in Chinese women.
  Two of the most prevalent breast cancer susceptibility genes are BRCA1and BRCA2. However，because of population based Genetic heterogeneity, the frequency of BRCA1/BRCA2 mutation is not as high in Caucasian population as in China. Anyway, the mean age at diagnosis of breast cancer in China is almost 10 years younger and more cases are diagnosed before 40 than those in Caucasians. Therefore, it is believed that there are certain specific susceptibility loci in Chinese breast cancers.
  In preliminary experiments, investigators found two germline mutations may associate with Chinese breast cancers.
  The purpose of the study is to determine the frequency of two germline mutations by sanger-sequencing in a larger sample of Chinese breast cancers

Eligibility: Inclusion Criteria:
  -  Woman aged superior to 18 years old Inform consent signed Woman without breast cancer and family history of cancer
  Exclusion Criteria:
  -  No inform consent signed Patient under guardianship, curatorship Psychosocial disorder

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer

Summary: To test the feasibility of supportive-expressive group intervention (SEGT) for women with primary breast cancer and to provide a preliminary test of its efficacy.

Detailed description: This study aims to compare the efficacy of a 16-sessions group intervention (Supportive-Expressive group therapy) versus control group (no intervention) in women with primary breast cancer.
  This study tries to evaluate the efficacy of SEGT on breast cancer patients' emotion regulation, social support, caregiving, and marital satisfaction, and its improvement on breast cancer patients' life quality. This study also intents to explore the moderating role of attachment on these associations.

Eligibility: Inclusion Criteria:
  -  diagnosis of primary breast cancer
  Exclusion Criteria:
  -  attendance at a cancer support group or individual psychotherapy
  -  diagnosis of recurrent breast cancer
  -  severe psychiatric disorder
  -  history of drug or alcohol abuse

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Neoadjuvant Carboplatin in Triple Negative Breast Cancer

Summary: Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.


Eligibility: Inclusion Criteria:
  -  Triple Negative Breast Cancer;
  -  Stage II or III;
  -  Performance Status ECOG <2 or Karnofsky >50%;
  -  Hematologic (minimal values):
  Absolute neutrophil count > 1,500/mm3 Hemoglobin > 10.0 g/dl Platelet count > 100,000/mm3
  Exclusion Criteria:
  -  Stage I or IV;
  -  other malignancies.

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

Summary: This study will allow for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.

Detailed description: This protocol is a sub-protocol of an interventional study. Because the main study is interventional, this study was approved by FDA as an interventional study. It cannot stand alone without the parent study. The sites will receive diagnostic information for all patients that come on study.

Eligibility: Inclusion Criteria:
  -  Written informed consent must be obtained prior to any baseline/screening procedures.
  -  Patients eligible for this companion sample collection protocol sample collection protocol must meet all inclusion in CLEE011A2404.
  Exclusion Criteria:
  -  Patients eligible for this companion sample collection protocol must not meet any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
  -  Patients without either fresh or archival tumor tissue accessible.

Relevance to patient case: definitely relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Smart Phone Application in Increasing Physical Activity in Breast Cancer Survivors

Summary: This pilot clinical trial studies how well a smart phone application works in increasing physical activity in breast cancer survivors. A smart phone application that increases physical activity may help reduce the likelihood of cancer coming back in breast cancer survivors.

Detailed description: PRIMARY OBJECTIVES:
  I. To conduct a pilot study to inform the design of a mobile health application for smartphone that is targeted to increase physical activity and reduce risks associated with breast cancer.

Eligibility: Inclusion Criteria:
  -  A participant is only able to participate in one phase, not both phases, of the research study
  -  Must have completed breast cancer treatment
  -  Those on adjuvant hormonal therapy are allowed to participate in the research study (either phase)
  Exclusion Criteria:
  -  Those who currently meet the Centers for Disease Control and Prevention (CDC)'s physical activity guidelines
  -  Those who do not currently use a smartphone (of any kind)
  -  Those who do not read and speak English

Relevance to patient case: not relevant