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

Clinical trial: Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

Summary: This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum
  -  Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast
  -  Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma.
  -  Performance status of no more than 2.
  Exclusion Criteria:
  -  Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
  -  Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .

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

Clinical trial: Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

Summary: The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer


Eligibility: Inclusion Criteria:
  -  Inoperable estrogen receptor positive and HER2 negative breast cancer.
  -  Postmenopausal status.
  -  Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.
  -  Acceptable bone marrow, liver and kidney function.
  Exclusion Criteria:
  -  Prior or concomitant treatment for advanced breast cancer.
  -  Other major cancer in the past 3 years.
  -  Important cardiovascular events in the past 6 months.

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

Clinical trial: Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies

Summary: The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

Detailed description: To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed breast cancer prior to receiving breast cancer therapy.
  -  Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.
  Exclusion Criteria:
  -  Poorly controlled diabetes.
  -  Contralateral mastectomy prior to neoadjuvant chemotherapy.
  -  Not a surgical candidate.
  -  No previous axillary lymph node dissection.

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

Clinical trial: Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography

Summary: The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.


Eligibility: Inclusion Criteria:
  -  Females 30 years of age or older.
  -  Dense Breasts.
  -  Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
  -  Suspicious or palpable mass and scheduled for biopsy.
  Exclusion Criteria:
  -  Pregnant or lactating women.
  -  Prior personal history of breast cancer.
  -  Prior breast augmentation with implants or silicon injection. male patients.
  -  No two view mammogram as part of breast imaging evaluation.
  -  Breast density of almost entirely fatty/scattered fibroglandular densities.

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

Clinical trial: An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)

Summary: This is a multicenter, prospective observational cohort study (OCS) designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:
  -  Patients with human epidermal growth factor receptor 2-negative (HER2-negative) disease receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825 patients)
  -  Patients with hormone receptor-positive (HR-positive) disease receiving their first hormonal therapy for advanced disease (approximately 425 patients)
  Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be enrolled. Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010.


Eligibility: Inclusion Criteria:
  -  Signed Informed Consent Form
  -  Locally recurrent or metastatic breast cancer
  -  Receipt of first systemic cytotoxic chemotherapy and/or targeted therapy among those with HER2-negative disease or first hormone therapy among those with HR-positive disease for the treatment of locally recurrent or metastatic disease, within 8 weeks prior to enrollment
  Exclusion Criteria
  -  Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment
  -  Any prior chemotherapy started more than 8 weeks prior to enrollment for the treatment of locally recurrent or for metastatic breast cancer
  -  Concurrent participation only in a blinded clinical trial

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

Clinical trial: SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)

Summary: To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.


Eligibility: Inclusion Criteria:
  -  Age >=18 years, either sex, any race.
  -  Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease.
  -  BREAST CANCER:
  -  participant must have previously received both a taxane and an anthracycline (unless anthracycline therapy is contraindicated) in the adjuvant and/or metastatic setting,
  -  participant with HER2-positive disease must have progressed after trastuzumab and concomitant or subsequent lapatinib,
  -  participant must have received at least one, but no more than two prior regimens for recurrent or metastatic disease (endocrine and biologic therapies do not count as chemotherapeutic regimens).
  -  NSCLC: at least one, but no more than two prior chemotherapeutic regimens for advanced disease.
  -  Measurable disease by the RECIST.
  -  Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
  -  Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
  -  Ability to swallow tablets.
  Exclusion Criteria:
  -  Known brain metastases. For NSCLC only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization.
  -  History of previous radiation therapy to >25% of total bone marrow.
  -  Known HIV infection.
  -  Known active hepatitis B or hepatitis C.
  -  Previous treatment with SCH 727965 or other cyclin-dependent-kinase inhibitors.
  -  BREAST CANCER:
  -  known dihydropyrimidine dehydrogenase deficiency,
  -  previous treatment with capecitabine.
  -  NSCLC: previous treatment with erlotinib.

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

Clinical trial: A Phase I/II Clinical Trial of Vidaza With Abraxane in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer

Summary: The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Detailed description: The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.

Eligibility: Inclusion Criteria:
  1. For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.
  2. For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
  3. Her-2/neu negative (Phase II)
  4. Negative pregnancy test for female subjects
  5. Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.
  6. Male or female for phase I and female for phase II, >19 years of age and any race.
  Exclusion Criteria:
  1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
  2. Known brain metastases
  3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
  4. Active infection requiring antibiotic therapy
  5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
  6. Grade 2 or greater motor or sensory neuropathy
  7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
  8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
  9. Known or suspected hypersensitivity to azacitidine or mannitol
  10. Pregnant or breast feeding
  11. Patients with advanced malignant hepatic tumors
  12. Malignancy other than breast carcinoma (phase II)
  13. Known HIV infection or chronic hepatitis B or C

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

Clinical trial: Use of Molecular Breast Imaging (MBI) to Detect Additional Disease in Women With Breast Cancer Who Are About to go to Surgery

Summary: Conventional mammography is not a reliable method for determining the extent of disease in women with breast cancer. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that allows the breast to be imaged in a manner similar to mammography, but without the pain of compression. Initial results with this method have shown it is very good at detecting small breast cancers (~1/4 inch).
  The purpose of this study is to see if MBI is a better method than mammography in determining how much cancer is present before a woman goes to surgery.
  The study will comprise 120 women with breast cancer who are going to surgery. The investigators hope that this study will demonstrate that MBI will be more accurate in determining how much cancer is present.

Detailed description: The sensitivity of conventional mammography for evaluation of extent of disease, detection of multifocal breast cancers and contralateral breast cancers is poor. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that permits the breast to be imaged in a manner similar to mammography, utilizing a Cadmium-Zinc-Telluride (CZT) gamma camera. We have developed the first dual-head MBI system in the world and preliminary results from this system indicate a high sensitivity (~90%) for the detection of breast cancers < 10mm.
  The AIM of this study is to determine the sensitivity of MBI relative to mammography in the preoperative evaluation of the extent of disease in the ipsilateral and contralateral breasts in women with biopsy-proven breast cancer. We will test the HYPOTHESIS that MBI is more sensitive than mammography for preoperative evaluation and surgical planning.
  The study will comprise 120 women with biopsy-proven breast cancer prior to surgery. All patients will have a diagnostic mammogram and an MBI study prior to operation. At the time of operation the pathologic findings will be correlated with both the mammogram and the MBI results.
  This study will demonstrate the use of MBI in three aspects of breast cancer diagnosis: 1) detection of multifocal / multicentric disease elsewhere in the ipsilateral breast, 2) detection of contralateral breast cancer, and 3) correlation of index tumor size on MBI with pathologic size. These results may justify a role for MBI in the routine pre-operative evaluation of breast cancer patients.

Eligibility: Inclusion Criteria:
  -  Women with biopsy-proven breast cancer (invasive breast cancer or ductal carcinoma in situ)
  Exclusion Criteria:
  -  Unable to understand and sign the consent form
  -  Pregnant or lactating
  -  Physically unable to sit upright and still for 40 minutes
  -  Currently receiving neoadjuvant chemotherapy or hormonal therapy
  -  Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor
  -  Previous mastectomy
  -  Previous excisional biopsy of the index breast cancer

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

Clinical trial: Gene Therapy in Treating Women With Metastatic Breast Cancer

Summary: RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.
  PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.

Detailed description: OBJECTIVES:
  -  Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.
  -  Determine the tumor response in patients treated with this regimen.
  -  Determine the immune response in patients treated with this regimen.
  OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance.
  Blood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.
  After completion of study therapy, patients are followed periodically.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
  -  Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection
  -  Solitary or multiple tumors
  -  Measurable disease in ≥ 2 dimensions by physical examination or CT/MRI scan
  -  Malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination
  -  Malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination
  -  Malignant disease in other organs (in addition to skin or chest wall metastases) allowed
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Karnofsky performance status 70-100%
  -  Life expectancy ≥ 16 weeks
  -  Granulocyte count ≥ 1,500/mm^3
  -  Platelet count ≥ 100,000/mm^3
  -  Hemoglobin ≥ 9.0 mg/dL
  -  PT normal
  -  Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
  -  Serum total bilirubin ≤ 2.0 times upper limit of normal (ULN)
  -  Serum transaminases ≤ 2.5 times ULN
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Weight ≥ 30 kg (for patients treated with the highest dose level of study drug)
  -  No active infection or concurrent serious medical illness
  -  No HIV positivity
  -  No other malignancy within the past 5 years except for the following:
  -  Inactive nonmelanoma skin cancer
  -  In situ carcinoma of the cervix
  -  Grade 1 papillary bladder cancer
  PRIOR CONCURRENT THERAPY:
  -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  -  No anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment

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

Clinical trial: Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer

Summary: This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer.

Detailed description: Hereditary breast/ovarian cancer syndrome is associated with mutations in tumor suppressor BRCA1 and BRCA2 genes. Products of these genes play an important role in the repair of DNA double-strand breaks. Mutations in BRCA1 and BRCA2 genes could impair DNA repair. In resting or G1 cells, where the de novo synthesis of DNA precursors is absent, the salvage pathway is the sole provider of deoxyribonucleotides to be used in DNA repair. For this process a sufficient supply of deoxynucleotides and activity of Thymidine Kinase 1 are essential. TK1 is an important component of adaptive response of cells to DNA damage. Mutations in genes directly engaged in the DNA repair process could lead to the accumulation of DNA damage and in turn cause an adaptive cell reaction manifesting as permanently increased Thymidine Kinase 1 activity.
  A recently developed new high-sensitive assay DiviTum® allows to investigate the contribution of this enzyme to DNA repair processes and to make a comparison of Thymidine kinase 1 activity in women with normal and impared DNA repair system.

Eligibility: Inclusion Criteria:
  -  women from family with more than two breast cancer cases and one or more cases of ovarian cancer diagnosed at any age;
  -  women from family with more than three breast cancer cases diagnosed before the age 50;
  -  women from family withsister pair in which one of the following combinations was diagnosed before the age of 50: two breast cancers, two ovarian cancers, or a breast and ovarian cancer.
  Exclusion Criteria:•
  -  pregnant women;
  -  women with generalized CMV and HZV infections;
  -  women with severe B12 deficiency and megaloblastic anaemia;
  -  women with severe rheumatoid arthritis.

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

Clinical trial: A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer

Summary: This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is < 3 months, and the target sample size is <100 individuals.


Eligibility: Inclusion Criteria:
  -  female patients, >=18 years of age;
  -  invasive, and operable, breast cancer;
  -  ECOG Performance Status of 0 or 1.
  Exclusion Criteria:
  -  evidence of metastatic disease;
  -  inflammatory breast cancer;
  -  prior hormonal or systemic therapy for breast cancer;
  -  prior treatment with an agent targetting the IGF-1R pathway;
  -  patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.

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

Clinical trial: Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer

Summary: RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.
  PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.

Detailed description: OBJECTIVES:
  -  To develop new in vivo models of human breast cancer.
  -  To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.
  OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.
  Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of breast cancer
  -  Any stage of disease
  -  Primary or metastatic disease
  -  Human breast tumor tissues available after the diagnoses have been made
  -  Enrolled on the ongoing Breast Tissue Repository trial VU-VICC-BRE-03103
  -  Have consented to the use of their tissues for research purpose
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant