araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Assessment of Candidate Protein Expression in Breast Cancer Specimens

Summary: RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
  PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.

Detailed description: OBJECTIVES:
  -  To determine if candidate genes display differential expression between normal and cancer breast tissues.
  OUTLINE: Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of breast cancer
  -  Tissue samples available
  -  Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories:
  -  Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative
  -  ER-positive/PR-positive/ HER2-positive by FISH
  -  ER-negative/PR-negative/HER2-positive
  -  ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers)
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer

Summary: This is a research study in 2 parts assessing the following parameters of the combination of the study drug called bosutinib, and a drug called capecitabine: the safety, how well the subject's body handles the study drug, and preliminary anti-tumor activity as treatment for different types of cancers in part 1, and breast cancer only in part 2.
  In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels of each drug in order to determine the highest tolerated dose of the combination study treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest tolerated dose to see how well the study treatment works to treat breast cancer. In addition, genetic research testing (research analyses involving genes and gene products) will be performed on biological samples from subjects.

Detailed description: The study was prematurely discontinued following Part 1 evaluation, when the sponsor concluded that further translational biomarker analyses were needed to better define the breast tumor biomarkers that predict sensitivity to Src family kinase inhibitors. Thus the Sponsor made a determination to stop the study after Part 1 as communicated to investigators on 02Dec2010 . No subjects were enrolled into Part 2 of this study. The study was not terminated due to safety reasons.

Eligibility: Inclusion Criteria:
  Part 1:
  -  Ages eligible for study: 18 years or older.
  -  Male and female.
  -  Confirmed pathologic diagnosis of advanced breast cancer or pancreatic cancer or colorectal cancer or cholangiocarcinoma or glioblastoma not curable with available therapies, for whom bosutinib plus capecitabine is a reasonable treatment option.
  Part 2:
  -  Ages eligible for study: 18 years or older.
  -  Female.
  -  Confirmed pathologic diagnosis of locally advanced or metastatic breast cancer, or loco-regional recurrent breast cancer that is not amenable to curative treatment with surgery or radiotherapy.
  -  Documented ER+ and/or PgR+/erbB2- or ER-/PgR-/erbB2- tumor based upon recently analyzed biopsy.
  Exclusion Criteria:
  Part 1:
  -  Prior bosutinib, or any other prior Src inhibitor.
  -  Prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease is allowed unless patient stopped therapy for toxicity.
  Part 2:
  -  Prior bosutinib, or any other prior Src inhibitor prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease.
  -  Prior chemotherapy with capecitabine or 5-FU for adjuvant chemotherapy within the past 12 months.
  -  erbB2+ breast cancer.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy

Summary: We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. The results will be compared to a control group of normal healthy women. We will try to determine if MRI can be used to predict tumor response and cognitive changes related to the chemotherapy.

Detailed description: In this work we will utilize conventional magnetic resonance imaging as well as a set of advanced magnetic resonance imaging tools to investigate changes in tumor physiology and the human brain resulting from anthracycline-based systemic chemotherapy. We will recruit up to 15 subjects diagnosed with breast cancer and preparing for an anthracycline-based systemic chemotherapy regimen. Each subject will undergo the set of MR imaging tools before therapy, after one therapy session, after four therapy sessions, and at the conclusion of therapy. Conventional MRI methods will be used to quantify tumor-response to chemotherapy for each subject. A control group of up to 15 normal subjects will also be recruited and will undergo MR brain imaging twice with a gap of 6 months between scans. All subjects will also undergo a battery of neuropsychological tests at each imaging session. The results of the neuropsychological tests will be used to quantify cognitive changes for each subject. A final analysis will determine if the advanced MR modalities can be used to predict the response of tumors or human cognition to chemotherapy.

Eligibility: Inclusion Criteria:
  -  Diagnosed with Adenocarcinoma(ER+ve, PR+ve)
  -  Prescribed, but not yet begun, anthracycline based systemic chemotherapy
  -  Not prescribed Avastin
  -  Able to read and write in English
  -  Have signed informed consent
  Exclusion Criteria:
  -  Diagnosed psychiatric disorder
  -  Conditions that would preclude MRI (Pacemaker, metal objects in body, claustrophobia, pregnancy, etc.)
  -  Serious, unstable medical or mental illness
  -  Medical contraindication to any study procedure
  -  Current alcohol or other substance use disorder (excluding nicotine)
  -  Have not read and signed informed consent, or do not understand its contents

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Breast Cancer With Over-expression of erbB2-BRAINSTORM

Summary: This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.


Eligibility: Inclusion Criteria:
  1. Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
  2. Brain metastasis diagnosis made between January 2006 - December 2008.
  Exclusion Criteria:
  1. Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
  2. Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Brain Metastasis in Breast Cancer Patients

Summary: The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.

Detailed description: A retrospective cohort study will be conducted in the Henry Ford Health System (HFHS). Using medical record review, we will identify all women diagnosed with advanced stage (stage III and IV) breast cancer between January 1, 1995- December 31, 2007. For each case included in the study, we will obtain data on demographics, tumor information, treatment related medical encounters and procedures, and occurrence and timing of brain and/or other distant metastases. The main outcome for this study is the development of distant metastases. Each patient in the cohort will be classified as to the occurrence and date of distant metastases. Metastases will be classified as Brain, Distant lymph node, Lung/pleural effusion, Liver, Bone, Other visceral, Other non-visceral.
  Other secondary outcomes to be explored include:
  -  Survival after advanced breast cancer—time in months from the date of advanced stage breast cancer diagnosis until death or end of study period
  -  Time to brain metastases—time in month from the date of advanced stage breast cancer diagnosis until brain metastases diagnosis
  -  Survival after brain metastases—time in months from the date of diagnosis of brain metastases until death or end of study period

Eligibility: Inclusion Criteria:
  -  Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007;
  -  At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
  -  Age 30 years or older at diagnosis.
  Exclusion Criteria:
  -  Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
  -  Age less than 30 years or older at diagnosis.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: An Observational Study of the Mean Duration of Herceptin (Trastuzumab) Treatment in Patients With Early or Metastatic HER2-positive Breast Cancer (HERODOT)

Summary: This single arm observational study will assess the duration and safety of treatment with Herceptin (trastuzumab) in routine clinical practice in patients with early or metastatic HER2-positive breast cancer. Data will be collected from female patients treated with Herceptin according to the Summary of Product Characteristics and local protocols. Duration of observation for each patient is from therapy initiation until permanent discontinuation for any cause.


Eligibility: Inclusion Criteria:
  -  Female patients, >/= 18 years of age
  -  HER2-positive breast cancer
  -  Treated with Herceptin in accordance with Summary of Product Characteristics and local protocols
  -  Written informed consent to data collection
  Exclusion Criteria:
  -  Any contraindication to Herceptin
  -  Clinically relevant cardiovascular disorder or disease

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer

Summary: The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.


Eligibility: Inclusion Criteria:
  -  give voluntary signed informed consent
  -  have histologically documented prostate cancer
  -  have been on ADT treatment for 6 months prior to randomization or intermittent LHRHa for preceeding 12 months
  -  expected to continue LHRHa therapy uninterrupted for the next 12 months
  -  have total testosterone levels less than 50 ng/dL
  -  Have BMD of lumbar spine or femoral neck at or below the BMD thresholds
  -  have a Zubrod performance status <or equal to 1
  -  subject weight <300 lbs(<136 kg)
  -  agree to complete a daily diary of medication intake
  -  agree not to take excluded medications throughout the trial
  -  agree to use an effective method of contraception
  -  have adequate bone marrow, liver and renal functions
  Exclusion Criteria:
  -  Currently or previously exposed
  -  within the past 5 years to intravenous bisphosphonates, strontium ranelate or Denosumab
  -  for more than 3 years to oral bisphosphonates
  -  within the last 45 days to PTH or PTH derivative, anabolic steroids or testosterone, SERMs, calcitonin, calcitriol or oral gluccorticoids
  -  have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic or lumbar spine
  -  have <8 evaluable vertebrae
  -  have a BMD T score <-4 at the lumbar spine or total hip or femoral neck
  -  have any history of other carcinomas within the last 5 years
  -  Serum PSA > 5ng/mL at baseline under ADT
  -  have Paget's disease, Cushing's disease, chronic hepatitis or cirrhosis or rheumatoid arthritis
  -  have active uncontrolled systemic viral, bacterial or fungal infections
  -  have a clinically significant concurrent illness or psychological, familial, sociological, geograhical or other condition that would not permit adequate follow-up and compliance
  -  received treatment with other investigational agents within 30 days
  -  taking finasteride, dutasteride, danazol or testosterone like substances
  -  taking herbal medicines or dietary supplements
  -  have a history of thromboembolic disease including DVT or pulmonary embolus
  -  have a QTcF of > or equal to 450 msec or congenital or acquired QTc prolongation
  -  have HIV
  -  calcicum urolithiasis prohibiting the use of vitamin D

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Breast Cancer Registry - National University Health System, Singapore

Summary: The Breast Cancer Registry aims to collect clinical data of all breast cancer patients diagnosed and/or treated in the National University Hospital, with the goal of understanding risk factors, presenting symptoms, diagnosis, treatment, and outcome data of breast cancer in Singapore. This information will contribute to improving management of breast cancer patients.


Eligibility: Inclusion Criteria:
  - All breast cancer patients who were diagnosed or managed in NUH.
  Exclusion Criteria:
  - Non breast cancer patients.

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib

Summary: The purpose of this study is to understand how information of 3 specific biomarkers can provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.


Eligibility: Inclusion Criteria:
  1. HER2-positive (defined as either (a) IHC3+ or (b) FISH+ in local lab) recurrent / metastatic breast cancer patients who have received treatment with lapatinib-based regimen. These are either new, current or completed cases from any of the following settings:
  -  treated according to physician's clinical judgement in routine practice; or
  -  treated in clinical trials with known allocation to lapatinib-based regimen; or
  -  treated via lapatinib expanded access or named patient programs. These regimens should contain lapatinib as the only anti-HER2 agent.
  2. Exposed to < 2 lines of trastuzumab-based regimen in the metastatic setting prior to start of lapatinib-based regimen. These regimens should contain trastuzumab as the only anti-HER2 agent.
  3. Patients with an historical tumor biopsy specimen available from their primary breast cancer diagnosis. If this is not available, then at least a specimen should be available anytime during the period before the patient started on any anti-HER2 therapy.
  4. Willing to give written informed consent to release the tumor biopsy specimen with corresponding clinical data. If consent could be waived according to institutional practice (eg. patient already deceased, or patient previously provided blanket consent for institution to utilize tissue/data for research purpose), this is accepted with appropriate supporting documentation.
  Exclusion Criteria:
  1. Patients who have been exposed to other experimental anti-HER2 therapy eg. pertuzumab, trastuzumab-DM, neratinib, ertumaxomab, AV-412, BIBW2992, CUDC-101, anti-HER2 vaccines.
  2. Other primary lesions that are not of breast origin.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Positron Emission Tomography/Computed Tomography Scanning Before Surgery in Patients With Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Esophageal Cancer, or Head and Neck Cancer

Summary: RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease.
  PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.

Detailed description: OBJECTIVES:
  -  To determine the ability of preoperative fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning in assessing tumor angiogenesis in patients with potentially operable non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
  -  To determine the ability of preoperative fludeoxyglucose F 18 PET/CT scanning in assessing prognosis by means of measuring angiogenesis in these patients.
  OUTLINE: All patients undergo fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning for staging, tumor perfusion measurement/angiogenesis, and glucose metabolism. If staging confirms operable disease, then the patient proceeds to surgery as planned. Resected tumor tissue samples are examined for tumor angiogenesis in the various cancer types.
  Some patients undergo a half-dose of rubidium Rb-82 or 18F-fluoromisonidazole or [18F]-ML-10 PET scan or fluorescence angiography. Patients with colorectal cancer undergo a CT scan for perfusion of the tumor after the staging PET/CT. Patients with breast cancer undergo infrared thermometry as well as a MRI scan for staging and to predict angiogenesis.
  After completion of study therapy, patients are followed up at 1 month and then every 6 months for 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer
  -  Potentially operable disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Not specified
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer

Summary: The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.
  At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).


Eligibility: Inclusion Criteria:
  -  Female Patients with the diagnosis of Stage 0, I, II and III breast cancer diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady Memorial Hospital
  -  Age: no limit
  Exclusion Criteria:
  -  Stage IV breast cancers

Relevance to patient case: not relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Role of Early Versus Late Switch to Lapatinib-Capecitabine

Summary: The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).

Detailed description: All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting can participate in this observational study, for a period of 12 months of observation since the start of the lapatinib-capecitabine treatment.

Eligibility: -  Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice);
  -  Older than 18 years old;
  -  Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer;
  -  Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment;
  -  Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, in the community setting;
  -  Signed consent to participate and release information for this study.

Relevance to patient case: definitely relevant