araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

Summary: The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.


Eligibility: Inclusion Criteria:
  -  Stable coronary artery disease for 3 months or more
  -  18 years of age or older with a history of migraine with or without aura
  -  Must use acceptable contraception throughout the study
  Exclusion Criteria:
  -  Pregnant, breast-feeding, or planning to become pregnant during this study
  -  50 years of age or older when migraines began
  -  Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  -  History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Self-Care for Lymphedema in Patients With Breast Cancer

Summary: RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan better at-home self-care treatment.
  PURPOSE: This research study is looking at self-care practices for lymphedema in patients with breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To systematically identify and describe the barriers to completing recommended at home self-care of lymphedema in patients with breast cancer.
  -  To identify patient recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others.
  -  To identify the current at home self-care practices of breast cancer survivors with treatment treated lymphedema.
  Secondary
  -  To examine the relationship between at home self-care activities and symptoms in breast cancer survivors with lymphedema.
  -  To examine the relationship between at home self-care activities and quality of life in breast cancer survivors with lymphedema.
  -  To identify patient-perceived benefits to at home self-care.
  OUTLINE: Patients complete questionnaires about their breast cancer diagnosis and treatment history, lymphedema history and problems, and years of education and income. Patients also complete surveys about home self-care practices for lymphedema and any benefits, burdens, or barriers of at home care.

Eligibility: DISEASE CHARACTERISTICS:
  -  History of breast cancer
  -  Lymphedema in one or both arms that occurred during or after breast cancer treatment
  -  Must have received prior lymphedema treatment by a healthcare professional
  -  Patients with self-reported arm swelling subsequent to breast cancer treatment that has not been treated by a healthcare professional are not eligible
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  English speaking
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

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: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer

Summary: The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.

Detailed description: In DBCG trial 89D we in more than 1,200 patients showed that substitution in CMF chemotherapy of methotrexate with epirubicin improves survival for patients with primary and operable breast cancer. In a retrospective evaluation we have also shown that approximately 20% of all patients in 89D have tumors with numerical changes of the TOP2A gene, and that only patients with abnormal TOP2A benefit from epirubicin. In the current trial the DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.

Eligibility: Trial Population:
  1. Younger than 35, but at least 18 years of age
  2. Hormone receptor-negative tumor (ER- and PgR-negative) and 35 to 75 years of age.
  3. Hormone receptor-positive tumor, 35 to 59 years of age and presenting at least one of the following characteristics: spread to lymph nodes, tumor > 2 cm, degree of malignancy II-III or HER2-positive.
  Inclusion Criteria:
  1. Signed informed consent
  2. Histologically confirmed invasive breast carcinoma which has been micro-radical removed by breast preserving surgery or mastectomy according to DBCG's guideline
  3. TOP2A normal tumor (score of 0.8 - 2.0)
  Exclusion Criteria:
  1. Pregnancy or breast-feeding
  2. Earlier medical cancer treatment, including docetaxel, epirubicin or cyclophosphamide.
  3. Distant metastases or bilateral breast cancer (excluded after checking by means of chest radiography, bilateral mammography and normal blood samples as a minimum).
  4. Other active, malign disease in the latest 5 years, except for adequately treated and cured carcinoma in situ cervices uteri or non-melanoma skin cancer.
  5. Comorbidity score > 3 (patients with a score of 1-2 start at dose level -1).
  6. Treatment with a non-approved product or test product in the latest 30 days.
  7. Known severe hypersensitivity to docetaxel, epirubicin or cyclophosphamide or auxiliary agents in these products.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer

Summary: This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population

Detailed description: Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. However, triple negative breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed metastatic breast adenocarcinoma
  -  No HER2 overexpression or gene amplification
  -  Absent or low ER or PR expression
  -  No previous therapy for metastatic breast cancer is allowed
  -  Age 18-75 years
  -  Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
  -  Performance status (WHO) 0-2
  -  Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
  -  adequate renal function (serum creatinine <1.5 times the upper normal limit)
  -  bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
  -  No radiation of measurable disease (except brain metastases)
  -  No progressive brain metastases according to clinical or radiological criteria
  -  No brain metastases without prior radiation therapy
  -  Written informed consent
  Exclusion Criteria:
  -  Active infection
  -  History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  -  History of stroke
  -  Anticoagulation therapy (except of low dose aspirin <325mg)
  -  Other invasive malignancy except nonmelanoma skin cancer
  -  Psychiatric illness or social situation that would preclude study compliance
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

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: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Summary: Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.
  Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.


Eligibility: Inclusion Criteria:
  -  Hystological diagnosis of breast cancer
  -  Availability of tumor tissue
  -  Availability to assess the response to Trastuzumab according to RECIST criteria
  -  Availability of clinical data
  Exclusion Criteria:
  -  Unavailability of tumor tissue
  -  Impossibility to assess the response to Trastuzumab according to RECIST criteria

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


Eligibility: Inclusion Criteria:
  -  Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
  -  Prior use of Herceptin (trastuzumab), and a taxane
  -  Adequate cardiac and renal function
  Exclusion Criteria:
  -  More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
  -  Bone as the only site of disease
  -  Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
  -  Significant gastrointestinal disorder with diarrhea as major symptom

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer

Summary: The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).


Eligibility: Inclusion Criteria:
  -  KPS performance status of >= 80% ("normal activity with effort")
  -  Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC")
  -  Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
  -  Measurable disease by RECIST Criteria
  Exclusion Criteria:
  -  Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors
  -  Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
  -  Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits
  -  Moderately severe dry eye
  -  Congestive heart failure, or a left ventricular ejection fraction
  -  Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
  -  Previous malignancies unless free of recurrence for at least 5 years

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer

Summary: The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue.

Detailed description: -  Participants will have a TOBI scan prior to starting their cancer treatment and again on day 8 after their first treatment. Participants will also be asked if they would volunteer to undergoing one or more additional TOBI scans on days 2-7 after they begin cancer treatment. These additional scans are optional. Participants will also have a scan on the first day of each treatment cycle.
  -  TOBI scans will be performed at the Gillette Center for Breast Cancer at the Massachusetts General Hospital.
  -  For the scan, each breast is placed between 2 plastic plates in order to spread the tissue apart, similar to the procedure for a mammogram. The TOBI scanner is attached to these plates. We will apply mild pressure to compress the breast and the breast will be scanned using light waves. Each scan will take about 3 minutes.

Eligibility: Inclusion Criteria:
  -  Adult female patients presenting to the MGH Cancer Center Gillette Center for breast cancer neoadjuvant therapy
  -  Subject who have had or will have a clinically indicated pre-treatment breast MRI
  Exclusion Criteria:
  -  Younger than 18 years of age
  -  Open wounds on breast
  -  Breast implants, because they may interfere with readings
  -  Subjects who will be receiving preoperative therapy for <28 days
  -  Breast surgery or biopsy < 10 days prior to optical imaging scan
  -  Medical or psychiatric or other medical condition that the principal investigator believes may result in inability to complete the study
  -  Bilateral breast cancers or a history of contralateral breast cancer

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)

Summary: A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.


Eligibility: Inclusion Criteria:
  -  Patient is 18 years of age or older
  -  Patient has had a history of migraine with or without aura
  -  Patient is able to complete study questionnaire(s) and paper diary
  Exclusion Criteria:
  -  Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study
  -  Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions
  -  Patient was older than 50 years of age at migraine onset
  -  History of gastric or small intestinal surgery or has a disease that causes malabsorption
  -  Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study
  -  Currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study
  -  Currently participating in a study with MK-0974 or MK-3207

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

Summary: This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.


Eligibility: Inclusion Criteria:
  -  Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
  -  Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
  -  Patient can distinguish between migraine and other types of headache
  -  Patient agrees to remain abstinent or use effective birth control during the study
  Exclusion Criteria:
  -  Patient is pregnant or breast-feeding
  -  Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
  -  Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
  -  Patient was > 50 years old at age of migraine onset
  -  Patient has history of heart disease
  -  Patient has uncontrolled hypertension
  -  Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
  -  Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
  -  Patient is taking more than one other migraine prophylactic medication
  -  Patient has repeatedly failed to respond to or tolerate rizatriptan

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Summary: The purpose of this study is to analyze gene expression signature and immunohistochemical markers associated with clinical and pathological response to neoadjuvant chemotherapy in locally advanced breast cancer.

Detailed description: Locally advanced breast cancer is a common condition in development countries. Neoadjuvant chemotherapy gives the opportunity to identify genetic signatures associated with objective clinical and pathological complete responses.
  Patients will receive doxorubicin/cyclophosphamide with paclitaxel. Tumor samples collected before and after chemotherapy will be analyzed.

Eligibility: Inclusion Criteria:
  -  Women with locally advanced women breast cancer
  -  Histology: ductal ou lobular invasive histology
  -  Agreement to take part in the study and signature of the informed consent
  -  Clinical condition to receive doxorubicin/cyclophosphamide and paclitaxel
  -  ECOG 0 or I
  Exclusion Criteria:
  -  Not clinical stage III
  -  Inflammatory breast cancer
  -  Previous treatment
  -  Previous diagnosis of cancer (except basal cell or squamous cell skin carcinoma and non-invasive cervical carcinoma)
  -  Pregnancy
  -  Absence of clinical condition to receive chemotherapy

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Level of HER2-neu Gene Amplification an Response to Trastuzumab

Summary: Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility: Inclusion Criteria:
  -  HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
  Exclusion Criteria:
  -  HER2-negative advanced breast cancer Pretreatment with trastuzumab

Relevance to patient case: not relevant