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

Clinical trial: Quality of Life in African-American or Caucasian Female Breast Cancer Survivors

Summary: RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors.
  PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors.

Detailed description: OBJECTIVES:
  -  Compare disease-specific, generic, and global quality of life measures in African-American survivors of breast cancer with Caucasian survivors of breast cancer.
  -  Compare these quality of life measures in African-American survivors of breast cancer with control group of African-American women with no history of breast cancer.
  OUTLINE: Patients and healthy participants complete a battery of quality of life (QOL) questionnaires over approximately 65 minutes by mail or over the phone, including the Sexual Function Index, Functional Assessment of Cancer Therapy - Fatigue, Concerns About Recurrence Scale, and other measures of symptoms/side effects (including sleep problems), the RAND Physical Functioning -10 Scale, Center for Epidemiologic Studies - Depression Scale, assessment of family function/social support, ENRICH Marital Satisfaction Scale, Reed Spiritual Perspective Scale, assessments of coping and body image, Post-Traumatic Growth Inventory, and the Index of Well-being. Demographic, disease, treatment, and comorbidity information, as well as menstrual and gynecological history, work status and insurance history, and a measure of health care provider communication is collected using questionnaires and medical chart review.
  PROJECTED ACCRUAL: A total of 195 patients and healthy participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  African-American or Caucasian breast cancer survivor
  -  Diagnosed with stage I-III breast cancer between the years of 1995-2003
  -  Receiving follow up care at the Indiana University Cancer Center (IUCC), the IUCC Northside Clinic, Spring Mill Clinic, or Wishard Memorial Hospital
  -  Healthy African-American
  -  Acquaintance of an African-American breast cancer survivor
  -  Not known to have breast cancer
  PATIENT CHARACTERISTICS:
  -  Female
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: A Study of ARRY-334543 in Patients With Advanced Cancer

Summary: This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543.
  This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).
  In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).


Eligibility: Key Inclusion Criteria (Part 2):
  -  Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor.
  -  Measurable disease (at least 1 target lesion) according to modified RECIST.
  -  Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy.
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  -  Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy.
  -  Additional criteria exist.
  Key Exclusion Criteria (Part 2):
  -  Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
  -  Use of an investigational medication or device within 30 days prior to first dose of study drug.
  -  Major surgery within 30 days prior to first dose of study drug.
  -  Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
  -  Pregnancy or lactation.
  -  Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for hepatitis B and/or hepatitis C.
  -  Additional criteria exist.

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

Clinical trial: EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Summary: This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies


Eligibility: Inclusion criteria:
  -  May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted.
  -  Prior treatment with hormonal therapy is allowed.
  -  Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting.
  -  Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.
  -  Must be >/= 18 years of age
  -  Life expectancy of > 8 weeks
  -  Must have recovered from side effects of previous treatment
  -  Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required
  -  Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed
  -  Able to swallow and retain oral medications
  -  Must have adequate hematologic, hepatic and renal function
  Exclusion criteria:
  -  Pregnant or lactating females
  -  Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis
  -  Concurrent disease or condition that would make the patient inappropriate for study participation
  -  Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment
  -  Uncontrolled infection
  -  Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient
  -  Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed
  -  History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients
  -  History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients
  -  Known DPD deficiency

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

Clinical trial: Isolation and Characterization of Mammary Stem Cells

Summary: Background:
  -  Cancer stem cells in breast cancer have been identified as a small population of tumor cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be necessary for cancer to develop.
  -  These cells can be identified by certain surface markers that overlap with markers associated with normal embryonic stem cells.
  Objective: To isolate tumor stem cells using the same methods generally used to isolate human embryonic stem cells.
  Eligibility:
  -  Tissue samples will be obtained from the human cooperative network.
  -  Samples will include normal tissues from individuals who have no opportunistic diseases and from individuals with cancer.
  Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.

Detailed description: Cancers are composed of heterogeneous populations of cells with varying degrees of proliferative capacity and ability to reconstitute tumors when transplanted into nude or SCID mice.
  Recently, cancer stem cells have been identified as a small population of tumor cells which possess the stem cell properties in that their self-renewal pathway is highly deregulated. This deregulation seems to be the prerequisite for the development of cancer.

Eligibility: -  INCLUSION CRITERIA:
  The tissue samples will come from the human cooperative network. They have their own set of criteria. We are requesting tissue samples from individuals that are normal as well as those who have cancer.
  EXCLUSION CRITERIA:
  The tissue samples will come from the human cooperative tissue network and we are asking for normal samples from individuals who don't have any opportunistic diseases.

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

Clinical trial: Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy

Summary: The purpose of this study is to see what kinds of breast tumors will respond to lapatinib. Lapatinib is an experimental medicine which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically-confirmed by either core or fine needle biopsy primary invasive carcinoma of the breast;
  -  AJCC T2-T3 disease (>2.0 cm without chest wall or skin invasion) by at least one imaging modality (either mammogram, ultrasound, or MRI) - entry criteria is based on radiologic staging and not final pathologic staging;
  -  ECOG performance status 0-1 (Karnofsky ≥ 70%
  -  Any lymph node status, hormone receptor status, and level of erbB2 expression
  -  No prior chemotherapy, hormonal therapy or radiation therapy to the affected breast for current or previous malignancy;
  -  Cardiac ejection fraction >50% or within the institutional range of normal;
  -  Patients must have normal organ and marrow function defined as: Leukocyte count >3000/uL; Absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets > 100,000/mm3, and hemoglobin ≥ 8 gm/dl; Serum creatinine ≤ 1.5 times ULN, or 24-hour creatinine clearance ≥ 75 cc/min; Serum bilirubin ≤ 1.5 times ULN; SGOT ≤ 2.5 times ULN; alkaline phosphatase ≤ 2.5 ULN times ULN.
  -  The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  -  Ability to understand and the willingness to sign written informed consent document.
  Exclusion Criteria:
  -  AJCC T1, T4, or stage 4 disease;
  -  Patients may not have undergone incisional or excisional biopsy of their tumor;
  -  Patients may not be receiving any other investigational agents;
  -  Absolute contraindication to MRI imaging (cardiac pacemaker or any non-removable metallic foreign object in the body);
  -  On chronic therapy with any known inducer or inhibitor of CYP3A4
  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  -  Pregnant or lactating women are excluded from this study because lapatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects.

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

Clinical trial: Genetic Counseling for Menopausal Therapy Decision-Making for Women at Increased Risk for Breast Cancer

Summary: The purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.

Detailed description: Women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy, alternative medications, or no treatment. This complex decision should be based on each woman’s risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. Current models in use for menopausal therapy counseling do not include pedigree analysis, personalized risk assessment or genetic testing in this process. The purpose of this multi-center study is to determine the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in a group of healthy women who had a first-degree relative with breast cancer. Intervention participants will be given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data.

Eligibility: Inclusion Criteria:
  -  at least one first degree relative with breast cancer
  -  age 40 or older
  Exclusion Criteria:
  -  currently taking a menopausal therapy
  -  previous cancer diagnosis (except basal cell carcinoma)
  -  previous diagnosis of atypical hyperplasia
  -  previous diagnosis of lobular carcinoma in situ (LCIS)
  -  known carrier of a BRCA1 or BRCA2 mutation
  -  personal history of heart disease
  -  >10% risk of carrying a BRCA1 or BRCA2 mutation

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

Clinical trial: Effect of Chemotherapy Administered Before Surgery on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Summary: The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

Detailed description: In this study, the investigators propose that persistent disseminated tumor cells (DTC) present after chemotherapy represent a unique subpopulation of all DTC, are predictors of a poor response to chemotherapy, and correlate with poor clinical outcome. The investigators hypothesize that chemotherapy-resistant DTC can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. In this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by DTC which are present after chemotherapy, 2) to compare the expression of these markers to that on DTC detected prior to chemotherapy, 3) to correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence, 4) to utilize biomarkers identified in Specific Aims 1 and 2 to isolate purified DTC for further molecular analysis.

Eligibility: Inclusion Criteria:
  -  Recently diagnosed with clinical stage II, III, or IV breast cancer
  -  Planning to undergo neoadjuvant chemotherapy; patients who have already completed neoadjuvant chemotherapy are also eligible
  -  Must >= 18 years of age
  -  If female, must not be pregnant
  -  Must be willing and able to sign informed consent document

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

Clinical trial: Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2

Summary: RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses HER2.
  PURPOSE: This clinical trial is studying the immune response in patients who have undergone vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.

Detailed description: OBJECTIVES:
  Primary
  -  Determine whether immunologic memory to the HER-2/neu (HER2) intracellular domain (ICD) protein has been generated by active immunization with a HER2 ICD plasmid-based vaccine by assessing the delayed-type hypersensitivity response to HER2 ICD peptides 6 months after vaccination in patients with HER2-overexpressing stage III or IV breast cancer.
  Secondary
  -  Characterize the memory T-cell population and quantitate memory precursor frequency at 3, 6, and 12 months after active immunization using intracellular cytokine staining.
  OUTLINE: This is an open-label study.
  Patients receive HER2 intracellular domain (ICD) protein mixture intradermally and sterile water injected intradermally (as a negative control) at 6 months post-vaccination with pNGVL3-hICD vaccine. Vital signs and injection site will be monitored prior to skin test and at 60 minutes post-test. Patients return 48-72 hours after skin test for delayed-type hypersensitivity (DTH) measurements. The injection site is biopsied and examined by immunohistochemistry for infiltrating T-cell and antigen-presenting cell populations.
  Blood is drawn at 3, 6, and 12 months post-vaccination for assessment of immune memory response. Blood draws are coordinated with parent study. Blood samples are examined by flow cytometry for the presence of memory markers including L-selectin, CD45 isoforms, cytokines, and CCR7.
  PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of stage III/IV breast cancer
  -  Completed chemotherapy
  -  Receiving trastuzumab (Herceptin®) monotherapy
  -  Successful completion of HER-2/neu (HER2) intracellular domain (ICD) plasmid-based vaccine trial (Protocol 01-9773-D06: "A Phase I Safety and Efficacy Trial of a DNA Plasmid Based Vaccine Encoding the HER-2/neu Intracellular Domain In Subjects With HER-2/neu-Overexpressing Tumors") within the past 3 months
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Male or female (male patients are not excluded)
  -  Menopausal status not specified
  -  Zubrod performance status 0
  -  Unable to bear children (female patients)
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No cytoreductive chemotherapy within the past 30 days
  -  No cytotoxic treatment and/or systemic corticosteroids within the past month
  -  Concurrent local radiotherapy or hormonal therapy allowed

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

Clinical trial: Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

Summary: The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).


Eligibility: Inclusion Criteria:
  -  Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
  -  Measurable disease defined according to RECIST
  -  ECOG performance status of 0 or 1
  -  Normal organ and marrow function
  -  No other malignancies within 5 years, except for non-melanoma skin cancer
  Exclusion Criteria:
  -  Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
  -  Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
  -  Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered > 30 days before study enrollment
  -  Receiving anticoagulation therapy with warfarin (low-dose warfarin < 1 mg/day, heparin and low molecular weight heparins are permitted)
  -  The subject meets any of the following cardiac criteria:
  -  Corrected QT interval (QTc) of > 460 msec
  -  Family history of congenital long QT syndrome or unexplained sudden death
  -  History of sustained ventricular arrhythmias
  -  Has a finding of left bundle branch block
  -  Has an obligate pacemaker
  -  Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node dysfunction
  -  Has uncontrolled hypertension
  -  Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
  -  Has a serum potassium or serum magnesium level that falls outside the normal range
  -  The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
  -  Uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Known HIV

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

Clinical trial: GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

Summary: This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.


Eligibility: Inclusion criteria:
  -  Patients with confirmed breast cancer who have received prior trastuzumab.
  -  Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
  -  Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
  Exclusion criteria:
  -  Patients with certain heart problems.

Relevance to patient case: not relevant