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

Clinical trial: HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

Summary: The combination of vinorelbine with weekly trastuzumab has produced high response rate in HER2 overexpressing metastatic breast cancer (MBC). The present phase 2 study was planned to test activity of the same combination, with trastuzumab given every 3 weeks, rather than weekly.

Detailed description: The schedule of treatment includes vinorelbine (30 mg/m2 on days 1 & 8 every 21 days) and trastuzumab (8 mg/kg on day 1 and then 6 mg/kg every 21 days). Vinorelbine is planned for maximum 9 cycles, while trastuzumab can be continued until progression. This study is a single-stage phase 2 design, and patients eligible for response evaluation are required.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed breast cancer
  -  Stage IV
  -  No prior or not more than one prior chemotherapy for metastatic disease
  -  Overexpression of HER-2 (3+ on immunohistochemical exam) or amplified genetic expression of c-erbB2/neu (positive by Fish method)
  -  Performance status 0-2 (ECOG)
  Exclusion Criteria:
  -  Absence of measurable disease
  -  Life expectancy < 3 months
  -  Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
  -  Previous treatment with trastuzumab or vinorelbine
  -  Neutrophils < 1500/mm3 or platelets < 100000/mm3 or haemoglobin < 8 g/dl
  -  Creatinine > 1.5 x the value of the upper normal limit
  -  GOT and/or GPT > 2.5 x the value of the upper normal limit and/or bilirubin > 1.5 x the value of the upper normal limit in the absence of liver metastases
  -  GOT and/or GPT > 5 x the value of the upper normal limit and/or bilirubin > 3 x the value of the upper normal limit in the presence of liver metastases
  -  Left ventricular ejection fraction < 50% (measured by ultrasound or MUGA angiography)
  -  Concomitant conditions that contraindicate the use of the drugs in the protocol
  -  Male gender
  -  Pregnancy or lactation·
  -  Incapacity or refusal to provide informed consent
  -  Inability to comply with followup

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

Clinical trial: Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

Summary: This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Female or male patients ≥18 years with WHO performance status ≤ 1
  -  HER-2 overexpressing metastatic breast cancer cells confirmed by histology
  -  Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy
  -  Patients neurologically stable with adequate bone marrow, liver and renal function
  Exclusion criteria:
  -  Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
  -  Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
  -  Patients who have previously received vinorelbine or mTOR inhibitors
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer

Summary: The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.

Detailed description: The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.

Eligibility: Inclusion Criteria:
  -  Histological or cytological diagnosis of breast cancer
  -  Stage IV disease
  -  None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
  -  Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
  -  ECOG Performance Status 0-2
  -  Age >18 and < 75 years
  -  Left Ventricular Ejection Fraction (LVEF) >50%
  -  Life expectancy >3 months
  -  Signed informed consent
  Exclusion Criteria:
  -  Absence of measurable or evaluable disease
  -  Life expectancy < 3 months
  -  ECOG performance status > 2
  -  History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
  -  Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
  -  Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted)
  -  Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl
  -  Creatinine > 1.5 x the upper normal limits
  -  GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper normal limits in absence of hepatic metastases
  -  GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper normal limits in presence of hepatic metastases
  -  Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia
  -  Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
  -  Male gender
  -  Pregnant or lactating women
  -  Refusal or incapacity to provide informed consent
  -  Inability to comply with follow up

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

Clinical trial: Lapatinib and Bevacizumab for Metastatic Breast Cancer

Summary: This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.


Eligibility: Inclusion criteria:
  -  Females that are at least 18 years of age.
  -  Women of childbearing potential must have a negative serum pregnancy test at screening.
  -  Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting.
  -  Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic.
  -  Adequate hepatic, renal and cardiac function
  -  ECOG score 0-1 and a life expectancy of at least 12 weeks.
  -  Able to swallow oral medication
  -  Signed informed consent
  Exclusion criteria:
  -  Pregnancy
  -  Unstable or symptomatic CNS metastases
  -  Major surgery within 28 days of enrollment (minor surgery within 7 days).
  -  Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities.
  -  A serious non-healing wound, ulcer, or bone fracture at baseline.
  -  Class II, III or IV heart failure as defined by the NYHA functional classification system
  -  History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension.
  -  History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment.
  -  History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
  -  History of malabsorption syndrome, ulcerative colitis, or bowel obstruction.
  -  Proteinuria
  -  Requires concurrent anti-cancer treatment or investigational treatment.
  -  Known hypersensitivity to either study medication
  -  Received investigational treatment within 28 days or 5 half-lives, whichever is longer
  -  Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study
  -  Requires medication that has been excluded during study participation

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

Clinical trial: Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer

Summary: RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.
  PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.

Detailed description: OBJECTIVES:
  -  Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
  -  Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
  -  Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.
  OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.
  All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed breast cancer
  -  Stage I or II disease (T1-T2, N0, M0/MX disease)
  -  No chest wall invasion by tumor (T3 disease)
  -  Medially or centrally located lesion
  -  No multicentric disease
  -  Multifocal disease allowed
  -  No clinically positive axillary nodes
  -  No enlarged internal mammary nodes by CT scan
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Male or female
  -  Menopausal status not specified
  -  American Society of Anesthesiologists (ASA) physical status classification 1-2
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  No other concurrent known, invasive malignancy
  -  No known chronic pulmonary disease
  -  No known allergy to methylene blue or isosulfan blue
  PRIOR CONCURRENT THERAPY:
  -  No prior thoracic or cardiac surgery
  -  No prior ipsilateral chest tube placement
  -  Contralateral chest tube placement allowed
  -  No prior neoadjuvant chemotherapy
  -  No prior radiotherapy to the mediastinum

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

Clinical trial: GW572016 In Patients With Advanced Or Metastatic Breast Cancer

Summary: This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.


Eligibility: Inclusion Criteria:
  -  Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
  -  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: definitely relevant
Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer

Summary: This is a pilot study to gather preliminary data on the baseline immunologic status of patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial.

Detailed description: This is a pilot study to gather preliminary data on the baseline immunologic status of patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial. We will ask up to 10 patients with HER-2(+) breast cancer in stable condition and in reasonable health to participate in this study. The study will establish an immune monitoring for correlative studies done in patients with HER-2(+) breast cancer. The immunologic tests that will be done are ELISpot, lymphocyte proliferation, intracellular cytokine staining, lymphocyte immunophenotyping, and ELISA.

Eligibility: Inclusion Criteria:
  -  Age >= 18 years of age
  -  Histologically documented breast cancer (hormone receptor (ER/PR) status may be either positive or negative) with or without metastatic disease.
  -  HER-2(+) as determined by one of the following measurements. NOTE: HER-2(+) assessment may have been on initial diagnosis and need not be repeated for metastatic lesions
  -  Immunohistochemistry (IHC) 3+, or
  -  FISH + (HER-2 gene signal to centromere 17 signal >2)
  -  No transfusion dependent patients and no transfusion within 30 days of leukopheresis
  -  Documented labs within 7 days of donation consisting of:
  -  WBC > 4.0 K/ul & < 11.0 K/ul
  -  platelet count > 150,000/mm3
  -  hemoglobin > 11.0 g/dl.
  -  Hematocrit > 33 %
  -  Weight > 110 lbs
  -  No blood donation in last 8 weeks (blood samples taken for standard of care less then 30 cc/week are acceptable)
  -  Patients must not have active or unresolved infection.
  -  No cold or flu sympton at time of donation
  -  No prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)
  -  All patients must give signed written informed consent.
  -  ECOG Performance Score of 0 or 1.
  -  Women of childbearing potential must have a negative serum or urine pregnancy test
  Exclusion Criteria:
  -  The presence of another active malignancy
  -  Pregnant, lactating, or nursing
  -  Patients with prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)

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

Clinical trial: High Risk Breast Cancer Screening Program

Summary: Objectives:
  -  To screen population with high risk for breast cancer
  -  To promote the concept and importance of surveillance mammography
  -  To find out the incidence of breast cancer in population who are in high risk for breast cancer
  -  To collect blood samples for molecular analysis


Eligibility: Inclusion Criteria:
  -  Female
  -  > 40 years of age
  -  Women who have first-degree relative suffered from breast cancer
  -  Women who have first-degree relative suffered from ovarian cancer
  -  Family history of male breast cancer
  -  Family history of breast cancer (not necessarily first degree relatives) diagnosed before age of 40
  -  Family history of breast cancer (not necessarily first degree relatives) affecting 2 or more family members
  -  Personal history of ovarian cancer
  -  Personal history of premalignant conditions of breast and ovary
  Exclusion Criteria:
  -  Women with mammogram within one year

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

Clinical trial: Nipple Areola Complex Conservation

Summary: 96 patients were offered a nipple sparing mastectomy.

Detailed description: 96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.

Eligibility: Inclusion Criteria:
  -  breast cancer
  Exclusion Criteria:
  -  inflammatory breast cancer
  -  clinical skin or nipple involvement

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

Clinical trial: APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)

Summary: This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.


Eligibility: Inclusion Criteria:
  -  Females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (HER2/neu+) breast cancer
  -  Have progressed after treatment with chemotherapy including a taxane and trastuzumab
  -  Must have measurable disease by RECIST
  -  ECOG PS of 0,1, or 2
  -  MUGA scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50%
  Exclusion Criteria:
  -  Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment
  -  Evidence of New York Heart Association class III or greater cardiac disease
  -  History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
  -  History of congenital QT prolongation
  -  Concurrent severe or uncontrolled medical disease
  -  Symptomatic central nervous system metastases
  -  Pregnant or nursing women
  -  Hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-FU, sulfonamides, aspirin, or NSAIDs
  -  Severe renal insufficiency
  -  History of upper GI bleeding, ulceration, or perforation- Concurrent use of potent CYP3A4 inhibitors and CYP3A4 inducers
  -  Prior treatment with capecitabine
  -  Patients on anti-arrhythmic treatment
  -  Prior lapatinib therapy

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

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: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer

Summary: This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.

Detailed description: A phase II trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity profile. Recently initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population.

Eligibility: Inclusion Criteria:
  -  Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
  -  No HER2 overexpression or gene amplification
  -  No previous therapy for metastatic breast cancer is allowed
  -  Age 18-75 years
  -  At least 12 months interval since prior adjuvant therapy with taxanes and/or anthracyclines
  -  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 UNL in the presence of liver metastases)
  -  Adequate renal function (serum creatinine <1.5 times the upper normal limit
  -  Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
  -  Written informed consent
  Exclusion Criteria:
  -  Active infection
  -  Brain metastases
  -  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