araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: V930 First in Man (FIM) Study (V930-002)(COMPLETED)

Summary: To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.


Eligibility: Inclusion Criteria:
  -  Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
  -  Patients will either be disease free following primary therapy or have advanced disease with a durable response (>3 months) after standard therapy
  -  Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis
  Exclusion Criteria:
  -  Patients with prior treatment with any HER-2 and/or CEA containing vaccine
  -  Patients who have significant cardiac disease
  -  Patients with autoimmune disorders
  -  Patients who are pregnant or lactating

Relevance to patient case: definitely relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer

Summary: To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered

Detailed description: 1. To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2/neu positive metastatic breast cancer
  2. To enhance the proportion of complete remission
  3. To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity

Eligibility: Inclusion Criteria:
  -  HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test
  -  Female < 70yrs
  -  Histologically or cytologically proven breast cancer.
  -  Metastatic or locally advanced breast cancer (clinical stage: III-IV)
  -  Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50%
  -  Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2
  Exclusion Criteria:
  -  History of cardiopathy
  -  Severe hepatic and renal diseases
  -  Brain metastases as the only parameter of disease
  -  Contraindication to the use of corticosteroids as premedication
  -  Acute infectious diseases
  -  Insulin-dependent diabetes
  -  History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
  -  Concurrent treatment with any other cancer therapy

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Summary: Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.


Eligibility: Inclusion criteria:
  -  Signed Informed Consent
  -  ErbB2(HER2)overexpressing breast cancer.
  -  Brain lesion(s) which are progressing.
  -  Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).
  -  Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.
  -  Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.
  -  Able to swallow an oral medication.
  -  Adequate kidney and liver function.
  -  Adequate bone marrow function.
  Exclusion criteria:
  -  Pregnant or lactating females.
  -  Conditions that would effect the absorption of an oral drug.
  -  History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
  -  Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
  -  Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Study of XL647 Administered Orally Daily to Patients With Solid Tumors

Summary: The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Subject has histologically confirmed malignancy that is metastatic or unresectable
  -  Subject has disease that is assessable by tumor marker, physical, or radiologic means
  -  Subject is at least 18 years old
  -  Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
  -  Subject has a life expectancy ≥ 3 months
  -  Subject has normal organ and marrow function
  -  Subject gives written informed consent
  -  Subject must use an accepted method of contraception during the study
  -  Female subjects of childbearing potential must have a negative pregnancy test
  Exclusion Criteria:
  -  Subject has received anticancer treatment within 30 days of first dose of XL647
  -  Subject has received another investigational agent within 30 days of first dose of XL647
  -  Subject has known brain metastases
  -  Subject has corrected QT interval (QTc) of > 0.45 seconds
  -  Subject is currently receiving anticoagulation therapy with warfarin
  -  Subject has uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Subject has known HIV

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

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: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

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: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

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: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer

Summary: RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on brain function may help doctors plan cancer treatments.
  PURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and radiation therapy in patients with colon cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Identify the nature and long-term ramifications of CNS injury as a result of cancer treatment in patients with colon cancer.
  Secondary
  -  Analyze differences in cognitive measures and MRI data in these patients.
  -  Correlate MRI measures with cognitive performance in these patients.
  OUTLINE: Patients undergo cognitive performance assessment and MRI.
  PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer
  -  Received chemotherapy and radiotherapy for colon cancer
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

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: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

Summary: This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.

Detailed description: Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.

Eligibility: Inclusion Criteria:
  -  Performance status (WHO) 0-2
  -  Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
  -  HER-2 overexpression 2+ or 3+ using IHC or FISH +
  -  Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
  -  No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
  -  More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
  -  No prior first line chemotherapy for metastatic disease
  -  Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
  -  Paraffin block from the primary tumor available in the research lab
  -  Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
  -  Adequate liver (Bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  -  Adequate cardiac function (LVEF > 50%)
  -  Informed consent
  Exclusion Criteria:
  -  Pregnant or nursing
  -  Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
  -  Positive pregnancy test
  -  Motor or sensory neuropathy > grade 1 according to NCIC Τoxicity Criteria
  -  Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
  -  History of allergic reaction attributed to docetaxel
  -  Psychiatric illness or social situation that would preclude study compliance
  -  Other concurrent uncontrolled illness.
  -  Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ

Relevance to patient case: not relevant