araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer

Summary: The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET) blocks.

Detailed description: This study is done to gather preliminary data for determining the best way to test EGFR expression in patients with cervical cancer who will receive treatment with EGFR inhibitors in the future.
  This study is designed to obtain preliminary data of genomic and phenotypic alterations of the EGFR pathway in high grade cervical intraepithelial lesions (HG-SIL) and invasive cervical cancers (CC) to be used later for therapeutic guidance and to evaluate genomic (over-expression, amplification, point mutations, etc.) and phenotypic alterations of other transduction pathways interacting with the EGFR pathway.

Eligibility: Inclusion Criteria:
  -  Samples from patients diagnosed with HG-SIL (n=300) and CC (n=300) with a follow-up of at least 24 months, existing at the Department of Pathology will be retrieved by the Tissue Repository, de-identified them and provided with code numbers that will not be linked to patient's data.
  Exclusion Criteria:
  -  None Specified.

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

Summary: A Phase I Study of Adjuvant Topotecan and Cisplatin with Concurrent Radiation Therapy for Advanced Cervical Cancer.

Detailed description: Examines the effects of Topotecan and Cisplatin with radiation for advanced cervical cancer

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed advanced cervical carcinoma who, following optional surgical staging, are not deemed to be curable by either surgery or radiotherapy alone. This includes patients with stages IIB, IIIA, IIIB or IVA and stages IB or IIA who in addition have one of the following risk factors:
  -  Primary tumor > 6 cm
  -  Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
  -  Positive surgical margins
  -  Depth of invasion greater than 50 % and positive capillary-lymphatic space involvement
  -  Eligible cell types include squamous, adenosquamous and adenocarcinoma of the cervix
  -  Patients may have measurable disease (defined as lesions which can be measured in at least two (2) dimensions by physical examination or any medical imaging technique). Inability to measure disease will not constitute exclusion criteria.
  -  Patients with GOG performance status of 0, 1, or 2.
  -  Patients will have recovered from the effects of recent surgery and should be free of clinically significant infection.
  -  Patients must have adequate:
  -  Bone marrow function: WBC greater than or equal to 3,000 cells/mm3, platelet count greater than or equal to 100,000 cells/mm3, and granulocyte count greater than or equal to 1,500 cells/mm3.
  -  Renal function: Creatinine less than or equal to 2.0 mg/dl.
  -  Hepatic function: Bilirubin less than or equal to 1.5 x institutional normal, SGOT and alkaline phosphatase less than or equal to 3 x institutional normal.
  -  Patients must have signed an approved informed consent.
  -  Patients have met the pre-entry requirements specified in Section 7.0
  Exclusion Criteria:
  -  Patients with GOG performance of 3 or 4.
  -  Patients with another malignancy, prior or concomitant, other than skin (excluding melanoma).
  -  Patients with septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction.
  -  Patients with anatomic abnormalities requiring modification of radiation fields (pelvic kidney, renal transplant, etc.).
  -  Patient with recurrent cervical cancer
  -  Patients who have received prior pelvic radiation
  -  Pregnant women and women of childbearing potential not using an effective form of contraception.
  -  History of thrombus (10/28/02)
  -  History of unstable angina or MI within the past six months. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months. (10/28/02)

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

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: possibly relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

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 cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

Summary: This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.


Eligibility: Inclusion criteria:
  -  Clinical labs are within acceptable ranges.
  -  A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
  -  At least 18 years of age.
  -  Females must meet certain criteria specified in protocol.
  -  Ability to swallow and retain oral medication.
  -  Ability to follow and understand directions.
  Exclusion criteria:
  -  Female who is pregnant or lactating.
  -  Medically unfit by the doctor as a result of the medical interview or physicals.
  -  Received treatment of an investigational drug within 4 weeks of study start.
  -  Currently receiving treatment with prohibited meds listed in protocol.
  -  Had major surgery in previous 2 weeks.
  -  Had prior radiation therapy to the chest to treat this incidence of breast cancer.
  -  Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
  -  Has a malabsorption syndrome.

Relevance to patient case: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

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 cervical cancer; genetic feature: ERBB2 (S310Y)

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 cervical cancer; genetic feature: ERBB2 (S310Y)

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
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

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: not relevant
Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

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