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

Clinical trial: Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment

Summary: Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high frequency of EGF-R expression. EGFR is an important regulator of tumour progression and proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the investigators hypothesise that EGFR signalling pathway and its interactions play an important role in the SCC pathogenesis and represent a good therapeutic target from these tumours.
  Primary Objectives:
  To evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK).
  Secondary Objectives:
  -  To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period.
  -  To investigate the molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables.
  -  Trial with medicinal product


Eligibility: Inclusion criteria:
  -  Age ≥ 18 years
  -  Diagnosis of histologically confirmed cutaneous SCC stage Tis-T2N0 for which surgical treatment is considered suitable.
  -  In case of SCC, patients must present with a minimum of two co-existing AK lesions. In case of Keratoacanthoma, one lesion of sufficient size (=1cm) is acceptable.
  -  All included patients must have both FFPE and frozen material available.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Adequate organ system function
  Exclusion criteria:
  -  Subjects who have current active hepatic or biliary disease
  -  Other non-controlled malignancy
  -  Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
  -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study treatment.
  -  Presence of uncontrolled infection
  -  History of any one or more of the following cardiovascular conditions within the past 6 months:Cardiac angioplasty or stenting;Myocardial infarction;Unstable angina;Coronary artery bypass graft surgery;Symptomatic peripheral vascular disease; Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  -  Poorly controlled hypertension
  -  History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  -  Prior exposure to the study drug lapatinib
  -  Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer

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

Clinical trial: Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

Summary: Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.


Eligibility: Inclusion Criteria:
  -  NSCLC confirmed by histopathology or cytology;
  -  Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
  -  Has active mutation of EGFR in exon 19 or 21;
  -  Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  -  expectancy life >= 12 weeks;
  Exclusion Criteria:
  -  Had be treated by HER-targeting agents;
  -  Had systemic anit-NSCLC treatments;
  -  Had local radiotherapy for NSCLC;
  -  Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
  -  Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
  -  Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
  -  Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
  -  Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

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

Clinical trial: Europe-Japan Diagnostic Study for EGFR Testing

Summary: This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.

Detailed description: A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing,

Eligibility: Inclusion Criteria:
  -  Patients aged 18 years and older in Europe and aged 20 years and older in Japan
  -  Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC.
  -  Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
  -  Provision of diagnostic cancer tissue or cytology sample upon inclusion
  -  Provision of a routine blood sample
  Exclusion Criteria:
  -  Evidence of severe or uncontrolled systemic disease
  -  Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
  -  Pregnancy or breast-feeding

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

Clinical trial: A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

Summary: This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination. The cisplatin combination expansion portion will evaluate the anti tumor activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).


Eligibility: Inclusion Criteria:
  Cisplatin Combination Expansion:
  Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the metastatic setting.
  -  Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell lunch cancer that are candidates for treatment with a docetaxel-based combination.
  -  Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian cancer or non small cell lunch cancer that are candidates for a cisplatin-based combination.
  -  Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+ esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch cancer that are candidates for treatment with a dacomitinib-based combination.
  -  Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
  -  Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.
  -  Adequate bone marrow, renal and liver function.
  Exclusion Criteria:
  -  Prior therapy for Cisplatin Combination Expansion:
  -  Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic setting;
  -  Prior radiation to >25% bone marrow as estimated by the Investigator.
  -  Patients with known symptomatic brain metastases.
  -  Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the lead-in dose.
  -  Major surgery within 4 weeks of the baseline disease assessments.
  -  >2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.
  -  Active bacterial, fungal or viral infection.
  -  Uncontrolled or significant cardiovascular disease.

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

Clinical trial: Neratinib HER Mutation Basket Study (SUMMIT)

Summary: This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti-cancer therapy.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  -  Pediatric patients (at least 12 but less than 18 years of age at signing of informed consent) may be recruited in the Fibrolamellar Carcinoma cohort.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER tyrosine kinase inhibitor (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

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

Clinical trial: Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation

Summary: This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;advanced (stage IIIB/IV)non-small cell lung cancer;measurable disease;ECOG Performance Status 0-2.
  Exclusion Criteria:
  -  prior exposure to agents directed at the HER axis;prior chemotherapy or systemic anti-tumor therapy after advanced disease;unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix.

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

Clinical trial: Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

Summary: The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.

Detailed description: This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.

Eligibility: Inclusion Criteria:
  -  Willing and able to provide informed consent;
  -  Postmenopausal;
  -  Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal;
  -  Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed;
  -  Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report;
  -  Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible;
  -  Eastern Cooperative Oncology Group (ECOG) status of 0 or 1;
  Exclusion Criteria:
  -  Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator;
  -  Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator;
  -  Current or previously treated brain metastasis or leptomeningeal disease;
  -  Prior therapy (> 28 days) with exemestane in the metastatic setting (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible);
  -  Requires treatment for tuberculosis or HIV infection;
  -  Radiation therapy within 7 days before randomization;
  -  History of another invasive cancer within 5 years before randomization;
  -  History of seizure or any condition that may predispose to seizure;
  -  Clinically significant cardiovascular disease;
  -  Active gastrointestinal disorder;
  -  Major surgery within 28 days prior to randomization;
  -  Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization;
  -  Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor;
  -  Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides;
  -  Hypersensitivity reaction to exemestane.

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

Clinical trial: A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

Summary: This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.

Detailed description: Safety evaluation.

Eligibility: Inclusion Criteria:
  -  Body Mass Index (BMI) of 17.5 to 30.5 kg^m2; and a total body weight >50 kg (110 lbs).
  -  Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
  -  Subjects who have previously been exposed to a biologic agent (other than a HER2 inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug.
  Exclusion Criteria:
  -  Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  -  Previous exposure to an anti-HER2 antibody.
  -  History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.

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

Clinical trial: Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Summary: Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phaseⅡtrial is designed to assess the resection rate and pathological complete response of nimotuzumab plus carboplatin and paclitaxel in patients with cervical cancer.


Eligibility: Inclusion Criteria:
  1. Age:18-70 years
  2. Histological confirmed Cervical squamous cell carcinoma
  3. FIGO Stage: IB2-IIIB
  4. Tumor lesions and stages are confirmed by the internal medicine, obstetrics and gynecology inspection, including a pelvic exam and abdominal and pelvic CT,.if necessary, laparoscopy, cystoscopy and pelvic MRI examination will be taken.
  5. At least one lesions can be measured
  6. No previous therapy
  7. ECOG performance status 0-2
  8. Life expectancy of more than 6 months
  9. Normal hematology:Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L, normal renal function: serum creatinine<1.5mg/dl or creatinine clearance rate>60ml/min；normal liver function:TBIL≤1.5 ULN, AST and ALT≤1.5 ULN
  10. Without lung or heart disease
  11. Without active infection
  12. Signed informed consent and submit to the organization of research
  Exclusion Criteria:
  1. Severe systemic or uncontrolled disease, unfit for chemotherapy
  2. Neuropathy caused by any reason
  3. Psychiatric disease
  4. Other malignant tumor
  5. Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level
  6. Infection and severe systemic disease
  7. Received other anti EGFR monoclonal antibody treatment
  8. Participation in other interventional clinical trials
  9. Allergic constitution or history of drug allergy
  10. Pregnant or breast-feeding or refused to take contraceptive method
  11. Poor compliance

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

Clinical trial: A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants

Summary: This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).


Eligibility: Inclusion Criteria:
  -  Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
  -  HER2-positive disease
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Hormonal therapy will be allowed as per institutional guidelines
  -  Prior use of anti-HER2 therapy will be allowed
  -  Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
  -  No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
  -  Use of concurrent radiotherapy will be permitted
  -  Completion of surgery and chemotherapy (if applicable)
  Exclusion Criteria:
  -  History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for the last 5 years
  -  Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
  -  Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
  -  Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
  -  Pregnant or lactating women
  -  Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
  -  Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
  -  Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
  -  Inadequate hepatic or renal function

Relevance to patient case: not relevant