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

Clinical trial: Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib

Summary: The purpose of this study is to understand how information of 3 specific biomarkers can provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.


Eligibility: Inclusion Criteria:
  1. HER2-positive (defined as either (a) IHC3+ or (b) FISH+ in local lab) recurrent / metastatic breast cancer patients who have received treatment with lapatinib-based regimen. These are either new, current or completed cases from any of the following settings:
  -  treated according to physician's clinical judgement in routine practice; or
  -  treated in clinical trials with known allocation to lapatinib-based regimen; or
  -  treated via lapatinib expanded access or named patient programs. These regimens should contain lapatinib as the only anti-HER2 agent.
  2. Exposed to < 2 lines of trastuzumab-based regimen in the metastatic setting prior to start of lapatinib-based regimen. These regimens should contain trastuzumab as the only anti-HER2 agent.
  3. Patients with an historical tumor biopsy specimen available from their primary breast cancer diagnosis. If this is not available, then at least a specimen should be available anytime during the period before the patient started on any anti-HER2 therapy.
  4. Willing to give written informed consent to release the tumor biopsy specimen with corresponding clinical data. If consent could be waived according to institutional practice (eg. patient already deceased, or patient previously provided blanket consent for institution to utilize tissue/data for research purpose), this is accepted with appropriate supporting documentation.
  Exclusion Criteria:
  1. Patients who have been exposed to other experimental anti-HER2 therapy eg. pertuzumab, trastuzumab-DM, neratinib, ertumaxomab, AV-412, BIBW2992, CUDC-101, anti-HER2 vaccines.
  2. Other primary lesions that are not of breast origin.

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

Clinical trial: Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

Summary: The purpose of this study is to determine whether laparoscopic radical hysterectomy for early cervical cancer will has decreased postoperative pain intensity compared to abdominal radical hysterectomy with similar postoperative complications and survival rates.

Detailed description: Background: Radical hysterectomy with pelvic lymphadenectomy is one of the FIGO (International Federation of Gynecology and Obstetrics) recommended treatments for early cervical cancer. The objective of this study was to compare radical hysterectomy by laparoscopic approach and open radical hysterectomy in a single center randomized clinical trial. Nevertheless, there are no finished randomized controlled trials comparing laparoscopic radical hysterectomy and abdominal radical hysterectomy although there is an ongoing trial.
  Methods: Were enrolled 30 IA2 with lymph vascular space invasion and IB cervical cancer patients. Postoperative pain intensity was defined as primary endpoint and pain intensity was measured by a 10-point numeric rating scale. Secondary outcomes were: intraoperative and other postoperative outcomes, histopathological outcomes and 5-year follow-up. Data analysis is being done at this moment

Eligibility: Inclusion Criteria:
  -  Women of 18 years or older referred to our service with histologically confirmed primary squamous, adenocarcinoma or adenosquamous cervical cancer diagnosed by biopsy or cervical conization, clinically FIGO (International Federation of Gynecologic and Obstetrics) staged IA2 with lymph vascular invasion, IB and II A.
  Exclusion Criteria:
  -  Patients with clinically advanced disease (IIB-IV), previous pelvic or abdominal radiotherapy, pregnancy, clinical diseases that would preclude one or both surgical approaches.

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

Clinical trial: Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma

Summary: This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.


Eligibility: Inclusion Criteria:
  -  Histologic diagnosis of nasopharyngeal carcinoma
  -  Range from 18～69 years old
  -  T3-4，N0-2，M0 (AJCC 2009)
  -  KPS ≥ 80
  -  Nonmetastatic diseases
  -  WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
  -  ALT or AST ＜ 1.5×ULN、bilirubin ＜ 1.5×ULN
  -  0Serum creatinine ＜ 1.5×ULN
  Exclusion Criteria:
  -  Distance metastases
  -  Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy)
  -  Second malignancy within 5 years
  -  Precious therapy with an investigational agent
  -  Uncontrolled seizure disorder or other serious neurologic disease
  -  ≥ Grade Ш allergic reaction to any drug including in this study
  -  Clinically significant cardiac or respiratory disease
  -  Creatinine clearance < 30ml/min
  -  Drug or alcohol addition
  -  Do not have full capacity for civil acts
  -  Severe complication, active infection
  -  Concurrent immunotherapy or hormone therapy for other diseases
  -  Pregnancy or lactation

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

Clinical trial: Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.
  Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  histologically/cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus - Unacceptable ocular/retinal conditions
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Role of Early Versus Late Switch to Lapatinib-Capecitabine

Summary: The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).

Detailed description: All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting can participate in this observational study, for a period of 12 months of observation since the start of the lapatinib-capecitabine treatment.

Eligibility: -  Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice);
  -  Older than 18 years old;
  -  Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer;
  -  Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment;
  -  Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, in the community setting;
  -  Signed consent to participate and release information for this study.

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

Clinical trial: TrasGEX™: Dose Escalation Study

Summary: This is a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response will also be evaluated.


Eligibility: Main Inclusion Criteria:
  1. Signed written informed consent granted prior to initiation of any study-specific procedures;
  2. Male or female patients of ≥18 years of age;
  3. ERBB2 (HER-2) gene amplification or ERBB2 overexpression
  4. Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
  5. No anti-tumor therapy of proven benefit available at study enrollment;
  6. Life expectancy of >=3 months;
  7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;
  8. Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™;
  9. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™;
  and
  Main Exclusion Criteria:
  1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
  2. Major surgery within four weeks of the first dose of TrasGEX™;
  3. Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required;
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
  5. History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
  6. History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™;
  7. Left ventricular ejection fraction <50%;
  8. Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
  9. Pregnancy or lactation; and
  10. Concurrent uncontrolled significant illness

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

Clinical trial: Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Summary: The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.

Detailed description: Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.
  Anthracycline-based regimen (d1, q3w):
  EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)
  Nab-paclitaxel 260mg/m2 (d1, q3w)
  Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed invasive breast cancer
  -  T1c-3 N0-2a
  -  Confirmed of hormonal receptor status
  -  HER2 positive confirmed by IHC 3+ or FISH+
  -  LVEF > 50% by echocardiogram or MUGA
  -  Adequate EKG
  -  No prior treatment for breast cancer
  -  PS 0-1
  -  Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl
  -  Written informed consent
  Exclusion Criteria:
  -  With history of hypersensitivity reaction for important drug in this study
  -  With history of invasive breast cancer
  -  Bilateral invasive breast cancer
  -  Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
  -  Positive for HBs antigen and with history of HVB
  -  With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
  -  With severe edema
  -  With severe peripheral neuropathy
  -  With severe psychiatric disorder
  -  Pregnant or nursing women
  -  Cases who physician judged improper to entry this trial

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

Clinical trial: Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer

Summary: Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

Detailed description: This is a Phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an AI in adult subjects with HR+, HER2-negative MBC. This study has 2 phases: a dose-evaluation phase (Phase 1b) and a randomization phase (Phase 2).

Eligibility: Inclusion Criteria:
  -  Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy
  -  Tumors are positive for ER, PgR, or both
  -  Tumors must be negative for HER2 (by FISH, CISH or IHC)
  -  Female gender and age ≥ 18 years at time of study entry
  -  Postmenopausal
  -  Karnofsky Performance Status ≥ 70
  -  Life expectancy of ≥ 6 months
  Exclusion Criteria:
  -  Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:
  -  Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573
  -  Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
  -  Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)
  -  Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573
  -  Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
  -  Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ Grade 1 at the time of starting study treatment
  -  Previous treatment with agents that target the IGF receptor
  -  History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI
  -  History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix
  -  Poorly controlled diabetes mellitus

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

Clinical trial: Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer

Summary: Rationale
  Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning.
  Purpose
  Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer.
  To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.

Detailed description: OBJECTIVES:
  To compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by adjuvant treatment.
  To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)).
  To determine the relationship between the biological variables (hormone receptor status, grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these patients.
  OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment arms.
  Arm 1: patients undergo conservative surgery with axillary lymphnodes removal Arm 2: patients undergo conservative surgery without axillary lymphnodes removal Post-operative adjuvant strategy was previously described.
  Patients are followed every 4 months for the first two years, every 6 months for the following two years, and then annually thereafter.
  PROJECT ACCRUAL 600 patients will be accrued for this study over 4 years
  ELIGIBILITY Ages eligible for study: 18-65 years Genders eligible for study: female

Eligibility: Inclusion Criteria:
  -  women with T1N0M0 invasive breast cancer
  -  18-65 years
  Exclusion Criteria:
  -  bilateral breast cancer
  -  no other prior or concurrent malignancy except basal cell carcinoma

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

Clinical trial: Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

Summary: The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

Detailed description: CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding CMAB009 to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.

Eligibility: Inclusion Criteria:
  -  histologically confirmed metastatic colorectal adenocarcinoma
  -  KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
  -  has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
  -  ECOG performance status 0 to 1
  -  Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve
  Exclusion Criteria:
  -  Previous irinotecan or anti-EGFR therapies
  -  hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
  -  liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
  -  Renal function: serum creatinine, more than 1.5 times the upper limit of normal
  -  Patients with symptomatic central nervous system metastases

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

Clinical trial: Cervical Cancer Screening Project Part C

Summary: This proposal has been developed through collaboration between the University of Minnesota and New American Community Services (NACS), and the research design is based on a needs assessment conducted by the community partner. The investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based Pap test. All participants will be given identical education materials on cervical cancer screening and HPV, currently in use by the Minnesota Sage Program.

Detailed description: The trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (HPV) testing for cervical cancer screening. The main objective is to estimate the successful screening completion rate among a sample of Somali women who have not undergone cervical cancer screening for three or more years. Women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based Pap test.

Eligibility: Inclusion Criteria:
  -  Somali female age 25-70 years
  -  have lived in the U.S. 10 years or less
  -  have not had a Pap test (by self report) in the last 3 years
  Exclusion Criteria:
  -  Women with a self reported past history of any of the following will not be eligible:
  -  total hysterectomy
  -  cervical cancer
  -  active history of cervical dysplasia

Relevance to patient case: not relevant