araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients

Summary: Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical issue. There are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary cancers for a range of pathologic and molecular factors, including tumor grade and histologic appearance. Several studies have shown that the response to treatment for women with a BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the impairment of the DNA damage response and repair pathways, and that it is possible to exploit the sensitivity of BRCA1-associated cancers to DNA damage.
  It is equally important that the investigators evaluate the benefit of cisplatin in women with disseminated breast cancer, including those who have previously been treated with one or more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast cancer. The secondary objectives are to determine 3-year survival and to evaluate the toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.


Eligibility: Inclusion Criteria:
  -  Female patients aged ≥ 18 years, with measurable (defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14)) metastatic (stage IV) breast cancer, and who are known to carry a BRCA1 mutation, are eligible.
  -  In addition, the following are required:
  -  adequate hematologic
  -  renal, and hepatic function
  -  adequate recovery from recent surgery and/or radiation therapy
  -  recovery from all prior treatment-related toxicities (to grade < 2 according to National Cancer Institute Common Toxicity Criteria, Version3.0, except alopecia)
  -  life expectancy of at least 12 weeks
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. -
  -  Patients could have received up to four prior chemotherapies for metastatic disease.
  Exclusion Criteria:
  -  Patients with known brain metastases are not eligible.
  -  Patients previously treated with a platinum-based chemotherapy are not eligible.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

Summary: In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. The internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is carried out to improve the visualization rate of IMSLN with modified techniques: (1) The radiotracer is injected intraparenchymally into 2~4 quadrants of breast. (2) The radiotracer is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic guidance.

Detailed description: OBJECTIVES:
  -  Compare the visualization rate of internal mammary sentinel lymph node in breast cancer patients with different injection technologies.
  -  Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node -negative in these patients.
  -  Evaluate the risk factors for internal mammary sentinel lymph node metastasis
  -  Evaluate the success rate and the safety of internal mammary sentinel lymph node biopsy.
  -  Draw the learning curve of internal mammary sentinel lymph node biopsy.
  OUTLINE:
  3~18 hours before surgery, 99mTc-labeled sulfur colloid was injected under ultrasonographic guidance in different patterns and injection methods were classified according to the number of injection quadrants. Subsequently, lymphoscintigraphy was performed 0.5~1.0 hour before surgery. During surgery, the sentinel lymph nodes (axillary or internal mammary) were identified by combining the use of intraoperative gamma detector and blue dye. The sentinel lymph nodes (axillary or internal mammary) were analyzed by hematoxylin-eosin staining and immunohistochemistry for future therapy planning.

Eligibility: Inclusion Criteria:
  -  primary breast cancer
  -  clinically axilla-negative
  Exclusion Criteria:
  -  enlarged internal mammary nodes by imaging

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy

Summary: - The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.


Eligibility: Inclusion Criteria:
  -  HER2-negative breast cancer patients
  -  Without surgery
  -  Plans to neoadjuvant chemotherapy
  Exclusion Criteria:
  -  HER2-positive breast cancer patients
  -  Post-operative patients

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive

Summary: In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.

Detailed description: OBJECTIVES:
  -  Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan.
  -  Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive.
  -  Draw the learning curve of internal mammary sentinel lymph node biopsy.
  OUTLINE:
  3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.

Eligibility: Inclusion Criteria:
  -  primary breast cancer
  -  clinically axilla-positive
  Exclusion Criteria:
  -  enlarged internal mammary nodes by imaging

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer

Summary: This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.
  The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed invasive breast carcinoma
  -  Stage T1-3,N0 evaluated by physical exam or imaging according to AJCC v.7 and best clinical local practices
  -  Intraoperative evaluation of sentinel lymph node (SLN) by OSNA
  -  Complete dissection of axillary lymph nodes after the evaluation of the SLNs by OSNA
  -  Pathology report of the tumor and dissected lymph nodes that includes the following information:
  -  primary tumor size (mm), tumor grade (Scarff-Bloom Richardson), estrogen receptor status
  -  progesterone receptor status
  -  HER2 status (ASCO/CAP guidelines)
  -  Ki67 index
  -  presence/absence of lymphovascular invasion
  -  total number of sentinel and non-sentinel lymph nodes dissected during surgery
  -  total number of positive and negative sentinel and non-sentinel lymph nodes, *size of the metastasis in both sentinel and non-sentinel lymph nodes
  -  total tumoral load in each sentinel lymph node, expressed as number of CK19 mRNA copies per microliter.
  Exclusion Criteria:
  -  Patients who underwent neoadjuvant chemotherapy
  -  CK19-negative breast tumor
  -  ALND with <10 lymph nodes
  -  In situ carcinoma only
  -  Metastatic breast cancer at time of diagnosis

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Summary: The purpose of this study is to find out if combining everolimus with letrozole is safe and has beneficial effects in postmenopausal women who have estrogen positive HER2 negative locally advanced or metastatic breast cancer. Additionally, this study aims to find out if everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole. This study will also aim to find out if a mouth rinse can help reduce the severity of oral stomatitis, a common side effect of everolimus. This part of the study will be conducted only in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially available.


Eligibility: Inclusion Criteria:
  -  Patients 18 years old or greater
  -  Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
  -  Histological or cytological confirmation of estrogen-receptor positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer
  -  Postmenopausal women
  -  No prior treatment for metastatic breast cancer
  Exclusion Criteria:
  -  Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
  -  Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
  -  Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
  -  Previous treatment with mTOR inhibitors.
  -  Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
  -  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer

Summary: Breast cancer is a heterogeneous disease and can be classified into several distinctive subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER), progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2) overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its aggressive clinical behavior and insensitivity toward available targeted treatment strategies such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early relapse with metastatic disease is common and the prognosis is poor. Development Of novel treatment strategies is,therefore,needed and the study of other potential targets in TNBC,like tyrosine kinase receptors,is a topic of interest.
  Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR mutation was rare in TNBC.
  By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one or more limitations including:1) the study population had received heavily pretreatment; 2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR was not clear in the enrolled patients.
  Here, the investigators launch a prospective clinical trial, and about 50 patients with triple-negative,EGFR positive metastatic breast cancer that have received at least second line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in the metastatic TNBC.


Eligibility: Inclusion Criteria:
  -  ≥18 years of age
  -  ≥1 measurable or assessable lesion
  -  Eastern Cooperative Oncology Group(ECOG)performance status of 0-2
  -  adequate renal,hepatic and hematological function
  -  a life expectancy of >12 weeks
  -  histologically proven EGFR positive metastatic TNBC
  Exclusion Criteria:
  -  brain metastasis

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors

Summary: To see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase inhibitors in postmenopausal patients with early breast cancer in terms of:
  i) Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall survival

Detailed description: The relationship between obesity and breast cancer is a complex one. Obesity is a risk factor for the development of breast cancer in postmenopausal women and has been linked to an increased risk of recurrence and decreased survival as compared to patients with normal weight.
  The hypothesis that led to this study is that the amount of total-body aromatization capacity indicated by body mass index (BMI). In postmenopausal women and in premenopausal women with ovarian suppression, the major source of serum estrogens is the fat tissue, in which precursors are metabolized to estrogens by the enzyme aromatase. Thus, an increase in BMI leads to an increase in total-body aromatization and, consequently, an increase in oestrogen serum levels, which impact on breast cancer. Taken together, this suggests that BMI may serve as a useful surrogate parameter for total-body aromatization and eventually may be a practicable tool to tailor aromatase inhibitors (AIs) therapy for individual patients.
  The study will include 360, postmenopausal patients with early breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (ER) and/or progesterone receptor (PR). Patients will be randomly assigned to receive tamoxifen 20 mg once daily or AIs (letrozole 2.5mg/ anastrozole 1mg/exemestane 25mg) once daily for five years. Patients with a tumour stage IB, IC, or II irrespective of nodal stage (<10 positive nodes) will be included. Weight and height will be taken at baseline for calculation of BMI according to the WHO criteria. The frequency of adverse events will be used to assess safety throughout the study.
  The primary end point will be disease-free survival (DFS). Secondary end points will be recurrence-free survival and overall survival (OS). The data will be analyzed for DFS and OS according to the BMI subgroups as well as two treatment arms (tamoxifen v AIs). The frequency of adverse events will be used to assess safety throughout the study.

Eligibility: Inclusion Criteria:
  -  postmenopausal patients with breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (ER) and/or progesterone receptor (PR).
  -  patients with a tumour stage IB, IC, or II irrespective of nodal stage (< 10 positive nodes)
  Exclusion Criteria:
  -  premenopausal patients,
  -  ER/PR negative

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

Summary: The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

Detailed description: The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)
  RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.

Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of metastatic colorectal adenocarcinoma
  -  a wild-type RAS tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of KRAS exons 2, 3, and 4, and NRAS exons 2, 3, and 4
  -  Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
  -  Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment.
  -  Age at least 18 years
  -  ECOG Performance Status 0-2
  -  Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dL
  -  Bilirubin level less than 1.5 times ULN
  -  AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)
  -  Serum creatinine less than 1.5 times ULN
  -  Effective contraception, if the risk of conception exists
  -  Life expectancy at least 3 months
  -  Written informed consent
  Exclusion Criteria:
  -  Symptomatic brain metastasis
  -  Interstitial pneumonitis or pulmonary fibrosis
  -  Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
  -  Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications
  -  Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment

Relevance to patient case: not relevant
Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: The Prone Breast Radiation Therapy Trial

Summary: Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size.
  After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life.
  This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.

Detailed description: The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.

Eligibility: Inclusion Criteria:
  -  confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS);
  -  treated with BCT;
  -  no indication for treatment of regional LN;
  -  Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater
  Exclusion Criteria:
  -  Regional Lymph Node XRT indicated;
  -  Bilateral breast cancer;
  -  unhealed wound (skin not closed and/or infection);
  -  previous XRT to the same breast;
  -  unable to lie prone;
  -  presence of active connective tissue disease;
  -  pregnancy;
  -  unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy > 10%);
  -  adequate coverage of postoperative tumour bed not technically possible

Relevance to patient case: not relevant