araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

Summary: This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.


Eligibility: Inclusion Criteria:
  -  female patients, >=18 years of age, with locally advanced breast cancer.
  Exclusion Criteria:
  -  previous therapy for any invasive malignancy.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Effect of Physical Therapy on Breast Cancer Related Lymphedema

Summary: The objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.

Detailed description: Physical therapy treatment of patients with lymphoedema includes treatment based on the principles of 'Complete Decongestive Therapy' (CDT). CDT consists of following components; skin care, manual lymphatic drainage, bandaging and exercises. Regarding what type of treatment of treatments is most effective, the scientific evidence is sparse. Studies have focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not consistent.
  A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment groups: A: Complete Decongestive TherapyA (incl. manual drainage) or B: Complete Decongestive TherapyB (except manual lymphatic drainage

Eligibility: Inclusion Criteria:
  -  The diagnose breast cancer regardless of date for operation and identified lymphoedema
  -  Precede ultrasonic scanning of axilla in order to exclude local relapse
  -  Lymphoedema > 2 cm i.e. stage II-III
  -  Completed radiotherapy and/or chemotherapy at least 2 months prior inclusion
  Exclusion Criteria:
  -  Relapse of breast cancer
  -  Untreated infection
  -  Untreated heart failure
  -  Untreated renal failure
  -  Untreated deep venous thrombosis in the arm
  -  Unable to participate in physiotherapy treatment and/or not able to understand instructions

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Genomic Signatures to Predict Treatment Response

Summary: A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively evaluate the microarray-based, genomic test as a predictor of axillary lymph node response. Also, to determine whether the probability of achieving negative axillary nodes, is sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to support omitting axillary dissection.


Eligibility: Inclusion Criteria:
  -  Clinical status of lymph nodes must be available
  -  Sonographical status of lymph nodes must be available
  -  Patients must consent to documentation of cancer treatment
  -  Histologic diagnosis of invasive breast cancer, clinical stage T1-4, M0 (non-inflammatory T4c)
  -  Patients scheduled for neoadjuvant chemotherapy
  -  Treatment with a 3-weekly FEC or AC regimen (3-4 cycles) followed by 3-4 cycles of q3 weekly docetaxel or paclitaxel.
  -  Local HER2 status of tumor biopsy must be negative.
  Exclusion Criteria:
  -  The patient has a prior history of invasive or metastatic breast cancer.
  -  The patient had prior excisional biopsy of the primary invasive breast cancer.
  -  The patient had prior ipsilateral sentinel axillary lymph node biopsy for breast cancer.
  -  The patient cannot safely or feasibly undergo biopsy of the primary tumor.
  -  The patient has a diagnosis of Stage IV (distant metastatic) breast cancer.
  -  The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

Summary: The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed breast adenocarcinoma.
  -  Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
  -  Prior first-line systemic therapy in the metastatic setting.
  -  Demonstrated progression of disease by radiological or clinical assessment.
  -  Female patient, aged ≥18 years old.
  -  Estimated life expectancy >3 months.
  -  Normal Left ventricular function
  -  Adequate haematological, hepatic and renal functions.
  -  For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
  -  Ability to swallow oral capsules or tablets.
  Exclusion Criteria:
  -  More than two lines of chemotherapy with or without targeted therapy in the metastatic setting.
  -  Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product.
  -  Active central nervous system metastases, cerebral oedema, and/or progressive growth.
  -  Patients with impaired cardiac function.
  -  Uncontrolled arterial hypertension
  -  Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
  -  Serum potassium level below Lower Limit of Normal
  -  Uncontrolled hypothyroidism.
  -  Pregnant or breastfeeding women.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Breast Cancer Tumor Heterogeneity

Summary: Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.


Eligibility: Inclusion Criteria:
  1. Women > age 18 with capacity to consent
  2. Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
  3. IHC biomarkers performed on original CNB (including HER2)
  4. Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
  5. Multifocal or multicentric tumors
  Exclusion Criteria:
  1. Men
  2. Women with HER2 positive tumors detected on CNB specimens
  3. Women receiving neoadjuvant chemotherapy
  4. Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
  5. Women whose IHC marker results were inconclusive on CNB or not performed -

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: One Step Nucleic Acid Amplification in Endobronchial Ultrasound-guided Needle Aspiration Samples

Summary: The aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect lymph node metastases in lung cancer patients using EBUS-TBNA samples.

Detailed description: Regional lymph nodes are assessed before tumor resection and before initiation of chemo- or radiotherapy. Endobronchial ultrasound-guided needle aspiration (EBUS-TBNA) is a well-established method for mediastinal and hilar lymph node staging [2, 3]. Samples obtained via this route are much smaller than surgical lymph node biopsies, yet they are able to provide complete and thorough evaluation, this includes current molecular testing.
  One Step Nucleic Acid Amplification (OSNA), a molecular test that utilizes CK 19 mRNA-concentration as a target marker is becoming a rapidly dynamic method in quick detection of sentinel lymph node (SLN) metastases in breast cancer, colon cancer and other cancers.
  In lung cancer, the role of SLN is not well established. However, recent publications suggest an accurate and rapid detection of lymph node metastases in NSCLC. However this requires complete lymph node dissection either with mediastinoscopy or by other surgical means such as thoracotomy.
  The aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect lymph node metastases in lung cancer patients using EBUS-TBNA samples.

Eligibility: Inclusion Criteria:
  -  CT-scan suspicious for lung cancer,
  -  enlarged mediastinal lymph nodes (>10 mm),
  -  EBUS-TBNA to be performed,
  -  age: 18-99 years
  Exclusion Criteria:
  -  age: <18 years

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

Summary: The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility: Inclusion Criteria:
  -  Patient had a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative was included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).
  -  Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation
  -  Patient had received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  -  Patient had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
  -  Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  Exclusion Criteria:
  -  Patients had received prior treatment with LEE011.
  -  Patient had clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
  -  Patients had primary CNS tumor or CNS tumor involvement
  -  Patient had received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Non Invasive Detection of Lung and Breast Cancer by Odor Signature

Summary: The investigators have developed an early detection solution for lung and breast cancer. A system which can distinguish between different medical odors based on biosensors. Our product is user-friendly noninvasive, nonradioactive and nontoxic to the patients. The technology enables a high level of sensitivity and provides users with a quick lab response and a simple yes or no answer.
  The aim of this study is to contribute and detect the patient at the earliest possible stage, in a noninvasive, nonradioactive and nontoxic way. Exhaled breath and urine samples are a promising approach towards future possible lung and breast cancer screening method.

Detailed description: Early detection of cancer can dramatically improve the survival chances. to date, there is no efficient diagnostic tool for detection of lung cancer in early stages. Regarding breast cancer, the common screening tool us mammography, which suffer from low sensitivity and high false positive. Thus, there is an urgent need for developing a screening tool for early stages lung and breast cancer.
  The sense of smell depends on the ability of specialized sensory cells of the nose to perceive volatile compounds (VOCs). Diseases such as infections and malignancies can be associated with changes in host metabolism, accompanied by production of different VOCs, and thus a different odor. Several studies have shown that different cancers secrete different VOCs, thus produce different smell.
  We have developed a system which uses biosensors that can scent the VOCs that lung and breast cancer cell produce, thus distinguish between healthy control and lung or breast cancer. These biosensors can detect low stages lung and breast cancer.
  Patients will supply urine samples and exhaled breath samples using a kit that we will supply. The samples will be shipped to our lab, where they will be processed and the VOCs will be separated from the head space of the samples. The biosensors will be exposed to the VOCs samples and will report whether the specific sample id cancerous (lung or breast) or not.
  The Data will be collected from all samples and statistical analysis will be calculated, in order to test the specificity and sensitivity of our biosensors to detect cancerous samples.

Eligibility: Inclusion Criteria:
  -  Diagnosed Lung Cancer patients
  -  Diagnosed Breast Cancer patients
  Exclusion Criteria:
  -  Cancer patients who were treated using chemotherapy
  -  Cancer patients who were treated using radiation
  -  Cancer patients who were treated using biological treatments
  -  Cancer patients who were treated with chemotherapy
  -  Cancer patients who were treated with any anti- cancer therapies
  -  Cancer patients who use drugs that affect the immune system

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer

Summary: The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.

Detailed description: In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.

Eligibility: Inclusion Criteria:
  1. Women aged ≥18years and ≤70 years
  2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-2M0
  3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0
  4. No prior systemic or loco-regional treatment of breast cancer
  5. ECOG 0-2
  6. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit （UNL）, creatinine≤1.5 UNL, bilirubin≤1.5UNL
  7. No obvious main organs dysfunction
  Exclusion Criteria:
  1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
  2. Patient is pregnant or breast feeding
  3. Inflammatory breast cancer and metastatic breast cancer
  4. Any evidence of sense or motor nerve disorders
  5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
  6. Any concurrent malignancy other than breast cancer
  7. Know severe hypersensitivity to any drugs in this study

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

Summary: The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
  In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate.
  Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.

Detailed description: In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy.
  Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.

Eligibility: Inclusion Criteria:
  1. Women aged ≥18years and ≤70 years;
  2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0;
  3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as >1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals >2.0 or HER2 gene copy >6.0.
  4. No prior systemic or loco-regional treatment of breast cancer;
  5. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
  6. No obvious main organs dysfunction.
  Exclusion Criteria:
  1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
  2. Patient is pregnant or breast feeding;
  3. Inflammatory breast cancer and metastatic breast cancer;
  4. Any evidence of sense or motor nerve disorders;
  5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
  6. Any concurrent malignancy other than breast cancer;
  7. Know severe hypersensitivity to any drugs in this study.

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry

Summary: PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

Detailed description: This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.

Eligibility: Inclusion criteria include:
  Triple Negative Breast Cancer
  -  ER/PR <10% and HER negative per current ASCO/CAP guidelines
  -  Stages I-IV
  -  Any age at diagnosis
  -  Patient must be within 5 years of diagnosis
  -  Eligible regardless of genetic testing status
  -  Genetic testing recommended for patients meeting NCCN and Medicare guidelines
  AND/OR
  Germline mutation Carriers
  -  Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer
  -  Healthy patients harboring mutations also eligible
  -  There is no time limit from the time of diagnosis of cancer and enrollment.
  -  Eligible regardless of personal history of cancer
  Exclusion Criteria include:
  Triple Negative Breast Cancer -Patient is not within five years of diagnosis
  Germline mutation Carriers:
  -Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"

Relevance to patient case: not relevant
Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Summary: Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.
  Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.
  Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility: Inclusion Criteria:
  -  Age > 19
  -  Written informed consent
  -  ECOG 0-2,
  -  Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
  -  Adequate organ function
  Exclusion Criteria:
  -  Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
  -  Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
  -  Prolonged QT interval in ECG (QTc >450 msec)
  -  Pregnant, lactating women
  -  Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Relevance to patient case: not relevant