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

Clinical trial: Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

Summary: More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options.
  The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.


Eligibility: Inclusion Criteria:
  -  New diagnosis of breast cancer (Stages 0-III)
  -  Age <=45
  -  Premenopausal (at least one menses over past year)
  -  Has a uterus and at least one ovary
  Exclusion Criteria:
  -  Prior chemotherapy

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

Clinical trial: Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

Summary: The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)


Eligibility: Inclusion Criteria:
  -  Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
  -  Histological confirmation of Breast Cancer with documented ER+ receptor status
  -  Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL
  -  Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
  -  Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits
  Exclusion Criteria:
  -  Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.
  -  More than 1 prior regimen of chemotherapy for breast cancer
  -  ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
  -  History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
  -  Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks

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

Clinical trial: Endoscopic Breast Surgery in Treating Patients With Breast Cancer

Summary: RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.

Detailed description: PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.

Eligibility: Inclusion Criteria:
  -  Breast cancer or prophylactic mastectomy requiring axillary nodal staging
  -  Breast disease (e.g., fibroadenoma, ADH)
  -  Ability to read and/or comprehend consent form and questionnaires
  -  Ability to follow-up per protocol
  -  Not pregnant or breastfeeding
  Exclusion Criteria:
  -  Pregnant or breastfeeding
  -  Evidence of chest wall or skin* involvement
  -  NOTE: *may be endoscopy-assisted

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

Clinical trial: Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

Summary: To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

Detailed description: 1. Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
  2. All the patients enrolled will be given standard HDC and cellular therapy.HDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed by two cycles HDC, plus low-dose Oral Cyclophosphamide.
  3. PET-CT scans were done on each patients at baseline and after chemotherapy. The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
  4. Estimate time to progression, survival rates and clinical benefit response on patients.
  5. Find biomarkers associated with drug response.

Eligibility: Inclusion Criteria:
  -  Failure to anthracycline and/or taxol chemotherapy;
  -  metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
  -  Metastatic tumor can not be removed through surgery procedure;
  -  Metastatic tumor measured by PET-CT scan is at least 1cm;
  -  An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  -  Normal cardiac, hepatic, renal and bone marrow functions;
  -  Life expectancy ≥3 months.
  Exclusion Criteria:
  -  Do not finish twice PET-CT scan;
  -  Central nervous system metastases;
  -  Serious or uncontrolled concurrent medical illness;
  -  History of other malignancies;
  -  Having been enrolled in some other clinal trials within a month;

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

Clinical trial: Breast Cancer Registry - National University Health System, Singapore

Summary: The Breast Cancer Registry aims to collect clinical data of all breast cancer patients diagnosed and/or treated in the National University Hospital, with the goal of understanding risk factors, presenting symptoms, diagnosis, treatment, and outcome data of breast cancer in Singapore. This information will contribute to improving management of breast cancer patients.


Eligibility: Inclusion Criteria:
  - All breast cancer patients who were diagnosed or managed in NUH.
  Exclusion Criteria:
  - Non breast cancer 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: Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

Summary: This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.


Eligibility: Inclusion Criteria:
  -  Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
  -  Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
  -  Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
  -  Subject with presence of measurable disease based on RECIST 1.1
  -  Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer
  Exclusion Criteria:
  -  Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
  -  Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
  -  Subject with current active malignancy other than breast cancer
  -  Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
  -  Subject with significant renal or hepatic dysfunction
  -  Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
  -  Subject with insufficient bone marrow function
  -  Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
  -  Subject with current active bacterial, Hepatitis B or C, and/or HIV infections

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

Clinical trial: Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion

Summary: The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.

Detailed description: 1. The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
  2. Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
  3. The enriched cancer cells are flash frozen and stored at -80℃ until processing.
  4. The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
  5. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility: Inclusion Criteria:
  -  Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion
  -  an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  -  At least one measurable lesion;
  -  Normal cardiac, hepatic, renal and bone marrow functions;
  -  Life expectancy ≥3 months;
  -  Discontinuity of previous chemotherapy for a minimum of 4 weeks.
  -  Not receive chemotherapy in pleural cavity
  Exclusion Criteria:
  -  previous history of other malignancies;
  -  previous surgery history on the needle biopsy organ;
  -  Serious or uncontrolled concurrent medical illness.

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

Clinical trial: Midostaurin (PKC412) for Locally Advanced Rectal Cancer

Summary: This study combines midostaurin (PKC412) with radiation and a standard chemotherapy drug call 5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type of kinase inhibitor which works by blocking proteins associated with cancer cell growth. Previous studies also suggest that midostaurin may help increase the effectiveness of radiation therapy. In this research we are looking for the highest dose of midostaurin that can be given safely in combination with standard chemoradiation.

Detailed description: Midostaurin capsules will be taken by mouth for 8 weeks. For the first 2 weeks midostaurin will be taken alone (no chemoradiation). After 2 weeks standard chemoradiation will be added to the midostaurin regimen. Subjects receive midostaurin and chemoradiation for an additional 6 weeks. Physical exams will be done weekly. Blood samples will be taken and an optional tumor biopsy will be performed in week 2.
  4-5 weeks after completing chemoradiation and midostaurin subjects will undergo surgery as standard of care. Tumor tissue from the surgery will be used for research purposes. A Ct scan of chest, abdomen, and pelvis will be performed.
  After completion of surgery, subjects will have an end of study visit with physical exam, blood tests. CT scans of chest, abdomen, and pelvis will be performed yearly for 5 years.

Eligibility: Inclusion Criteria:
  -  Adenocarcinoma of the rectum
  -  T3/4 or N+ disease
  -  Life expectancy > 3 months
  -  Normal organ and marrow function
  Exclusion Criteria:
  -  Metastatic disease
  -  Pregnant or breastfeeding
  -  Prior radiotherapy
  -  Receiving other investigational agents
  -  History of inflammatory bowel disease
  -  Active scleroderma or CREST syndrome
  -  Uncontrolled intercurrent illness
  -  History of a different malignancy unless disease free for at least 5 years
  -  HIV or active viral hepatitis
  -  Impaired cardiac function

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

Clinical trial: Breast Cancer Prevention Education

Summary: We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are:
  1. To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research.
  2. To evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.


Eligibility: Inclusion Criteria:
  -  African American women
  -  Ages 35-70
  -  No personal history of cancer
  -  Resident of Philadelphia metropolitan area
  Exclusion Criteria:
  -  Non-African American
  -  Male
  -  Under 35 or over 70 years of age
  -  Personal history of cancer
  -  Not a resident of Philadelphia Metropolitan Area

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

Clinical trial: Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

Summary: This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.


Eligibility: Inclusion Criteria:
  -  BMI at least 25.0 kg/m2
  -  Diagnosed with Stage I, II, or III breast cancer within past 5 years
  -  Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
  -  Not scheduled for or currently undergoing chemotherapy
  -  Accessible geographically and by telephone
  -  Able to communicate dietary and physical activity data via telephone
  -  If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
  -  Post-menopausal at diagnosis
  Exclusion Criteria:
  -  Preliminary bloodwork outside of specified ranges
  -  Evidence of renal insufficiency, liver disease, or congestive heart failure
  -  Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
  -  Recent initiation (< 3 months ago) of thiazides or β-blockers
  -  Taking insulin or other antidiabetic drug
  -  Other primary or recurrent invasive cancer in past 10 years
  -  Unable to commit to study requirements

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

Clinical trial: Getting Back on Track: An Educational Group for Women With Breast Cancer

Summary: As the number of women who survive breast cancer continues to grow, more attention is being paid to their quality of life and the disease's long-term effects. The transition from patient to survivor, also termed the "re-entry transition", can be a very difficult and stressful time. A brief psychosocial intervention delivered at this important transition time may address the challenges that women face at re-entry, facilitating greater adaptation and more optimal recovery. The purpose of the proposed RCT is to test the acceptability and effectiveness of a single-session group psychoeducational intervention led by a multi-disciplinary team on adjustment to survivorship. A randomized controlled trial design (RCT) will be used to recruit 440 women attending the breast clinic at Princess Margaret Hospital in Toronto. Participants will be recruited while completing their adjuvant radiotherapy and those who agree to participate will complete the baseline questionnaire package (T0). They then will be randomized to receive either: (1) standard print material (CRL group n=220); or (2) standard print material and a single session group psychoeducational intervention (INT group n=220). Two weeks following randomization, participants in the CRL group will be given the "Getting Back on Track: Life after Treatment" booklet (current standard care), which includes information on the new health care team, physical side-effects, diet and exercise, emotional and social needs and returning to everyday life. Participants in the INT group will receive the same booklet and will also attend a 2- hour psychoeducational group session facilitated by a multidisciplinary team. Participants in both groups will be asked to complete the questionnaire package again at 3 months (post-1) and 6 -months (post-2) following the completion of cancer treatment. Participants in the INV group will also be asked to rate their satisfaction with the class and provide feedback on the content. The proposed intervention will be one of the few clinical interventions designed to address the service gap in helping women to make the transition from patients to survivors by using a single-session psychoeducational group intervention.


Eligibility: Inclusion Criteria:
  -  outpatients attending treatments at PMH
  -  have a diagnosis of breast cancer;
  -  have undergone initial treatment for breast cancer;
  -  are receiving adjuvant radiation therapy as last hospital-based component of treatment;
  -  are able to speak, read and write English.
  Exclusion Criteria:
  -  metastatic disease
  -  local recurrence
  -  cognitive impairment
  -  if they are an inpatient

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

Clinical trial: Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer

Summary: If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in increased ER expression in ER-negative/low primary breast tumors.


Eligibility: Inclusion Criteria:
  -  Female breast cancer patient > 18 years.
  -  Patients must have biopsy-proven clinical Stage Ic-III invasive breast carcinoma with ≤ 10% ER expression by immunohistochemistry (IHC) analysis.
  -  Patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (ER, protein/gene expression analysis).
  -  Patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. Planned procedure may include lumpectomy or mastectomy as clinically indicated.
  -  Patients must have an ECOG Performance Status of 0 - 1.
  -  Patients must have the ability to understand and willingness to sign an English or a Spanish language written informed consent document.
  Exclusion Criteria:
  -  Male breast cancer patient.
  -  Patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. Patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.
  -  Patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.
  -  Patients should not have known or strongly suspected BRCA mutation by history (genetic testing not required).
  -  Patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. Patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.

Relevance to patient case: not relevant