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

Clinical trial: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

Summary: This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

Detailed description: This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

Eligibility: Inclusion Criteria:
  1. All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible.
  2. The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast.
  3. The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy.
  4. Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
  5. All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards.
  Exclusion Criteria:
  1. Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
  2. Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
  3. Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
  4. Patients with another active systemic malignancy in the past year.

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 Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Summary: Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.


Eligibility: Inclusion Criteria:
  -  Stage I-IIIa breast cancer
  -  Postmenopausal
  -  Recent surgery for breast cancer
  Exclusion Criteria:
  -  Metastatic disease
  -  Invasive bilateral disease
  -  Clinical or radiological evidence of existing fracture in spine or hip
  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 Difference in Presentation Level of Variant Receptors in Female Breast Tissue in Macromastia and Micromastia

Summary: There are more and more macromastic women in Taiwan, which may due to the high cholesterol foods. Patients with macromastia not only suffered from physical problems but also psychological discomforts.

Detailed description: Large breasts cause neck and back pain, irritating grooves, cut in the skin of the shoulders by the pressure of brassiere straps, breast pain, and maceration and dermatoses in the inframammary region. From a psychological point of view, excessively large breasts can be troublesome focus of embarrassment for the teenager as well as the woman in her senior years. Unilateral hypertrophy with asymmetry heightens embarrassment. Thus, patients seek to reduce the size of their breasts.
  In the human female, variant receptors were detected in epithelial cells in normal breast tissue, benign breast lesions, breast carcinoma tissue, and breast cancer cell lines2-11. The cause of the difference in breast development status is still unclear. Abnormalities at the tissue receptor level may be important in the pathophysiology of macromastia. This study aimed to make clear the difference in variant receptor levels between breast hypertrophy patients and macromastia ones by examining the receptor levels in breast tissue. Then, we could explore the possible etiology of mammary hypertrophy and macromastia.

Eligibility: Inclusion Criteria:
  -  patients receiving reduction mammoplasty
  Exclusion Criteria:

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

Clinical trial: Light Based Analysis of Developing Breast Tissue in Adolescent Girls: a Feasibility Study

Summary: The proposed pilot study attempts to investigate the feasibility of Optical Spectroscopy (OS) as a method to quantify breast tissue composition and density in adolescent females. Our goals include: to assess whether adolescent girls can be instructed to assist with the OS measurement procedure and to determine the OS technique's ability to show breast tissue composition and density in adolescent breast tissue.

Detailed description: The period between menarche and the age of first full-term pregnancy has been identified as being most crucial for establishing an individual's future breast cancer risk. Epidemiological studies further suggest exposures, such as foods and toxins, during adolescence to have a significant impact on the likelihood of transformation in the developing breast resulting in cancer later in life. Adolescent diet affects mammary development directly and indirectly by influencing the micronutrients and the hormonal status of the adolescent. The goal of this study is to investigate the feasibility of Optical Spectroscopy (OS), a method based on differential light scattering and absorption in tissue, to quantify bulk breast tissue properties in adolescent females.

Eligibility: Inclusion Criteria (Girls):
  -  Are in good health and are able to provide assent
  -  Are between the ages of 10 and 14
  -  Are interested in participating in this study
  -  Are willing to come, accompanied by a parent, to the Princess Margaret Hospital
  Inclusion Criteria (Parents):
  -  Are able to provide consent
  -  Are willing to accompany your daughter to the Princess Margaret Hospital for one visit of about 45 minutes
  Exclusion Criteria (Girls):
  -  Have had previous surgeries to the chest 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: 6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer

Summary: The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.


Eligibility: Inclusion Criteria:
  -  Histologically proven cancer of the breast,
  -  Mastectomy or complete tumorectomy,
  -  Histologically proven homolateral, axillary lymph node involvement (at least 1 N+)
  -  Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months,
  -  Biological criteria (before the first FEC cycle):
  -  Neutrophils >1.5 109 /L
  -  Platelets >100 109/L
  -  Hemoglobin >10 g/dl
  -  Creatininemia <120 mmol/1
  -  Bilirubinemia <1.5 Upper normal value
  -  Female patients over 18 years old
  -  Written and signed informed consent
  -  Performance Status less than or equal to 2 (WHO scale, see Annex IV)
  Exclusion Criteria:
  -  Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast,
  -  Bilateral breast cancer or history of contralateral breast cancer
  -  Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation
  -  Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
  -  Inflammatory breast cancer
  -  Distant metastasis or supraclavicular adenopathy
  -  Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years
  -  Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol
  -  Psychiatric pathology
  -  Patient participating in another trial

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 Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease

Summary: This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion administered on subsequent cycles.


Eligibility: Inclusion Criteria:
  -  Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease
  -  Tumors tested by IHC must be 3+ positive for HER2 overexpression. Tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER2. Tumors that are 3+ by IHC but negative by FISH assay are ineligible
  -  Patients must have measurable disease
  -  Patients may NOT have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer.
  -  Patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer, including taxane-based chemotherapy regimens. Patients may NOT have received trastuzumab in the adjuvant setting unless disease free interval from completion of trastuzumab to time of relapse is greater than 12 months.
  Exclusion Criteria:
  -  Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval
  -  Patients with known leptomeningeal carcinomatosis

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 Decision Aid for Women With Early Stage Breast Cancer

Summary: To enhance information transfer and decision making for women with breast cancer.

Detailed description: Our specific objectives are: (i) to develop computer and paper based versions of the Decision Boards for (a) chemotherapy for early stage breast cancer (chemotherapy versus no treatment), (b) mastectomy versus lumpectomy plus radiation and (ii) to compare the relative effectiveness of the computer and paper based versions with the standard Decision Board for patients with early breast cancer.

Eligibility: Inclusion Criteria:
  Chemotherapy Group:
  -  Female
  -  Histologically documented invasive carcinoma of the breast treated with modified radical mastectomy or lumpectomy
  -  Axillary node dissection
  -  Chemotherapy alone or in addition to tamoxifen as an appropriate treatment option
  Surgery Group:
  -  Female
  -  Newly diagnosed carcinoma of the breast diagnosed either by cytology or pathological examination, OR if no biopsy, a strong clinical suspicion of malignancy
  -  Clinical stage I or II disease
  -  Candidate for breast conserving surgery
  Exclusion Criteria:
  Chemotherapy Group:
  -  Candidate for CEF chemotherapy
  -  Clinical evidence of metastatic disease
  -  Serious comorbidity that would preclude receiving chemotherapy treatment
  -  Unable to speak or read English fluently (including visual impairment)
  -  Mentally incompetent including any psychiatric or addictive disorders that would preclude shared decision-making
  Surgery Group:
  -  Previous surgery for breast cancer
  -  Previous breast irradiation
  -  Pregnant
  -  Clinical suspicion of bilateral breast cancer
  -  Serious comorbidity that would preclude definitive surgery
  -  Unable to speak or read English fluently (including visual impairment)
  -  Mentally incompetent including any psychiatric or addictive disorder that would preclude shared decision making

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

Clinical trial: Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients

Summary: vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen

Detailed description: vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen. Antigens used are Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma patients.

Eligibility: Inclusion Criteria:
  -  stage III/IV
  -  fresh frozen tumor-tissue
  -  age 18-75
  -  informed consent given
  -  Karnofsky >= 70%
  Exclusion Criteria:
  -  systemic glucocorticoids
  -  brain metestasis
  -  other malignancies

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

Clinical trial: Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer

Summary: The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.

Detailed description: The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.
  Hormonal therapy is one of the most common treatments for breast cancer in women. Unfortunately, many women on hormonal therapy suffer from hot flashes (the sudden sensation of heat throughout the face, neck and chest, with or without shivering and sweating). Many medicines have been used to treat hot flashes, but no single medication has been found to work reliably.
  Acupuncture has been shown to be effective for many conditions in Western medicine specifically for dry mouth in people who have received radiation to their head and neck, as well as for hot flashes in women during menopause (the "change of life"). In this study, we are investigating whether acupuncture is effective for women suffering hot flashes that result from their treatment of breast cancer.

Eligibility: Inclusion Criteria:
  -  Female
  -  18 years of age or older
  -  History of breast cancer who have received hormonal therapy
  -  Personal history of hot flashes
  -  Patients will be accepted if receiving therapy with traditional allopathic medicines if their hot flashes have persisted after two months
  Exclusion Criteria:
  -  Receiving therapy with traditional allopathic medicines for hot flashes

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

Clinical trial: Quality of Life in African-American or Caucasian Female Breast Cancer Survivors

Summary: RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors.
  PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors.

Detailed description: OBJECTIVES:
  -  Compare disease-specific, generic, and global quality of life measures in African-American survivors of breast cancer with Caucasian survivors of breast cancer.
  -  Compare these quality of life measures in African-American survivors of breast cancer with control group of African-American women with no history of breast cancer.
  OUTLINE: Patients and healthy participants complete a battery of quality of life (QOL) questionnaires over approximately 65 minutes by mail or over the phone, including the Sexual Function Index, Functional Assessment of Cancer Therapy - Fatigue, Concerns About Recurrence Scale, and other measures of symptoms/side effects (including sleep problems), the RAND Physical Functioning -10 Scale, Center for Epidemiologic Studies - Depression Scale, assessment of family function/social support, ENRICH Marital Satisfaction Scale, Reed Spiritual Perspective Scale, assessments of coping and body image, Post-Traumatic Growth Inventory, and the Index of Well-being. Demographic, disease, treatment, and comorbidity information, as well as menstrual and gynecological history, work status and insurance history, and a measure of health care provider communication is collected using questionnaires and medical chart review.
  PROJECTED ACCRUAL: A total of 195 patients and healthy participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  African-American or Caucasian breast cancer survivor
  -  Diagnosed with stage I-III breast cancer between the years of 1995-2003
  -  Receiving follow up care at the Indiana University Cancer Center (IUCC), the IUCC Northside Clinic, Spring Mill Clinic, or Wishard Memorial Hospital
  -  Healthy African-American
  -  Acquaintance of an African-American breast cancer survivor
  -  Not known to have breast cancer
  PATIENT CHARACTERISTICS:
  -  Female
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Physiological Biomarkers of Cancer Treatment Related Fatigue in Women With Breast Cancer.

Summary: Physiological Biomarkers of Cancer Treatment Related Fatigue in Women with Breast Cancer.

Detailed description: As above.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed early stage breast cancer.
  Exclusion Criteria:
  -  Not specified.

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

Clinical trial: Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Summary: To examine nipple aspirate fluid for secretions that may be identified as a high risk indicator for development of breast cancer, and compare those to serum analysis.

Detailed description: To examine nipple aspirate fluid analysis in lactating women for local concentration of estrogen, prolactin, glucocorticoids, insulin, parity, prior lactation and age. NAF secretors have been reported to have modest increase in breast cancer risk compared to non-secretors . Estrogen levels have been found to be markedly higher in NAF samples than in the serum collected from the same women. Estradiol and estrone concentrations in premenopausal women are 10x and 20x greater in NAF samples than in serum and 50x and 35x greater in post-menopausal women not on HRT. It has been suggested that the disparity between serum and NAF levels may be due to local estrogen production via aromatase and sulfatase.

Eligibility: Inclusion Criteria:
  -  women with high a high risk of breast cancer
  -  Older than 18
  Exclusion Criteria:
  -  anticoagulants
  -  marked breast tenderness
  -  pregnant or within twelve months of breast feeding/childbirth

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

Clinical trial: Protocol for Women at Increased Risk of Developing Breast Cancer

Summary: To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.

Detailed description: A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.

Eligibility: Inclusion Criteria:
  -  women who have a high risk of breast cancer
  -  older than 18 years
  Exclusion Criteria:
  -  anticoagulants
  -  marked breast tenderness
  -  pregnant or within twelve months of breast feeding/childbirth

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

Clinical trial: ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.

Summary: The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.


Eligibility: Inclusion Criteria:
  -  Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.
  -  At least 6 lymph nodes examined.
  -  Good or intermediate tumour differentiation.
  -  <6 weeks before start of adjuvant therapy.
  -  Oestrogen or Progesterone positive
  Exclusion Criteria:
  -  Premenopausal.
  -  Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.
  -  In-situ/T4 carcinoma.
  -  Age >80 years.
  -  World Health Organisation performance index >3.
  -  Serious accompanying diseases

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 Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

Summary: The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced HER2+ (human epidermal growth factor 2) breast cancer.

Detailed description: Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.

Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
  -  Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
  -  Over-expression of HER2
  -  Tumor tissue available and adequate for analysis at screening
  -  At least one measurable lesion
  Exclusion Criteria:
  -  Prior treatment with Herceptin (Arm B only)
  -  More than 4 prior cytotoxic chemotherapy regimens
  -  Subjects with bone or skin as the only site of measurable disease
  -  Inadequate cardiac function
  -  Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
  -  Active central nervous system metastases
  -  Pregnant or breastfeeding women
  -  Inability to swallow the HKI-272 capsules

Relevance to patient case: not relevant