araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Quality of Life in Postmenopausal Women Who Are Receiving Either Exemestane or Anastrozole With or Without Celecoxib for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

Summary: RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone therapy for breast cancer may help to determine the effects of treatment on these patients and may improve the quality of life for future breast cancer patients.
  PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II, or stage IIIA primary breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Compare treatment-related symptoms using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire in postmenopausal women with receptor-positive stage I, II, or IIIA primary breast cancer undergoing treatment with exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27.
  Secondary
  -  Compare health-related quality of life using the FACT-ES questionnaire in patients treated with these regimens.
  -  Determine the extent to which differences in treatment-emergent symptoms affect overall quality of life in patients treated with these regimens.
  OUTLINE: This is a multicenter, companion study. Patients receive treatment on CAN-NCIC-MA27.
  Health-related quality of life and treatment-related symptoms are assessed using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire at baseline and at 3, 6, 12, and 24 months.
  PROJECTED ACCRUAL: A total of 1,253 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed invasive breast cancer
  -  pT1-3; pNX, pN0-2 or pN3*; M0 NOTE: *Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes
  -  Registered on protocol CAN-NCIC-MA27 within the past week
  -  Hormone receptor status:
  -  Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content ≥ 10 fmol/mg protein
  -  At least 1 tumor must be receptor-positive in patients with bilateral breast cancer
  PATIENT CHARACTERISTICS:
  Age
  -  Postmenopausal
  Performance status
  -  ECOG 0-2
  Sex
  -  Female
  Menopausal status
  -  Postmenopausal
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Able to read, understand, and complete quality of life questionnaires
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane

Summary: This study is a Phase IV, prospective, nonrandomized, community-based study of clinical outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.


Eligibility: Inclusion Criteria:
  -  Signed informed consent
  -  Available tissue for central laboratory evaluation of HER2 status
  -  Histologically confirmed, measurable or nonmeasurable but evaluable, HER2 positive metastatic breast cancer (HER2 positive is defined as 3+ staining by IHC or gene amplification by FISH, determined by the local or central laboratory)
  -  Life expectancy >6 months
  -  Female, age >=18 years
  -  ECOG performance status of 0, 1, or 2
  -  Adequate bone marrow function as indicated by the following: *ANC >1500/uL, *Platelet count >=100,000/uL
  -  Adequate renal function, as indicated by creatinine <=1.5× upper limit of normal (ULN)
  -  Adequate liver function, as indicated by bilirubin <=1.5× ULN and AST or ALT <2× ULN unless related to primary disease
  -  Use of an adequate means of birth control (women of childbearing potential)
  Exclusion Criteria:
  -  Initiation of Herceptin >=4 weeks after beginning taxane chemotherapy
  -  Prior chemotherapy for metastatic disease
  -  Prior cumulative anthracycline dose of >360 mg/m2
  -  History of significant cardiac disease or uncontrolled arrhythmias
  -  Ejection fraction of <50% or below the lower limit of normal
  -  Active infection
  -  Symptomatic or untreated brain metastases
  -  Pregnancy or lactation
  -  Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  -  Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
  -  Hypersensitivity to study medications
  -  Major organ failure or systemic disease precluding the safe administration of study medications

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Study of Patients With HER2-Positive Metastatic Breast Cancer

Summary: This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.


Eligibility: Inclusion Criteria:
  -  Signed Informed Consent document (unless the IRB has granted a waiver of consent)
  -  Signed Authorization for the Use and Disclosure of Health Information document
  -  HER2-positive breast cancer
  -  Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment
  -  Availability of cancer-specific historical data points in the patient's medical records
  Exclusion Criteria:
  -  There are no exclusion criteria for participation in this trial

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)

Summary: The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.

Detailed description: Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are superior for prevention of cardiovascular events, previous data are not enough for the patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it has not been clarified whether the evidence in Western countries could be unqualifiedly applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients with hypertension in terms of the morbidity and mortality.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of hypertension
  -  Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH)
  Exclusion Criteria:
  -  Patients who have already been administered ARB
  -  Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG)
  -  Severe/malignant/secondary hypertensive patients
  -  Pregnant women and women of childbearing potential
  -  History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months
  -  Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block
  -  Severe renal impairment (Serum creatinine >3.0 mg/dl)
  -  Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

Summary: To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy.
  The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.


Eligibility: Inclusion Criteria:
  1. The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
  2. Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
  3. Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
  Exclusion Criteria:
  1. Tumour greater than 5 cm in greatest diameter on pathological examination.
  2. The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
  3. Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
  4. Bilateral malignancy of the breast (synchronous or metachronous).
  5. More than one primary invasive tumour in the same breast.
  6. Previous surgery for breast cancer.
  7. Pathological status of axilla is unknown.
  8. Status for adjuvant systemic therapy not determined.
  9. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
  10. For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
  11. Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
  12. Currently pregnant or lactating.
  13. Breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
  14. Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \fIin situ\fR of the cervix which have been effectively treated.
  15. Geographic inaccessibility for follow-up.
  16. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

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: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

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: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving 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 or recently postmenopausal
  -  Recent surgery for breast cancer
  -  Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
  -  No prior treatment with letrozole
  Other protocol-defined inclusion criteria may apply.
  Exclusion Criteria:
  -  Metastatic disease
  -  Invasive bilateral disease
  -  Clinical or radiological evidence of existing fracture in spine or hip
  -  Prior treatment with IV bisphosphonates in the past 12 months
  -  Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
  -  Use of Tibolone within 6 months
  -  Prior use of parathyroid hormone for more than 1 week
  -  Previous or concomitant malignancy
  -  Abnormal renal function
  -  History of disease effecting bone metabolism
  Other protocol-defined exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: PTEN and IGFBP-3 Correlation in Ovarian Carcinoma Invasion

Summary: We have identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene in ovarian endometrioid carcinoma, and showed association with lower cancer migration, invasion and metastasis. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

Detailed description: We have successfully established an ovarian cancer cell line (OVTW-59), which was derived from an ovarian endometrioid carcinoma (EC), and have also established an ovarian EC invasion model. By using cDNA microarray and quantitative reverse-transcriptase polymerase chain reaction, we identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene, which were associated with lower cancer migration, invasion and metastasis. Clinically, lower IGFBP-3 was found associated with significantly higher tumor grade, advanced stage and poor survival in patients with EC tumors. Furthermore, we have proved IGFBP-3 expression correlated with lower Erk activation, but with no effect on the activation of Akt. All these two signal transduction proteins have crucial roles in cancer invasion. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

Eligibility: Inclusion Criteria:
  Clinical diagnosis of ovarian endometrioid carcinoma
  Exclusion Criteria:
  other types of ovarian epithelial carcinoma

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

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: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

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