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

Clinical trial: ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases.
  PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.

Detailed description: OBJECTIVES:
  -  Determine the inhibitory effect of ICI 182780 on the development of metastasis, as measured by disease-free survival and overall survival, in women with operable stage I or II primary breast cancer.
  -  Determine toxicity of this regimen in these patients.
  OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal).
  Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1. Patients undergo surgery between days 8 and 29.
  Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed stage I or II primary operable breast cancer
  -  Surgery planned within next 1-4 weeks
  -  Hormone receptor status:
  -  Estrogen receptor positive or unknown
  -  No known estrogen receptor negative tumor
  -  Unknown progesterone receptor status eligible
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Sex:
  -  Female
  Menopausal status:
  -  Premenopausal or postmenopausal
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  No bleeding diathesis not compatible with an IM depot injection
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use effective non-hormonal contraception during and for 2-3 months after study
  -  No other prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or cancer of the uterine cervix
  -  No psychological, familial, sociological, or geographical condition that would preclude study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  At least 2 months since prior ICI 182780
  Radiotherapy:
  -  No prior radiotherapy to primary tumor
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other concurrent preoperative therapy for breast cancer

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

Clinical trial: Cryosurgery in Treating Women With Breast Lesions

Summary: RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions.
  PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions.

Detailed description: OBJECTIVES:
  -  Determine the feasibility of temperature-monitored, ultrasound-guided cryosurgery in women with highly suspicious breast lesions.
  -  Determine the safety of this procedure in these patients.
  OUTLINE: This is a multicenter study.
  Patients undergo cryoablation of up to two breast lesions. Within 3-21 days, patients undergo lumpectomy or mastectomy.
  Patients are followed at 1, 4, 8, and 12 weeks after lumpectomy or mastectomy.
  PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Highly suspicious breast lesion on prior mammogram and/or ultrasound with confirmation of malignancy on ultrasound-guided core biopsy
  -  Tumor no greater than 2.0 cm in diameter
  -  Eligible for lumpectomy or mastectomy
  -  No superficial breast lesions
  -  No prior open surgical biopsy
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Sex:
  -  Female
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No other illness that would preclude study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  See Disease Characteristics
  -  No other surgery that would preclude study participation
  Other:
  -  No other medical treatment that would preclude study participation

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

Clinical trial: Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
  PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.


Eligibility: Inclusion Criteria:
  -  Confirmed infiltrating adenocarcinoma of the breast
  -  Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
  -  No prior radiation to the involved breast
  -  ECOG (Electrocochleography) performance status 0-2
  -  Age 18 years to 80 years
  -  Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl
  -  All liver function tests < upper limit of normal
  -  Serum creatinine < 2.0 mg/dl
  -  Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated Acquisition) scan or echocardiogram
  -  HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test. [FISH (+) is HER-2/neu (+)]
  -  If female of childbearing potential, pregnancy test is negative
  -  If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study
  -  Informed consent has been obtained
  Exclusion Criteria:
  -  Non-confirmed infiltrating adenocarcinoma breast cancer
  -  Evidence of metastasis
  -  Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin
  -  Prior radiation to the involved breast
  -  Recent breast cancer drug therapy within last 5 years of any form
  -  History of allergy to polysorbate or castor oil
  -  Ongoing active infection
  -  Concurrent life-limiting disease with a life expectancy of less than one year
  -  Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix
  -  Pregnancy, nursing, fertile women who do not use birth control device
  -  Inability to give informed consent
  -  Patients with pre-existing peripheral neuropathy > grade 2

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

Clinical trial: Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Summary: This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  -  Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
  -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
  -  Adequate renal, hepatic and cardiac function
  Exclusion criteria:
  -  Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
  -  Patients with active brain metastases
  -  Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.

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 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: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

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: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

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: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Summary: The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Detailed description: Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10).
  After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy).
  Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total).
  After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram.
  At the time of surgery, re-assessment of the tumor will be done.
  Blood work will be performed on day one of each chemotherapy cycle.

Eligibility: Inclusion Criteria:
  -  Patients must have Stage II or III histologically diagnosed breast cancer
  -  Primary invasive breast cancers that overexpress the HER2/neu oncogene
  -  Age older than 18 years
  -  Eastern Cooperative Oncology Group (ECOG) performance status of < 1
  -  White blood cell (WBC) > 4000/mm3
  -  Platelet count > 100,000/mm3
  -  Bilirubin < 1 x upper limit of normal (ULN)
  -  SGOT < 1 x ULN
  -  Creatinine < 1.5mg/dl
  -  Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy
  Exclusion Criteria:
  -  Excisional biopsy, sentinel node dissection or axillary node dissection.
  -  Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
  -  Pregnant or breast-feeding women
  -  Uncontrolled infection
  -  Active or severe cardiovascular or pulmonary disease
  -  Peripheral neuropathy of any etiology that exceeds grade 1
  -  Prior history of malignancy treated without curative intent
  -  Uncontrolled diabetes

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

Clinical trial: An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu

Summary: The purpose of this study is to observe clinical outcomes of metastatic breast cancer patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab (Herceptin)either alone or combination with chemotherapy or hormonal therapy.

Detailed description: In clinical practice, patients with metastatic breast cancer are being treated either with trastuzumab alone or trastuzumab in combination with chemotherapy or hormonal therapy as it has shown to increase survival. There is currently minimal information as to how long trastuzumab should be given after disease progresses on trastuzumab. This study is a chart review of the above-mentioned population which will capture information such as;
  -  what chemo or hormonal therapies are chosen by clinicians for Her-2 positive metastatic patients to combine with trastuzumab
  -  what the number of treatment regimens are (chemo or hormonal) given with trastuzumab
  -  what the clinical outcome of patients treated is
  -  what happens to the patients cardiac status with long term administration of trastuzumab
  -  what treatment patterns exist in the management of central nervous system metastases
  This study aims to generate a hypotheses that can be tested from the information collected after is has been analyzed to give clinicians further meaningful data to guide treatment decisions beyond treatment progression.

Eligibility: Inclusion Criteria:
  -  patients must have metastatic breast cancer
  -  tumor must have been determined to be Her-2 positive 3+ by immunohistochemistry or gene-amplified by fluorescence-in-situ hybridization (FISH)
  -  must have received trastuzumab alone or in combination with chemotherapy or hormonal therapy
  -  must not have received trastuzumab in the adjuvant or neoadjuvant setting
  -  must have started trastuzumab treatment for metastatic disease any time between January 1996 to June 2003
  Exclusion Criteria:
  -  patients who received trastuzumab prior to 1996

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

Clinical trial: California WISEWOMAN Project

Summary: The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.


Eligibility: Inclusion Criteria:
  -  National Breast and Cervical Cancer Early Detection Program (NBCCEDP)

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

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