araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

Summary: This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.

Detailed description: In a clinical context, there is a lack of molecular compounds with demonstrated clinical activity in delaying/reversing resistance to endocrine agents. CDK 4/6 inhibitors may represent a biologically-driven option in this context.
  With the present study investigators aim to complement the ongoing trial on PD0332991 by acquiring information on its clinical activity in post-menopausal patients with ER positive, Her2 negative advanced breast cancer patients already pretreated with a first-line or second line endocrine therapy.

Eligibility: Inclusion Criteria:
  -  Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease
  -  ER positive tumor ≥ 10%
  -  HER2 negative breast cancer by FISH or IHC
  -  Progression of advanced breast cancer on first or second line endocrine therapy for advanced breast cancer
  -  Paraffin-embedded tumor available for centralized assessment of biomarkers
  -  Measurable disease according to RECIST 1.1 (bone only disease is allowed only if measurable).
  -  Postmenopausal status
  -  Eastern Cooperative Oncology Group (ECOG) Performance status 0 -2
  -  Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade >1
  -  Adequate organ function
  Exclusion Criteria:
  -  Unstable brain metastases
  -  Prior treatment with more than one line of CT or more than two lines of HT advanced breast cancer or any CDK inhibitor
  -  Current treatment with therapeutic doses of anticoagulant
  -  Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors / inducers, drugs that are predominantly metabolized by CYP3A with narrow therapeutic indices, drugs with the potential of prolonging QT interval
  -  Diagnosis of any secondary malignancy within the last 3 years
  -  Active inflammatory bowel disease or chronic diarrhea
  -  Known human immunodeficiency virus infection; active hepatitis C, active hepatitis B

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

Summary: The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.
  The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.
  On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.


Eligibility: Inclusion Criteria:
  -  Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
  -  Menopausal women with age > 55 years
  -  Tumor size <= 15 mm by ultrasonography
  -  Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis & Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
  -  Good lesion boundary with ultrasonography and MRI
  -  Minimal distance of 5 mm between the skin and the tumor
  -  Performance Status 0-1
  -  Ability to understand and willingness to sign a written informed consent document
  -  Covered by a medical insurance
  -  Signed informed consent
  Exclusion Criteria:
  -  Invasive lobular carcinoma
  -  Tumor with retro-nipple location
  -  Extended microcalcifications (> 15 mm) with mammography
  -  Xylocaine allergy
  -  Patient deprived of freedom

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples

Summary: A multi-center non-interventional, in-vitro trial for evaluation of concordance of the results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the Immunohistochemical (IHC) method in pathological samples collected from participants with breast cancer.

Detailed description: For accurate selection of participants who will be treated with anti-HER2, primary crucial thing to do is the right identification of HER2 in breast tumor cells. The advantages and disadvantages of IHC and In-Situ Hybridization (ISH) for the detection of HER2 status is still disputable. It is generally agreed on that HER2 study should be applied on all invasive breast cancer participants. It can be used together with IHC which measures HER2 protein expression or ISH which assesses HER2 gene amplification. With regard to IHC, the inconsistency of sensitivity and specificity of marketed antibodies, differences in interpretation and technical artifacts cause problems in diagnosis on occasion. There is not enough study on reasons which cause the consistence and discrepancies between laboratories in HER2 detection with IHC method.

Eligibility: Inclusion Criteria:
  Samples that fulfill all of the criteria will be evaluated for the study.
  -  Samples of women aged greater than or equal to (>/=) 18 and less than (<) 75 years
  -  Tumor samples already diagnosed based on the IHC score of 0 to +3
  -  Samples of primary lesions excluding lymph nodes
  -  10 percent (%) neutral buffered formalin-fixed and paraffin embedded tissue samples
  Exclusion Criteria:
  Samples that fulfill any of the criteria below will not be included in the study.
  -  Non-invasive ductal carcinoma (NOS) samples
  -  Tru-cut biopsies
  -  Non-breast cancer pathological samples

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Safety and Pharmacokinetics of Atezolizumab in Combination With Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Participants With HER2-Positive Breast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

Summary: This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer.


Eligibility: Inclusion Criteria:
  -  Histologically documented HER2-positive and HER2-negative (cohort E only) breast cancer
  -  Metastatic breast cancer that is measurable (Stage 1) or early breast cancer with a primary tumor size greater than (>) 2 centimeter (cm) (Stage 2)
  -  Eastern cooperative oncology group (ECOG) performed status of 0, 1 or 2; 0 or 1 (cohort E only)
  -  Life expectancy of 12 or more weeks
  -  Adequate hematologic and end-organ function
  -  Left ventricular ejection fraction greater than or equal to (>=) 50 percentage (%); >=55% (cohort E only)
  Exclusion Criteria:
  -  Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
  -  Leptomeningeal disease
  -  Pregnancy or lactation
  -  History of autoimmune disease
  -  Prior allogeneic stem cell or solid organ transplantation
  -  Positive test for human immunodeficiency virus (HIV)
  -  Active hepatitis B or hepatitis C

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: [18F]FLT PET/CT in Rb+ Metastatic Breast Cancer

Summary: In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer [18F]fluorothymidine (FLT).

Detailed description: This protocol is designed to develop relationships between parameters determined from imaging biomarker studies and ones used for determination of therapeutic response to combined CDK4 Inhibitor and chemotherapy regimens. Imaging will occur prior to starting therapy on the separate therapeutic protocol UPCC 06115. Patients may undergo a second FLT PET/CT scan following a 3-day run of ribociclib (LEE011) (day -6 to -4) and a third FLT PET/CT scan on cycle 1 day 12 following two treatments of weekly Paclitaxel to compare changes in FLT uptake measures.

Eligibility: Inclusion Criteria:
  1. At least 18 years of age
  2. History of histologically or cytologically confirmed breast cancer, any ER, PR or HER2 status is allowed as long as it expresses the Rb protein.
  3. At least one site of metastatic breast cancer that is outside of the liver and bone that is identified by standard imaging (e.g. CT, MRI, FDG PET/CT, ultrasound, x-ray)
  4. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
  5. Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel.
  Exclusion Criteria:
  1. Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential.
  2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
  4. Ineligible for the therapeutic trial UPCC 06115

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

Summary: This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice.
  To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.

Detailed description: This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. Investigators will include all consecutive adult patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014). These patients must meet all the inclusion criteria and none of the exclusion criteria established in this protocol.
  The primary objective is to describe the effectiveness of nab-paclitaxel in terms of response in early lines of chemotherapy for metastatic breast cancer in routine clinical practice.
  This study plans to collect data retrospectively, provided they are available in the patient's medical record and according to routine clinical practice.

Eligibility: Inclusion Criteria:
  -  Women ≥18 years of age.
  -  Confirmed diagnosis of MBC (stage IV).
  -  Breast adenocarcinoma confirmed histologically.
  -  HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer.
  -  Patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in HER2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment.
  -  Ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given).
  Exclusion Criteria:
  -  Patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent.
  -  Patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity.
  -  Patients who have taken part in any clinical trial (interventional) during the study period.

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Summary: Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.


Eligibility: Inclusion Criteria:
  -  Female
  -  Age 21 or older
  -  Metastatic breast cancer (MBC) diagnosis - Stage IV
  -  Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or biologic regimens
  -  Approval from the treating clinician to engage in moderate-intensity physical activity.
  -  Patient-assessed ability to walk and engage in moderate physical activity
  -  Proficient in English.
  -  IRB approved signed written informed consent.
  -  Willing and able to do all study requirements.
  Exclusion Criteria:
  -  One or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention.
  -  No more than 3 prior chemotherapy regimens.

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation

Summary: Lymphoscintigraphy is a noninvasive，accurate and effective imaging modality. In this study, it is used to investigate the imaging characteristics of patients'upper limb lymphatic drainage before operation, and the influence of operation on it.

Detailed description: The global burden of breast cancer continues to increase largely because of the aging and growth of the world population. More than 1.38 million women worldwide were estimated to be diagnosed with breast cancer in 2008, accounting for 23% of all diagnosed cancers in women. Given that the 5-year survival rate for breast cancer is now 90%, experiencing breast cancer is ultimately about quality of life. Women treated for breast cancer are facing a life-time risk of developing lymphedema, a chronic condition that occurs in up to 40% of this population and negatively affects breast cancer survivors' quality of life. It's becoming more and more important to do more research on the breast cancer-related lymphedema. Axillary reverse mapping (ARM) is a technique used to map arm lymphatic drainage during axillary lymph node dissection (ALND) and/or sentinel lymph node dissection (SLND). It's necessary for the investigators to understand the participants' upper limb lymphatic drainage before operation and what the investigators have done on it during operation. It can be easy to understand the influence of operation on the participants' upper limb lymphatic drainage, the possibility and safety of reserving lymph nodes draining the upper extremity lymph.

Eligibility: Inclusion Criteria:
  For inclusion in the study patients must fulfil all of the following criteria:
  1. Diagnosed with breast cancer
  2. There is no metastasis except axillary nodes
  3. Agree to receive Lymphoscintigraphy of upper extremity
  Exclusion Criteria:
  Any of the following is regarded as a criterion for exclusion from the study:
  1. Pregnancy or lactation
  2. Inflammatory breast cancer
  3. Disagree to receive Lymphoscintigraphy of upper extremity
  4. History of axillary lymph node resection

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Palbociclib / Letrozole in African American Women With HR+ HER2- Breast Cancer

Summary: This study aims to evaluate the hematological safety of palbociclib with letrozole in African American women with hormone receptor positive HER2 negative advanced breast cancer. Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia

Detailed description: The study is designed to assess the rate of completion of planned oncology therapy in the absence of a hematological event defined as episodes of febrile neutropenia and treatment discontinuation due to neutropenia. A completion rate of 80% is considered of clinical relevance as to benefit breast cancer patients who are at a higher risk of having ethnic neutropenia where as a completion rate of 60% is considered poor and to justify additional safety studies. A two stage design with a total of 35 patients is used to test if the completion rate is at least 80% versus if it is below 60% with 80% power at a significance level of 5%.
  An exact confidence interval of the completion rate will be calculated. Investigators estimate there will be no more than a 10% rate of febrile neutropenia. Due to the small sample size, the analysis of secondary endpoints will be descriptive and will not include specific hypothesis testing.

Eligibility: Inclusion Criteria:
  1. Self-identified Black, African or African American women of ≥ 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
  2. ER-positive and/or PgR-positive tumor based on local laboratory results
  3. HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)
  4. Patients must be appropriate candidates for letrozole therapy
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  6. Adequate bone marrow function:
  -  Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 (1.0 x 109/L);
  -  Platelets ≥100,000/mm3 (100 x 109/L);
  -  Hemoglobin ≥9 g/dL (90 g/L).
  Exclusion Criteria:
  1. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
  2. Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.
  3. Previous CDK4/6 inhibitor

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: A Multicenter Breast Cancer Biospecimen Registry

Summary: This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.


Eligibility: Inclusion Criteria:
  1. Females of all racial and ethnic groups who are 40 years or older.
  2. Women must:
  1. have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and
  2. be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.
  Exclusion Criteria:
  1. Inability to sign informed consent.
  2. More than one radiological finding.
  3. Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
  4. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
  5. Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
  6. Received any experimental therapeutic treatment during the previous 3 months.
  7. Received any blood product transfusion within the previous 3 months.
  8. Use of illegal drugs during the previous 3 months.
  9. Pregnant or nursing at the time of enrollment or in the preceding 12 months.

Relevance to patient case: not relevant