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A Study Using Bioimpedance Spectroscopy versus Tape Measurement in Catching and Intervening in the Early Onset of Lymphedema
Jacksonville, FL
The purpose of this study is to compare the use of Bioimpedance Spectroscopy versus tape measurements for follow-up arm measurements after regional treatment for breast cancer. Catching the smallest increases in fluid buildup and intervening early may result in a decrease in the rate of progressions to chronic lymphedema.
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A Study of the Bacteria Found in Cancerous and Non-cancerous Breast Tissue
Rochester, MN
The purpose of this study is to see if having different kinds of bacteria genes in breast tissue may be connected to the risk of getting breast cancer.
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Engineering Gut Microbiome to Target Breast Cancer
Jacksonville, FL
The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.
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Robotic vs. Open NSM for Early Stage Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
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Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery
Jacksonville, FL
The purpsoe of this study is to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.
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A Study to Establish a Living Breast Organoid Biobank for Translational Research
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Researchers at Mayo Clinic are developing a Biobank of adult stem cell-rich breast organoids, a new research resource to facilitate normal and cancer stem cell research. Subjects in the Biobank will provide samples of excess breast tissue, complete a health questionnaire, and allow access to medical records now and in the future. The Biobank serves as a library for researchers; instead of having to look for volunteers for each new project, researchers can use samples from the Biobank as well as share information already collected.
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Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well anastrozole and letrozole after surgery work in treating patients with stage I-III breast cancer. Drugs, such as anastrozole and letrozole may stop the growth of tumor cells by decreasing the amount of estrogen made by the body. Giving anastrozole and letrozole after surgery may prevent breast cancer from coming back (recurrence).
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Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
No Locations
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill ...
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Mayo Biopsy Marker
Rochester, MN
This is a Phase 0 clinical trial to evaluate a twinkling biopsy marker (Patent Application Title: Non-Metallic Ultrasound-Detectable Markers Patent Application No.: 62/903,078, Application Type: Provisional) for ultrasound conspicuity in patients with breast cancer and locally advanced disease involving the axillary lymph nodes.
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Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.
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Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
Rochester, MN
This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC). The Following drugs will be use in combination with Ruxolinitinib. - Paclitaxel (also called Taxol) - Doxorubicin also called Adriamycin - Cyclophosphamide, also called Cytoxan
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Breast Cancer: Can We Predict Pathological Complete Response following Neoadjuvant Treatment?
Scottsdale/Phoenix, AZ
This project will investigate whether ctDNA analysis in newly diagnosed stage I, II, III breast cancer patients treated with neoadjuvant systemic therapy can predict pathological Complete Response (pCR).
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Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
Rochester, MN
This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
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A Study to Evaluate Preoperative Oral Microbiota-Based Investigational New Drug to Target Immune Response in Patients with Operable Stage I-III Breast Cancer
Jacksonville, FL
The primary purposes of this trial are to determine the safety and tolerability of RBX7455 given for at least 2 weeks and not more than 4 weeks prior to surgery, and to evaluate intratumoral immune system resonse, including TILs, CD4, and CD8 T cells, in operable breast cancer patients.
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Breast-Conserving Surgery and Radiation Therapy in Patients with Multiple Ipsilateral Breast Cancer
Rochester, MN
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer
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Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial has several primary objectives. One primary objective is to compare the efficacy of 3 different endocrine therapies, the estrogen receptor down regulator fulvestrant and the aromatase inhibitor anastrozole, either alone or in combination, in reducing cancer growth before surgery (neoadjuvant) in postmenopausal women with clinical stage II-III estrogen receptor positive and HER2 negative breast cancer. Another primary objective is to evaluate whether patients who achieved a modified PEPI (Preoperative Endocrine Prognostic Index) score of 0, defined by tumor size <5 cm,="" n0,="">5><2.7% (by central testing), at surgery post 6 months of neoadjuvant endocrine therapy ... (by="" central="" testing),="" at="" surgery="" post="" 6="" months="" of="" neoadjuvant="" endocrine="" therapy="" ...="">2.7% (by central testing), at surgery post 6 months of neoadjuvant endocrine therapy ... >
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Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer, the ENHANCE Study
Rochester, MN
The purposes of this study are to evaluate whether pre-NAC peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer, and to evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.
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Outcomes and Patient Satisfaction for Patients Admitted to the Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Jacksonville, FL
The purpose of this study is to investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home. The secondary intent is to investigate overall patient satisfaction with the Care Hotel Model.
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A Registry for the Collection and Maintenance of Biological Specimens for Breast Cancer Research
Rochester, MN
The purpose of this registry is to collect and maintain samples of breast tissue from women and men undergoing surgery for a breast related concern at Mayo Clinic Rochester, to create a biospecimen resource for the study of benign and cancerous breast conditions.
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A Study of the Effect of Using MRI and Mammography Before Surgery in Patients with Stage I-II Breast Cancer
Rochester, MN
The purpose of this study is to assess whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves the ability to evaluate tumors and decide what kind of surgery is best for the patient.
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A Study to Determine Molecular Mechanisms in Breast Implant Associated-Anaplastic Large Cell Lymphoma
Jacksonville, FL
The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) tumor specimens and healthy control tissue.
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Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery
Rochester, MN
This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy destroyed the breast cancer cells and may be compared to the tumor removed during surgery to check if they are the same.
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A Study to Evaluate Surgical Outcomes and Quality of Life after Breast Reconstruction
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the surgical outcomes that patients have after breast reconstruction, and to assess how reconstruction has affected their quality of life.
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A Study of to Evaluate Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast cancer in order to influence estrogen receptor (ER) signaling.
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A Study to Evaluate Surgical Sterility, the Microbiome and Infections Following Mastectomy with Immediate / Tissue Expander Reconstruction
Rochester, MN
The purpose of this study is to evaluate surgical sterility, the microbiome, and infections post mastectomy with immediate/tissue expander surgery by using OR camera recording, surgical site and/or microbiome analysis.
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Study to Evaluate Effects of Pre-Surgery Therapy on Direct-to-Implant Reconstruction as Compared to Immediate Tissue Expander-Based Reconstruction
Rochester, MN
The purpose of this study is to compare and identify different forms/regimens of chemotherapy/hormone therapy in breast cancer patients who underwent mastectomy and subsequent immediate breast reconstruction (tissue expander or direct-to-implant). Subsequently, correlate these findings to assess overall surgical and clinical outcomes.
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Open Nipple Sparing Mastectomy (NSM)
Rochester, MN
The purpose of this retrospective study is to evaluate the complication rate of prophylactic open NSM procedures through 42 days follow-up from retrospective chart review at the same investigators and institutions as those included under IDE Study protocol G190065/A001.
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Understanding the Relationship Between Benign Breast Tissue, Benign Breast Disease, and Breast Cancer Development
Jacksonville, FL
The purpose of this study is to culture human mammary cells to identify cellular characteristics associated with lobular involution status.
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A Study to Evaluate Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the safety of 5 fraction vs. 25 fraction radiation to the whole breast or post-mastectomy chest wall/reconstructed chest with regional nodal radiation.
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Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy
Jacksonville, FL; Rochester, MN; Albert Lea, MN; Mankato, MN
This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.
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A Study to Evaluate Same Day Discharge Post-mastectomy with/without Alloplastic Breast Reconstruction
Rochester, MN
In the light of the pandemic, institutions have had to take greater precautions and instigate procedures to aim to improve safety and reduce risk for patients undergoing surgery. One intiative was designed to implement a same day discharge for patients undergoing mastectomy with or without alloplastic reconstruction. This study aims to evaluate the outcomes and patient satisfaction with same day mastectomy with or without alloplastic reconstruction following COVID-19 and compare satisfaction and outcomes (e.g complications) with patients pre-COVID 19. This is part of a quality improvement project.
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Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
This randomized phase II trial studies how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer. Monoclonal antibodies, such as atezolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the tumor smaller and reduce the ...
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A Study to Evaluate the Safety of the Goldilocks Procedure with Implant-Based Reconstruction
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess outcomes, satisfaction and aesthetics of two different breast reconstruction techniques (Goldilocks alone, and Goldilocks with Implant-Based Reconstruction) and compare its safety, patient satisfaction, aesthetic evaluation and complications.
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MC230302
Jacksonville, FL
This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).
Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).
Hypothesis: Patients undergoing NSM will be willing ...
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3D-Printed Individualized External Breast Prostheses for the Post-mastectomy Patient.
Rochester, MN
This study aims to evaluate the efficacy of personalized 3D-printed external breast prostheses for patients opting out of reconstruction and assess their satisfaction with a survey.
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LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
Rochester, MN
The purpose of this study is to investigate the safety, effectiveness, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by effectiveness that will be assessed from fluorescence imaging observations and data.
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A Study to Examine Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
Jacksonville, FL
The purpose of this study is to examine how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.
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Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Jacksonville, FL
The purpose of this study is to evaluate the timing of AVB-620 administration relative to surgery on the fluorescence and accuracy of the AVB-620 imaging data to distinguish between malignant and nonmalignant tissues in women undergoing surgery with primary, nonrecurrent and nonmetastatic breast cancer.
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Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery
Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.
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Determining Molecular Drivers of Radiation Dermatitis
Jacksonville, FL
The purpose of this study is to collect (i) pre-treatment (at the time of breast cancer surgery) normal skin and (ii) on-treatment (around the third week of treatment with breast radiation) irradiated skin with clinical hallmarks of radiation dermatitis (erythema and/or dry desquamation, documented by a photograph and graded by clinical criteria).
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Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery
Rochester, MN; Scottsdale/Phoenix, AZ
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
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A Study to Evaluate Patient Satisfaction with Televisits for Surgery
Rochester, MN
The aim of this study is to identify factors that demonstrate efficiency while maintaining downstream revenue, increase surgical case yield out of clinic, and increase patient and provider satisfaction with telehealth.
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A Study Comparing Combinations of Chemotherapy for Treating Women who have Undergone Surgery for Node-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare three different combination chemotherapy regimens and evaluate how well they work in treating women who have undergone surgery for node-positive breast cancer. Drugs used in chemotherapy, such as docetaxel, doxorubicin, cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
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Evaluation of Sensibility with Targeted Nipple Areola Complex Re-innervation in Nipple Sparing Mastectomy
Scottsdale/Phoenix, AZ
To determine the effectiveness of targeted nipple areola complex (NAC) re-innervation for improving sensibility in women undergoing nipple sparing mastectomy (NSM).
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Eliminating Breast Cancer Surgery in Exceptional Responders with Neoadjuvant Systemic Therapy
Rochester, MN
The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 120 participants will be enrolled on this multicenter study. Up to 90 may take part at MD Anderson.
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A Study to Evaluate Abemaciclib for Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to examine the effects of abemaciclib on the CD8/FOXP3 ratio in chemotherapy-resistant triple negative breast cancer (TNBC) patients following neoadjuvant chemotherapy.
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Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial
Jacksonville, FL; La Crosse, WI; Rochester, MN; Eau Claire, WI
The purpose of this study is to test how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer.
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A Study of Pembrolizumab (MK-3475) Versus Placebo in Combination with Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Rochester, MN
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020."
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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Scottsdale/Phoenix, AZ
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020.
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The Mayo Clinic Breast Disease Survivors Study
Rochester, MN
This study will recruit breast cancer patients and survivors to take part in an ongoing study of the issues and concerns surrounding breast cancer survivorship. We will recruit both newly diagnosed patients as well as patients diagnosed within the past 5 years. Those who consent to the study will be asked to provide a series of questionnaires and blood samples over time. These data/samples will create a repository that will enable us to address many specific hypotheses both now and in the future. As part of the study DNA samples will be genotyped for common genetic variants ...
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A Study of the Ability to Predict Lymphedema Development Following Axillary Surgery for Breast Cancer and Its Effects on Patient Survivorship
Jacksonville, FL
The purpose of this study is to better understand the anatomy of the lymphatic structure and the molecular process that leads to the over production of lymph fluid. This proposal will begin intense lymphedema screening and identify baseline characteristics potentially predisposing someone to lymphedema, and identify molecular markers that might be altered to prevent lymphedema.
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Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery
Eau Claire, WI
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
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A Study to Evaluate Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy
Eau Claire, WI; Rochester, MN; La Crosse, WI
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on ...
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Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
Eau Claire, WI; Mankato, MN; Rochester, MN; Jacksonville, FL
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.
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A Study of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery. The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in breast cancer.
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Evaluating Surgical Treatment Related Differences in Patient Satisfaction and Health-related Quality of Life in Breast Cancer Survivors in the Long-term Survivorship Period
Rochester, MN
This study is being done to determine the long-term effects of different kinds of breast surgeries on women’s health-related quality of life from the patient’s perspective. The information will also provide information to assist in improving the quality of care given to patients.
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Pre-Op / Post-Op Hypofractionation Radiotherapy in Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of ths study is to determine the outcomes and toxicity profile of preoperative treatment including chemotherapy and hypofractionated radiotherapy for different breast cancer risk groups.
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Study of Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
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Hypofractionated Radiotherapy After Breast Conserving Surgery
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The optimal dose and fractionation regimen for whole breast irradiation, whole breast and regional nodal irradiation, and postmastectomy radiotherapy remains unknown. The goal of this phase II randomized controlled trial is to determine whether the hypofractionated proton regimens proposed are non-inferior compared with standard fractionated proton radiotherapy and therefore worthy of further investigation.
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Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy
Mankato, MN
This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.
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A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer.
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A Study to Evaluate Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer
Rochester, MN
The purpose of this study is to estimate the circulating tumor DNA (ctDNA)detection rate and mutational load in breast cancer patients with indications for regional nodal irradiation.
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Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
Rochester, MN
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and ...
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A Study of Massage Therapy Alone and in Combination with Acupuncture for Breast Cancer Patients Undergoing Autologous Tissue Reconstruction
Rochester, MN
The purpose of this study is to explore the effectiveness of massage therapy combined with acupuncture in breast cancer patients recovering from autologous tissue reconstruction with the hope that the combination will augment the benefit obtained by massage therapy alone.
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A Study to Evaluate the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Surgical Systems in Nipple Sparing Mastectomy procedures.
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Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival
Rochester, MN; Jacksonville, FL
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic ...
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Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)
Rochester, MN
The purpose of this trilal is to study a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer.
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A2B101-101: Obtaining Solid Tumor Tissue from Subjects Having Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing
Rochester, MN; Jacksonville, FL
The primary objectives for this study are:
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
- Percentage of screened subjects experiencing loss ...
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A Study to Evaluate Treating Post-Mastectomy Radiation Injury in Breast Cancer Patients with Adipose-Induced Regeneration of Breast Skin (AIR Breast)
Jacksonville, FL
The primary purpose of this study is to identify the therapeutic effect of Adipose-Induced Regeneration (AIR) in radiation-induced skin injury of post-mastectomy breast cancer patients.
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Defining the Immunologic Profile of Sentinel Lymph Nodes and Identifying the Mechanisms Responsible for Immunosuppression
Rochester, MN; Jacksonville, FL
The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.
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Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
Rochester, MN
The investigators believe that the lessons learned from studies regarding 30-day and 90-day readmission are primarily due to failure of early symptom recognition, and medical error. Through the aid of remote monitoring and early symptom detection, the hypothesis for the current proposal is that interventions can be recommended in an earlier, remote fashion that may result in earlier post-surgical discharge, prevent decompensation, and prevent increased readmissions that have been associated with decreased LOS in other surgical populations.