Clinical Trials

• ALLIANCE A011202: A RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF AXILLARY LYMPH NODE DISSECTION IN BREAST CANCER PATIENTS (CT1-3 N1) WHO HAVE POSITIVE SENTINEL LYMPH NODE DISEASE AFTER NEOADJUVANT CHEMOTHERAPY).
• ALLIANCE FOUNDATION AFT-25 (COMET): COMET TRIAL-COMPARISON OF OPERATIVE TO MONITORING AND ENDOCRINE THERAPY (COMET) TRIAL FOR LOW RISK DCIS: A PHASE III PROSPECTIVE RANDOMIZED TRIAL 9AAFT-25)
• ECOG-ACRIN EAY131(MATCH): MOLECULAR ANALYSIS FOR THERAPY CHOICE (MATCH)
• NRG-BR002: A PHASE IIR/III TRIAL OF STANDARD OF CARE THERAPY WITH OR WITHOUT STEREOTACTIC BODY RADIOTHERAPY (SBRT) AND/OR SURGICAL ABLATION FOR NEWLY OLIGOMETASTATIC BREAST CANCER.
• NSABP B-51: A RANDOMIZED PHASE III CLINICAL TRIAL EVALUATING POST-MASTECTOMY CHESTWALL AND REGIONAL NODAL XRT AND POST-LUMPECTOMY REGIONAL NODAL XRT IN PATIENTS WITH POSITIVE AXILLARY NODES BEFORE NEOADJUVANT CHEMOTHERAPY WHO CONVERT TO PATHOLOGICALLY NEGATIVE AXILLARY NODES AFTER NEOADJUVANT CHEMOTHERAPY.
• ALLIANCE A011502 RAMDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER 2 NEGATIVE BREAST CANCER: THE ABC TRIAL
• ALLIANCE A011401 RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF WEIGHT LOSS IN ADJUVANT TREATMENT OF OVERWEIGHT AND OBESE WOMEN WITH EARLY BREAST CANCER
• Seattle Genetics ONT-380-206 (HER2CLIMB) PHASE II RANDOMIZED, DOUBLE-BLINDED, CONTROLLED STUDY OF ONT-380 VS. PLACEBO IN COMBINATION WITH CAPECITABINE AND TRASTUZUMAB IN PATIENTS WITH PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HER2+ BREAST CARCINOMA
• HIC# 2018-226: HYPOFRACTIONATED REGIONAL NODAL IRRADIATION IN BREAST CANCER
• HIC# 2017-210: PRAGMATIC PHASE III RANDOMIZED TRIAL OF PROTON VS. PHOTON THERAPY FOR PATIENTS WITH NON-METASTATIC BREAST CANCER RECEIVING COMPREHENSIVE NODAL RADIATION: A RADIOTHERAPY COMPARATIVE EFFECTIVENESS (RADCOMP) CONSORTIUM TRIAL

• NSABP B-55/BIG 6-13: A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED MULTI-CENTRE PHASE III STUDY TO ASSESS THE EFFICACY AND SAFETY OF OLAPARIB VERSUS PLACEBO AS ADJUVANT TREATMENT TREATMENT IN PATIENTS WITH GERMLINE BRCA1/2 MUTATIONS AND HIGH RISK HER2 NEGATIVE PRIMARY BREAST CANCER WHO HAVE COMPLETED DEFINITIVE LOCAL TREATMENT AND NEOADJUVANT OR ADJUVANT CHEMOTHERAPY.
• SWOG S1207/NSABP B-53: PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL EVALUATING THE USE OF ADJUVANT ENDOCRINE THERAPY +/- ONE YEAR OF EVEROLIMUS IN PATIENTS WITH HIGH-RISK, HORMONE RECEPTOR-POSITIVE AND HER2/NEU NEGATIVE BREAST CANCER.
• SWOG S1416: PHASE II RANDOMIZED PLACEBO-CONTROLLED TRIAL OF CISPLATIN WITH OR WITHOUT ABT-888 (VELIPARIB) IN METASTATIC TRIPLE-NEGATIVE BREAST CANCER AND/OR BRCA MUTATION-ASSOCIATED BREAST CANCER (Brain Mets Only)
• SWOG S1418/BR006: A RANDOMIZED PHASE III TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MK-3475 AS ADJUVANT THERAPY FOR TRIPLE RECEPTOR-NEGATIVE BREAST CANCER WITH GREATER THAN 1CM RESIDUAL INVASIVE CANCER OR POSITIVE LYMPH NODES (>PN1MIC) AFTER NEOADJUVANT CHEMOTHERAPY
• WAKE FOREST 97415 (UPBEAT): UNDERSTANDING AND PREDICTING BREAST CANCER EVENTS AFTER TREATMENT (UPBEAT)
• CTSU DCP-001: USE OF A CLINICAL TRIAL SCREENING TOOL TO ADDRESS CANCER HEALTH DISPARITIES IN THE NCI COMMUNITY ONCOLOGY RESEARCH PROGRAM (NCORP)
  Beaumont’s NCI Community Oncology Research Program (NCORP) is a project supported by Award 1UG1CA190002 from the National Cancer Institute. Additional support is given by the Beaumont Research Institute and Beaumont Health System. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.

DCISionRT Registry

Registry objective: Create a database of patients, test results, and treatment decisions which may be queried to determine the potential clinical utility of the DCISionRT test in the management of DCIS, as it is broadly incorporated into clinical practice.

Primary Registry endpoint is: Understanding the difference in physician treatment recommendations for patients diagnosed with DCIS and treated with breast conserving surgery based on availability of the DCISionRT test results (biologic factors).

Lumicell Feasibility Study Phase C: Expansion Into Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects with Breast Cancer.

Sudy Objectives:

1. Complete hands-on training of the surgeons and clinical staff that will be participating in the pivotal study to evaluate the efficacy and safety of the LUM Imaging System in breast cancer surgeries 
2. Identify and address any site-specific or user-specific issues for using the LUM Imaging System in breast cancer surgeries 
3. Collect safety and efficacy data 

TME Universal Gene Study

Project Goal:

Understand the incidence of deleterious mutations in the general breast cancer patient population and whether criteria by which patients are currently selected for testing are adequate. A total of 1000 patients will be accrued across 15 to 20 breast surgery sites and tested with Invitae’s 80-gene multi-cancer panel (participating clinicians can also select to receive STAT results upfront for up to 9 genes to aid in surgical decisions). Target accrual for each site is 50 patients (25 in-criteria and 25 out-of-criteria patients).

THIS STUDY IS CLOSED

(The ‘NEAT’ Registry) Paradigm/TME NeoAdjuvant Breast Registry

This is a prospective, observational, case-only study linking molecular genomic test or circulating tumor molecular profiles to treatment response, recurrence free survival (RFS), anddistant metastases free survival (DMFS) in patients who have been diagnosed with breastcancer and who are treated with neo-adjuvant therapy. Only patients who receive neoadjuvant therapy and molecular genomic profile testing will participate.

• All patients with breast cancer who are selected for neo adjuvant therapy and who have had genomic molecular testing will be included
  • Paradigm PCDx(tissue collected during biopsy and sent after biopsy for analysis)
• Data to be collected includes:
  • Patient demographics and diagnosis, test results and neo-adjuvant treatment plan;
  • Immediate post treatment plan and results, including what treatment/s employed and pathologic results;
  • Patient interim follow up including status of breast cancer and patient at a 1 and then 3 year time period

Biozorb Registry

Registry Objectives: To document findings and outcomes for patients who have the BioZorb surgical tissue marker implanted following partial mastectomy or “lumpectomy” in a broad spectrum of clinical practice settings.

Registry Endpoints:

1. Surgical: identify the surgical sub-groups that physicians choose for implantation of the BioZorb; understand various cavity closure techniques that are used following tumor excision and how these techniques are utilized, and monitor surgical outcomes such as wound healing, cosmetic outcomes and surgeon satisfaction.
2. Radiation Oncology: identify the various types of radiation therapy delivered following lumpectomy, record the planned treatment volumes of tissue treated and document the utility of BioZorb for treatment planning and delivery.
3. Patient Satisfaction: patients rate their overall satisfaction with the breast appearance, patient acceptance, and treatment outcomes.