Clinical Trials

Clinical trials are an extremely important component of cancer care. According to National Comprehensive Cancer Network Guidelines, "the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged." Drs. Brown and Gold actively pursues this mission. Dr. Brown is the PI (Priniciple Investigator) at Beaumont Health of many of the clinical trials offered by cooperative groups in the U.S. (NSABP, SWOG, Alliance). Drs. Brown and Gold also have access to Clinical Trials through Karmanos Cancer Institute, A National Cancer Institute Designated Cancer Center (one of two in Michigan).

Multiple clinical trials are available through the NCI (National Cancer Institute). Dr. Brown is Principle Investigator at Beaumont Hospital, Troy (Beaumont Cancer Institute) for a number of these trials. In addition the Clinical Trials offered through the Karmanos Cancer Institute, here is a list of Beaumont Health Breast Cancer related Clinical Trials available, as of January, 2020:

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 A011401 RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF WEIGHT LOSS IN ADJUVANT TREATMENT OF OVERWEIGHT AND OBESE WOMEN WITH EARLY BREAST CANCER.
ALLIANCE A011502 RAMDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER 2 NEGATIVE BREAST CANCER: THE ABC TRIAL.
ECOG-ACRIN EAY131(MATCH): MOLECULAR ANALYSIS FOR THERAPY CHOICE (MATCH).
MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW-RISK NODE-POSITIVE BREAST CANCER.
NRG BR004: A RANDOMIZED, DOUBLE-BLIND, PHASE III TRIAL OF PACLITAXEL/TRASTUZUMAB/PERTUZUMAB WITH ATEZOLIZUMAB OR PLACEBO IN FIRST-LINE HER2-POSITIVE METASTATIC 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.
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.
SWOG S1706: TO COMPARE THE INVASIVE DISEASE-FREE SURVIVAL (IDFS) OF PATIENTS WITH INFLAMMATORY BREAST CANCER RECEIVING CONCURRENT ADMINISTRATION OF OLAPARIB WITH STANDARD DOSES OF RADIOTHERAPY TO THE CHEST WALL AND REGIONAL LYMPH NODES COMPARED TO STANDARD DOSES OF RADIOTHERAPY ALONE TO THE CHEST WALL AND REGIONAL LYMPH NODES.

Industry Sponsored Clinical Trials

Comprehensive breast care is committed to providing our patients with access to as many clinical trials as possible. The trials listed here are sponsored by industry or commercial companies. These trials are also important in continuing the quest for the best and most appropriate options for our patients. Many of these trials will be "practice changing" with tremendous impact on patient care.

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).

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

Genetic testing underutilized

Medneon iGAP Registry

A retrospective and prospective observational registry documenting utility, clinical impact and patient experience for individuals with cancer, at risk of cancer and unaffected family members, who obtain genetic testing.

(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