St Elizabeths Medical Center

You are a candidate for this study if you have Carotid Artery Disease. 
Your carotid arteries are a pair of blood vessels in your neck that carry blood from your heart to your head and brain. These vessels can become narrowed or blocked by a buildup of plaque called a stenosis. A stenosis may lead to a stroke, which happens when blood flow to a part of the brain is stopped. A stroke is sometimes called a “brain attack.” If blood flow is stopped for longer than a few seconds, the brain cannot get 
blood and oxygen. Brain cells can die, causing permanent damage.

The most common treatment for severe carotid artery disease is a 
surgery called Carotid Endarterectomy (CEA). Your surgeon will make an incision on 
your neck to access the affected artery, open it and remove the plaque. Your surgeon will then close the artery and the incision in your neck using stitches. 

There are situations where a CEA cannot be performed, for example if you have other health conditions that make surgery too risky. Another option is a procedure called transfemoral carotid angioplasty and stenting (CAS). This minimally invasive alternative allows your physician to complete the procedure through a tube placed into the artery in your thigh. 

First, a protection device is placed next to the diseased area of the vessel, to help prevent any pieces of plaque from traveling towards your brain. Then, a small balloon is advanced to the narrowed part of your artery. Your surgeon will inflate the balloon, compressing the plaque, and then place a small elastic-like scaffold tube called a stent in order to cover the plaque and keep the artery open. Widening the narrowed 
portion of the artery may reduce the risk of stroke in the future. 

The TCAR Procedure 

A potential complication of both surgery and stenting is a stroke during the procedure itself. Studies have shown a higher risk of stroke during stenting as compared to 
surgery. The TCAR Procedure using the ENROUTE® Transcarotid Neuroprotection System is designed to reduce the risk of stroke while inserting the ENROUTE Transcarotid Stent. The TCAR procedure is performed through a small incision at your neckline just above your clavicle. This incision is much smaller than a typical CEA incision. 

Your surgeon will place a tube directly into your carotid artery and connect it to a system that will direct blood flow away from your brain, to protect against plaque that may come loose reaching your brain. Your blood will flow through the system and any material will be captured in a filter. Your filtered blood will then be returned through a 
second tube in your upper leg. After the stent is placed successfully, flow reversal is turned off and blood flow resumes in its normal direction.
 

This study is being conducted by the Alliance for Clinical Trials in Oncology. The Alliance is part of a national research network funded by the National Cancer Institute (NCI). The study will enroll more than 3,000 patients with breast cancer in the United States and Canada. Participants will be randomly assigned (like the flip of a coin) to one of two groups: Weight Loss Intervention Group- Takes part in a telephone-based weight loss program OR Health Education Group- Receives mail or online information about breast cancer topics

Participants will be randomized (like flipping a coin) to one of two arms: Arm 1 - anticoagulation therapy with a low molecular weight heparin (LMWH) alone or followed by warfarin (the usual approach). Arm 2 - anticoagulation therapy with a direct oral anticoagulant (DOAC) (the “study approach”). All of the medications used in this study have already been FDA-approved to treat blood clots. Therapy with a DOAC is already FDA-approved for use as anticoagulation therapy, but DOACs have not been studied extensively in patients with cancer. This study will allow the researchers to gather information about whether anticoagulation therapy with a LMWH alone or followed by warfarin is better, the same, or worse than anticoagulation therapy with a DOAC in patients with cancer.

Traditionally, Taxol chemotherapy administered every 2 weeks (called “dose dense”) includes Neulasta (Pegfilgrastim) the day after treatment to speed the recovery of the white blood cell count in order to maximize the chances that the next cycle of chemotherapy can be given on time. In this research study, we are testing the safety and feasibility of delivering 4 cycles of dose-dense Taxol without the use of Neulasta as a growth factor support. We want to see if Neulasta is necessary during this phase of chemotherapy and if there are less side effects without its use. If you are found to need Neulasta (for example, because of low blood counts), the study has guidance for your study doctor for you to still be able to receive it.

This study has two study groups. Group 1 will receive the study drug, aspirin at 300 mg per day, which is a dose that is available over the counter without a prescription. Group 2 will receive a placebo, a pill that looks like the study drug, but contains no medication. Aspirin or placebo will be taken daily for 5 years. People who were recommended hormonal therapy will continue their hormonal therapy as directed.

• Visit www.abctrial.org for more information. • Contact Wendy Loeser, RN with any questions you may have.