Spectrum ADVANCE: Randomized Trial to Evaluate SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC)
Sponsor: Spectrum Pharmaceuticals, Inc.
Primary Investigator: Philip Lowry, MD
Primary Study Coordinator: Cherokee Helms-Gleason, LPN
Number of Participants: 580
Length of Study: Treatment: 12 weeks Follow-up: 18months Total: 21 months
What is SPI-2012? SPI-2012 (also known as eflapegrastim) is a new medication currently being tested and has yet to receive approval from the Food and Drug Administration (FDA). SPI- 2012 increases the number of white blood cells in your body.
What is neutropenia and febrile neutropenia? White blood cells are made in the bone marrow (a spongy material inside bones) and are an important part of your immune system. A special type of white blood cell, called a neutrophil, guards against germs and helps fight infections. Neutrophils make up the majority of white blood cells. They are the first responders and quickly appear at the site of an infection.
Chemotherapy can lower the number of white blood cells in your body. If you have a low number of neutrophils, it is called neutropenia. Having neutropenia makes you more likely to get an infection because the usual mechanism to fight an infection (neutrophils) is not available. If you have neutropenia and a fever (also called febrile neutropenia), it may be the first sign of an infection.
What type of study is this? ADVANCE is a phase 3 clinical trial for people who are about to start their first treatment for breast cancer.
You may be able to participate in the ADVANCE trial if you:
Are at least 18 years old
Have confirmed early stage breast cancer
Have never received chemotherapy, radiation or a bone marrow transplant
Will be receiving docetaxel and cyclophosphamide (TC) chemotherapy
Why is the ADVANCE trial being done? The purpose of this study is to test the safety and effectiveness of an investigational medication designed to treat neutropenia (low white blood cells in your body) following chemotherapy. The study will compare SPI-2012 and pegfilgrastim (also known as Neulasta®) along with TC chemotherapy for early stage breast cancer, by collecting blood samples and looking at the number of white blood cells and neutrophils being produced by the body.
What is involved in the study? If you eligible and are willing to participate in the ADVANCE trial, you will be randomly assigned (like flipping a coin) to receive either SPI-2012 or pegfilgrastim.
You will receive TC chemotherapy every 3 weeks; this is also called a cycle of chemotherapy. TC chemotherapy will be given on Day 1 and you will return the following day to receive an injection of SPI-2012 or pegfilgrastim. This will happen 4 times (4 cycles) in about 3 months.
You will be asked to closely monitor your temperature throughout the time you are receiving TC chemotherapy and to immediately contact your doctor or emergency if you have a fever to arrange for health assessment, a blood draw and possible medical care. This is because a fever can sometimes be a sign that you have a serious infection.
During your participation in the ADVANCE trial, blood samples will also be collected to measure your white blood cell count and neutrophils. In the first cycle, these blood draws will be collected daily for about 12 days. Afterwards, they will only be collected about 5 times during each of the remaining cycles. Study staff will also continue to check on your health status during the duration of the trial.
What are the costs of the study? Study medication (SPI-2012 or Neulasta) is provided at no cost to you or your insurance company. Study related exams and evaluations is provided at no cost to you or your insurance company.
You and/or your insurance company will continue to pay for routine health care cost for the management of your cancer which may include testing such as laboratory tests, treatment drugs, administration of treatment, and visits with your provider.
What are the benefits of being in the study? Although the ADVANCE trial may or may not provide any direct benefit to you, you’ll be helping researchers better understand SPI-2012 and the results of the trial could help some people with cancer in the future. As a participant, you will still receive the same planned treatment (TC chemotherapy) that is recommended as therapy for early stage breast cancer. You will also be closely monitored by a medical team, including a study nurse and study doctor
To inquire about trial eligibility or for additional information, please contact:
UPHS - Marquette Cancer Care: 906-225-3500 toll-free: 1-800-562-9753 ext. 3922
Cherokee Helms-Gleason, LPN: 906-225-7397 toll-free: 1-800-562-9753 ext. 7397
Jodi Nease, RN: 906-225-4687 toll-free: 1-800-562-9753 ext. 4687
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