Eflapegrastim (also known as SPI-2012) is a new medication currently being tested and has yet to receive approval from the Food and Drug Administration (FDA).
The ADVANCE Study
ADVANCE is a clinical study for people who are about to start their first treatment for breast cancer.
All participants in ADVANCE will receive chemotherapy treatment with docetaxel and cyclophosphamide (also called TC chemotherapy). Treatment with TC chemotherapy may weaken your body’s ability to fight infections by reducing the number of white blood cells in your body. Because of this, all patients in ADVANCE will also receive a medication (either pegfilgrastim or eflapegrastim) that can increase the number of white blood cells in the body.
The purpose of this study is to compare eflapegrastim and pegfilgrastim (also known as Neulasta®*) while you receive 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.
Who can participate in the ADVANCE study?
You may be able to participate 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
You should discuss with your doctor whether you might be eligible to participate in ADVANCE. More details on what to expect if you participate in ADVANCE can be found in the informed consent for the study. Your doctor or study nurse can review this information with you.
Qualified participants will receive:
- Eflapegrastim or Neulasta® at no cost to the participant
- Study-related exams and evaluations at no cost to the participant
- Participants may receive reimbursement for time, travel, parking, and inconvenience as related to participation in this study.
What is 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 are Clinical Studies?
Clinical studies are carefully supervised and monitored research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies may also show which medical approaches work best for certain illnesses or groups of people.
The purpose of clinical studies is research, so studies are designed to follow strict scientific standards with the goals of protecting patients and helping to produce reliable study results. Results from clinical studies may be important and have the potential to advance medical knowledge and help improve patient care. However, study results are not guaranteed and may not improve patient care for study participants, so it is important that you read and understand the patient consent materials that are provided to you prior to enrolling.
Participation in a clinical research study is voluntary and a personal decision that should be made after talking with your doctor and family.
To see if the study is ongoing at a location near you,
Additional Information regarding the study can be found at:
*Disclaimer Third Parties
All product and company names are trademarksTM or registered® trademarks of their respective holders. Use of them does not imply any affiliation, approval, license or endorsement by them.
Neulasta® is a registered trademark of Amgen Inc.