Share this page:

Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)

Phase: III
Status: Not Recruiting

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called SPI-2012 (also known as Rolontis™, eflapegrastim). This is a clinical trial for people who are about to start their first treatment for breast cancer. All participants in this study 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 RECOVER will also receive a medication (either pegfilgrastim or SPI-2012) that will increase the number of white blood cells in the body. This study will compare SPI-2012 (eflapegrastim) and pegfilgrastim (NDC code 55513-190-01) 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.

Principal Investigator

Shyamali Singhal, MD, PhD

Sponsor

Spectrum Pharmaceuticals, Inc.

NCT Number

NCT02953340

Contact

Kathy Miller, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4562
Kathryn_Miller@elcaminohealth.org

 

You may also be interested in...

Visitor Screener

Visitor Restrictions

A visitor policy is in effect due to more restrictive measures being taken throughout the Bay Area.
HealthPerks Banner

Sign Up for HealthPerks

Get health information, event invitations, free screenings and more delivered to your inbox.
Find a doctor who will fit you well.

Find a Doctor

Use our directory to find a doctor with an office near our Mountain View or Los Gatos campus.