A clinical trial to evaluate the safety of medicines palbociclib among African-American women with breast cancer

A clinical trial to evaluate the safety of medicines palbociclib among African-American women with breast cancer -

The first clinical trial to test a drug against cancer the newly approved specifically for African-American patients breast is now enroll in Georgetown Lombardi Comprehensive Cancer Center and soon begin five other institutions in Washington, DC, Maryland, Alabama and New Jersey.

Phase II study will assess the safety of palbociclib (Ibrance ®) African-American patients, including those who may have low blood cell counts because of "benign ethnic neutropenia." This condition is common in African Americans, but it is unclear whether it increases the risk of infection of a patient while taking palbociclib, said the study leader, Filipa Lynce, MD, a research physician at Georgetown Lombardi Comprehensive cancer Center.

the Food and Drug administration of the United States approved palbociclib in February 2016 for cancer HER2 + breast ER that propagated.

Because three quarters of 1,137 patients tested in previous clinical trials of palbociclib developed neutropenia (low white blood cell numbers) - including half of the patients who developed a more severe form of the disease. - FDA guidelines for the use palbociclib require the patient to have a normal blood cell count

This threshold requires the elimination of African American women who have "benign ethnic neutropenia ', or white blood cells in the blood below the normal to receive the drug.

leads the Lynce study explores the drug's safety in all African American women, knowing that some may have a benign ethnic neutropenia. "The assumption that African-American women with this common condition could not safely use this medication must be fully tested," said Lynce.

The study will enroll 35 patients with metastatic breast cancer at Georgetown Lombardi / MedStar Georgetown University Hospital (Washington, DC), MedStar WashingtonHospital Center (Washington, DC), MedStar Memorial Hospital Union (Baltimore, MD) andMedStar Good Samaritan Hospital (Baltimore, MD), the University of Alabama at BirminghamComprehensive cancer Center and cancer Center John Theurer Hackensack University medical Center (Hackensack, NJ).

All patients will receive palbociclib and letrozole (Femara). both agents are . pills that are taken once daily participants will be enrolled in the study for up to 13 months

the usual standard of care required to monitor and treat cancer -. Includes examinations, analysis and laboratory tests - will be conducted as part of the study and billed to the insurance of a patient. The main drug study palbociclib will be provided free for study but the second drug, letrozole, will also be charged for insurance.

Lynce applied and received a $ 0,000 grant from Pfizer, Inc., the developer of palbociclib to test the agent in African Americans.

I think this award shows how committed the company is to examine the safety of their products in the minority, "said Lynce." A staging area to the point of my research is to examine the safety and effectiveness of drugs used to treat breast cancer in populations that are not included in clinical trials.