This phase II trial evaluates the effectiveness and safety of pegylated liposomal doxorubicin hydrochloride (liposomal doxorubicin) and carboplatin for the treatment of patients with early stage triple negative breast cancer. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell’s deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Giving liposomal doxorubicin and carboplatin in combination may be effective at treating patients with early stage triple negative breast cancer while also producing less side effects than current standard therapies.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05949021.
Locations matching your search criteria
United States
New Jersey
Elizabeth
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street CampusStatus: Active
Contact: Mridula Annette George
Phone: 732-235-9081
Jersey City
Jersey City Medical CenterStatus: Active
Contact: Mridula Annette George
Phone: 732-235-9081
Livingston
Saint Barnabas Medical CenterStatus: Active
Contact: Mridula Annette George
Phone: 732-235-9081
New Brunswick
Rutgers Cancer Institute of New JerseyStatus: Active
Contact: Mridula Annette George
Phone: 732-235-9081
Newark
Newark Beth Israel Medical CenterStatus: Active
Contact: Mridula Annette George
Phone: 732-235-9081
Somerville
Robert Wood Johnson University Hospital SomersetStatus: Active
Contact: Mridula Annette George
Phone: 732-235-9081
PRIMARY OBJECTIVE:
I. To determine the efficacy of liposomal doxorubicin and carboplatin in the adjuvant setting for early stage triple negative breast cancer (TNBC).
SECONDARY OBJECTIVE:
I. To characterize the safety and toxicity profile of the study treatment as measured by the adverse events rates.
EXPLORATORY OBJECTIVE:
I. Evaluate changes in circulating tumor DNA (ctDNA).
OUTLINE:
Patients receive liposomal doxorubicin intravenously (IV) over 90 minutes and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) at baseline and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 30 days, at 3, 6, 12, 18, and 24 months, and then every 6 months thereafter up to 5 years.
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorMridula Annette George
