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OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer
Sponsor: Mridula George, MD
Summary
This clinical trial aims to evaluate the efficacy, safety, and exploratory measures of liposomal doxorubicin and carboplatin combination therapy in the adjuvant setting for early stage triple negative breast cancer (TNBC) patients. The primary objective is to determine the effectiveness of liposomal doxorubicin and carboplatin in reducing the risk of recurrence for early stage TNBC patients. The secondary objectives involve characterizing the safety and toxicity profile of the combination therapy. Adverse events rates will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The exploratory objectives of the study focus on evaluating changes in circulating tumor DNA (ctDNA). This measure will provide insights into the potential utility of ctDNA as a biomarker for treatment response and disease progression. By addressing these objectives, the study aims to contribute to the understanding of the benefits and risks associated with liposomal doxorubicin and carboplatin combination therapy in the adjuvant setting for early stage TNBC, potentially leading to improved treatment outcomes and patient care.
Official title: OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple Negative Breast Cancer
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-10-07
Completion Date
2027-09-30
Last Updated
2025-11-14
Healthy Volunteers
No
Conditions
Interventions
Combination of liposomal doxorubicin
Combination of liposomal doxorubicin 30 milligrams per square meter and carboplatin (area under the curve 5), administered every 4 weeks for 4 cycles.
Locations (8)
RWJBarnabas Health - Trinitas hospital and Comprehensive Center
Elizabeth, New Jersey, United States
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States
University Hospital-Newark
Newark, New Jersey, United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States