Active — Not RecruitingPhase 2

OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer

United States30 participantsStarted 2023-10-07

Plain-language 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.

Who can participate

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Newly diagnosed early stage triple negative breast cancer (TNBC) with a primary tumor size less than 2.5cm and nodal disease of N0/N1mi on final surgical pathology. * Patients who have completed primary surgical treatment. * Estrogen receptor (ER) expression of 20% or less, progesterone receptor (PgR) expression of 20% or less, and human epidermal growth factor receptor 2 (HER2) status 0-2+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) result of 2.0 or less. * Participants with a history of prior cancers are allowed if there is no evidence of disease within the last five years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Baseline left ventricular ejection fraction (LVEF) greater than 50% (most recent measurement within the last 5 years). * No prior history of treatment with anthracycline-based chemotherapy. * Adequate bone marrow function: * Absolute neutrophil count (ANC) greater than or equal to 1500/uL. * Platelet count greater than or equal to 100,000/uL. * Hemoglobin level greater than or equal to 9.0 g/dL. * Adequate hepatic function: * Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN). * Aspartate aminotransferase (AST) levels (also known as serum glutamic-oxaloacetic transaminase, SGOT) less than or equal to 5 times the ULN. * Alanine aminotransferase (ALT) levels (also known as serum glutamic-pyruvic transaminase, SGPT) less than or equal to fi…

What they're measuring

Disease-Free Survival (DFS) Rate

Timeframe: From the start of the study up to 5 years

Trial details

NCT IDNCT05949021

SponsorMridula George, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

View on ClinicalTrials.gov More Triple Negative Breast Cancer (TNBC) trials

Plain-language summary

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.