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Active, not recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05949021

Public ClinicalTrials.gov record NCT05949021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 11:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05949021
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Mridula George, MD
Other
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 6, 2023
Primary completion
Sep 29, 2027
Completion
Sep 29, 2027
Last update posted
Nov 13, 2025

2023 – 2027

United States locations

U.S. sites
8
U.S. states
1
U.S. cities
6
Facility City State ZIP Site status
RWJBarnabas Health - Trinitas hospital and Comprehensive Center Elizabeth New Jersey 08755
RWJBarnabas Health Jersey City Medical Center Jersey City New Jersey 07302
RWJBarnabas Health - Monmouth Medical Center Southern Campus Lakewood New Jersey 08701
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08903
RWJBarnabas Health - Robert Wood Johnson University Hospital New Brunswick New Jersey 08903
RWJBarnabas Health - Newark Beth Israel Medical Center Newark New Jersey 07112
University Hospital-Newark Newark New Jersey 07112
RWJBarnabas Health - Community Medical Center Toms River New Jersey 08755

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05949021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 13, 2025 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05949021 live on ClinicalTrials.gov.

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