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OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer
NCT05949021 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Combination of liposomal doxorubicin
Study Locations (8)
New Jersey
- RWJBarnabas Health - Trinitas hospital and Comprehensive Center — Elizabeth
- RWJBarnabas Health Jersey City Medical Center — Jersey City
- RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood
- Rutgers Cancer Institute of New Jersey — New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospital — New Brunswick
- RWJBarnabas Health - Newark Beth Israel Medical Center — Newark
- University Hospital-Newark — Newark
- RWJBarnabas Health - Community Medical Center — Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-10-07 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05949021
The ClinicalTrials.gov registry entry for NCT05949021 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mridula George, MD, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Triple Negative Breast Cancer (TNBC) appearing as the primary indexed condition, and to 1 intervention — of which Combination of liposomal doxorubicin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05949021 reports 8 study locations spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05949021 about?
NCT05949021 is a clinical study titled "OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer". 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 liposoma...
What is the current status of trial NCT05949021?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-10-07. Estimated completion is 2027-09-30.
What conditions does trial NCT05949021 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer (TNBC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05949021?
The interventions under investigation include: Combination of liposomal doxorubicin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05949021?
This trial is sponsored by Mridula George, MD, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05949021 being conducted?
This trial has 8 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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