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NCT05949021 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Triple Negative Breast Cancer (TNBC), sponsored by Mridula George, MD.

Compiled by PlainTrial · August 8, 2026

Active
Registry status: Phase 2
Development phase: 30
Enrollment target: 8
Study locations

NCT05949021: Active Phase 2 study of Triple Negative Breast Cancer (TNBC), sponsored by Mridula George, MD.

NCT05949021 is a Phase 2 study of Triple Negative Breast Cancer (TNBC) that is active but no longer recruiting, run by Mridula George, MD. The registered enrollment target is 30 participants, below the 156-participant average among 14 other Triple Negative Breast Cancer (TNBC) trials with a reported enrollment target (81% lower). The trial reports 8 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05949021, a Phase 2 study of Triple Negative Breast Cancer (TNBC), is active but no longer recruiting, sponsored by Mridula George, MD.

ACTIVE NOT RECRUITING
Registry status: Phase 2
Development phase: 30 participants
Enrollment target: 8
Study locations

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.

Primary Outcome

The disease-free survival (DFS) rate is used to evaluate the efficacy of liposomal doxorubicin and carboplatin in the adjuvant setting. It assesses the proportion of participants who remain free from disease recurrence or progression after receiving the combination treatment as an adjuvant therapy for their cancer. DFS rate is calculated by dividing the number of participants who have not experienced disease recurrence or progression within a specified timeframe by the total number of participa

Conditions Studied

Triple Negative Breast Cancer (TNBC)

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

Mridula George, MD

3 total trials

What the registry record for NCT05949021 still lists

NCT05949021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 156-participant average among 14 other Triple Negative Breast Cancer (TNBC) trials with a reported enrollment target (81% lower).

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.

NCT05949021 lists 8 locations in 1 state (New Jersey).

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).

What interventions are being tested in trial NCT05949021?

The interventions under investigation include: Combination of liposomal doxorubicin (DRUG).

Who is sponsoring clinical trial NCT05949021?

This trial is sponsored by Mridula George, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Triple Negative Breast Cancer (TNBC)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05949021's enrollment target sits among peer trials

30 14th of 14 higher than 1 of 14 other Triple Negative Breast Cancer (TNBC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Triple Negative Breast Cancer (TNBC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05949021, the US trial registry maintained by the National Library of Medicine. NCT05949021 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.