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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.

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

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.

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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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2023-10-07
Est. Completion 2027-09-30
Phase Phase 2

Sponsor

Mridula George, MD

3 total trials

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What the Registry Record Tells You About NCT05949021

The ClinicalTrials.gov registry entry for NCT05949021 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 156-participant average among 14 other Triple Negative Breast Cancer (TNBC) trials with a reported enrollment target (81% lower). The listed sponsor is Mridula George, MD, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.