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

NCT05949021 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 042304Pro2023001280
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

Brief 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

Triple Negative Breast Cancer (TNBC)

Keywords

Liposomal doxorubicin; Carboplatin; Triple negative breast cancer (TNBC); Adjuvant therapy; Multicenter; Phase II clinical trial

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS) Rate

  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 participants enrolled in the clinical trial. DFS Rate (%) = (Number of participants with no disease recurrence or progression / Total number of participants enrolled) × 100 A higher DFS rate indicates a greater efficacy of liposomal doxorubicin and carboplatin as an adjuvant treatment, suggesting their ability to delay or prevent disease recurrence or progression in participants. A higher DFS rate implies a better prognosis and improved disease control in the adjuvant setting.

  From the start of the study up to 5 years

Secondary Outcomes (1)

• Safety and Toxicity Profile of the Study Treatment as measured by Adverse Events Rates and Common Terminology Criteria for Adverse Events version 5 (CTCAE v.5)

  From the start of the study up to 5 years

Other Outcomes (1)

• Changes in Circulating Tumor DNA (ctDNA) Levels. Monitoring ctDNA Dynamics Pre and Post Treatment

  Baseline and (on cycle four) at sixteen weeks,6,12,18,24 months up to five years post treatment

Study Arms (1)

Liposomal doxorubicin and Carboplatin

EXPERIMENTAL

Combination of liposomal doxorubicin 30milligrams per square meter (mg/m2) and carboplatin area under the curve 5 (AUC 5), administered every four weeks for four cycles. Participants with triple-negative breast cancer (TNBC): 1. Completed breast surgery and sentinel lymph node biopsy 2. Tumor size less than2.5 and NO/ N1mi disease

Drug: Combination of liposomal doxorubicin

Interventions

Combination of liposomal doxorubicin DRUG

Combination of liposomal doxorubicin 30 milligrams per square meter and carboplatin (area under the curve 5), administered every 4 weeks for 4 cycles.

Liposomal doxorubicin and Carboplatin

Eligibility Criteria

• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 five times the ULN.

You may not qualify if:

• Participants with stage III-IV breast cancer.
• Uncontrolled hypertension, defined as systolic blood pressure greater than 190 mm Hg or diastolic blood pressure greater than 100 mm Hg.
• Active liver disease.
• Any condition, including the presence of laboratory abnormalities that, in the investigator's opinion, would place the participant at an unacceptable risk if they were to participate in the study.
• Pre-existing sensory neuropathy greater than grade 1.
• Clinically significant cardiac disease, such as congestive heart failure, symptomatic coronary artery disease, and uncontrolled cardiac arrhythmias, or a history of myocardial infarction within the last six months.
• Presence of a serious non-healing wound, ulcer, or bone fracture.
• Participants with uncontrolled and/or active infection with HIV, Hepatitis B, or Hepatitis C.
• Participants with a history of allergy or hypersensitivity to any of the study drugs.
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.

Sponsors & Collaborators

• Mridula George, MD: lead

Study Sites (8)

RWJBarnabas Health - Trinitas hospital and Comprehensive Center

Elizabeth, New Jersey, 08755, United States

Location

RWJBarnabas Health Jersey City Medical Center

Jersey City, New Jersey, 07302, United States

Location

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

University Hospital-Newark

Newark, New Jersey, 07112, United States

Location

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, 08755, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mridula George, MD

  Cancer Institute of New Jersey Rutgers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 17, 2023
• Study Start: October 7, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)