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

• Status: Recruiting
• Trial end date: 2027-09-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mridula George, MD
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• 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.

• Participants with biliary obstruction must have restored biliary flow through the placement of an endoscopic common bile duct stent or percutaneous drainage.

• Adequate renal function, with a creatinine level less than 1.5 times the institutional ULN or a calculated creatinine clearance greater than or equal to 50 mL/min using the Cockcroft-Gault formula.

• Ability to understand the nature of the study protocol and provide written informed consent.

• Willingness and ability to comply with scheduled visits and treatment plans.

Exclusion Criteria:

• 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.