Liposomal Doxorubicin and Carboplatin for the Treatment of Patients with Early Stage Triple Negative Breast Cancer, OCTANE Trial

Status: closed to accrual

This phase II trial evaluates the effectiveness and safety of pegylated liposomal doxorubicin hydrochloride (liposomal doxorubicin) and carboplatin for the treatment of patients with early stage triple negative breast cancer. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell’s deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Giving liposomal doxorubicin and carboplatin in combination may be effective at treating patients with early stage triple negative breast cancer while also producing less side effects than current standard therapies.

Inclusion Criteria

Newly diagnosed early stage TNBC with primary tumor < 2.5cm and nodal disease of N0/N1mi on final surgical pathology
Completed primary surgical treatment
Estrogen receptor (ER) ≤ 10%, progesterone receptor (PgR) ≤ 10%, HER2 0-2+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) ≤ 2.0
Prior cancers allowed if no evidence of disease in last 5 years. Prior history of ipsilateral invasive breast cancers are not allowed
Eastern Cooperative Oncology Group (ECOG) performance status of performance status (PS) 0-1
Baseline left ventricular ejection fraction (LVEF) > 50% (most recent within the last 6 months)
No prior history of treatment with anthracyclines based chemotherapy
Absolute neutrophil count (ANC) ≥ 1500/uL
Platelet count ≥ 100,000/uL
Hemoglobin ≥ 9.0 g/dL
Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) ≤ 5 X ULN
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 5 X ULN
Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage
Creatinine < 1.5 x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula
Ability to understand the nature of this study protocol and give written informed consent
Willingness and ability to comply with scheduled visits and treatment plans

Exclusion Criteria

Patients with stage III-IV breast cancer
Uncontrolled hypertension (systolic blood pressure > 190 mm Hg or diastolic blood pressure > 100 mm Hg)
Active liver disease
Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
Pre-existing sensory neuropathy > grade 1
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
Serious non-healing wound, ulcer, or bone fracture
Patient with uncontrolled and/ or active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Patient who has 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 subject from participating in the study

PRIMARY OBJECTIVE:

I. To determine the efficacy of liposomal doxorubicin and carboplatin in the adjuvant setting for early stage triple negative breast cancer (TNBC).

SECONDARY OBJECTIVE:

I. To characterize the safety and toxicity profile of the study treatment as measured by the adverse events rates.

EXPLORATORY OBJECTIVE:

I. Evaluate changes in circulating tumor DNA (ctDNA).

OUTLINE:

Patients receive liposomal doxorubicin intravenously (IV) over 90 minutes and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) at baseline and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up at 30 days, at 3, 6, 12, 18, and 24 months, and then every 6 months thereafter up to 5 years.

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Liposomal Doxorubicin and Carboplatin for the Treatment of Patients with Early Stage Triple Negative Breast Cancer, OCTANE Trial

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