OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-Stage Triple-Negative Breast Cancer.

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.