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

Other illness

• 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.
• 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.

Lab values

• 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.
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.

Other

• Pre-existing sensory neuropathy greater than grade 1.

• 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.