OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-Stage Triple-Negative Breast Cancer.
Primary Objective:
To determine the efficacy of liposomal doxorubicin and carboplatin in the adjuvant setting for early stage TNBC.
Secondary Objectives:
To characterize the safety and toxicity profile of the study treatment as measured by the adverse events rates.
Exploratory Objectives:
Evaluate changes in circulating tumor DNA (ctDNA)
CARBOPLATIN
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Community Medical Center
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
- Rutgers Cancer Institute of New Jersey-University Hospital
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.