Combination therapy of liposomal doxorubicin and carboplatin for early-stage triple-negative breast cancer

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

This study is testing a new combination of two cancer drugs, liposomal doxorubicin and carboplatin, to see if it can help people with early-stage triple-negative breast cancer reduce the chance of their cancer coming back.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sex: Female
• Sponsor: Rutgers, The State University of New Jersey (other)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 8 sites (Elizabeth, New Jersey and 7 other locations)
• Trial ID: NCT05949021 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination therapy using liposomal doxorubicin and carboplatin as adjuvant treatment for patients with early-stage triple-negative breast cancer (TNBC). The primary goal is to determine the effectiveness of this therapy in reducing the risk of cancer recurrence. Secondary objectives include assessing the safety and toxicity profile of the treatment, as well as exploring the potential of circulating tumor DNA (ctDNA) as a biomarker for treatment response. The study aims to provide insights into the benefits and risks associated with this novel combination therapy.

Who should consider this trial

Good fit: Ideal candidates for this study are newly diagnosed early-stage TNBC patients with specific tumor characteristics and who have completed primary surgical treatment.

Not a fit: Patients with advanced-stage TNBC or those who have previously received anthracycline-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of recurrence in early-stage TNBC patients while potentially offering a more tolerable side effect profile.

How similar studies have performed: Previous studies have shown promising results with similar combination therapies in the neoadjuvant setting, indicating potential for success in this adjuvant approach.

Eligibility 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.

Where this trial is running

Elizabeth, New Jersey and 7 other locations

• RWJBarnabas Health - Trinitas hospital and Comprehensive Center — Elizabeth, New Jersey, United States (RECRUITING)
• RWJBarnabas Health Jersey City Medical Center — Jersey City, New Jersey, United States (RECRUITING)
• RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States (RECRUITING)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (RECRUITING)
• RWJBarnabas Health - Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (RECRUITING)
• RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States (RECRUITING)
• University Hospital-Newark — Newark, New Jersey, United States (RECRUITING)
• RWJBarnabas Health - Community Medical Center — Toms River, New Jersey, United States (RECRUITING)

Study contacts

• Principal investigator: Mridula George, MD — Cancer Institute of New Jersey Rutgers
• Study coordinator: Mridula A George, MD

Conditions: Triple Negative Breast Cancer, Liposomal doxorubicin, Carboplatin, Triple negative breast cancer, Adjuvant therapy, Multicenter, Phase II clinical trial