OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer (NCT05949021)
🩺 Plain-English Summary (8th-Grade Level)
This clinical trial aims to evaluate the efficacy, safety, and exploratory measures of liposomal doxorubicin and carboplatin combination therapy in the adjuvant setting for early stage triple negative breast cancer (TNBC) patients. The primary objective is to determine the effectiveness of liposomal doxorubicin and carboplatin in reducing the risk of recurrence for early stage TNBC patients. The secondary objectives involve characterizing the safety and toxicity profile of the combination therapy. Adverse events rates will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The exploratory objectives of the study focus on evaluating changes in circulating tumor DNA (ctDNA). This measure will provide insights into the potential utility of ctDNA as a biomarker for treatment response and disease progression. By addressing these objectives, the study aims to contribute to the understanding of the benefits and risks associated with liposomal doxorubicin and carboplatin combination therapy in the adjuvant setting for early stage TNBC, potentially leading to improved treatment outcomes and patient care.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (11 items).
Location: RWJBarnabas Health - Trinitas hospital and Comprehensive Center — Elizabeth, New Jersey
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- RWJBarnabas Health - Trinitas hospital and Comprehensive Center — Elizabeth, New Jersey
- RWJBarnabas Health Jersey City Medical Center — Jersey City, New Jersey
- RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood, New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital — New Brunswick, New Jersey
- RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey
- University Hospital-Newark — Newark, New Jersey
- RWJBarnabas Health - Community Medical Center — Toms River, New Jersey
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.