New chemo cocktail aims to stop triple negative breast cancer from returning
NCT ID NCT05949021
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial is testing a combination of two chemotherapy drugs, liposomal doxorubicin and carboplatin, given after surgery to people with early-stage triple negative breast cancer. The goal is to see if this treatment can reduce the risk of the cancer coming back. The study involves 30 participants and is currently active but no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- liposomal doxorubicin and carboplatin (chemotherapy drugs)
- What this could lead to
- If successful, this could offer a more effective adjuvant chemotherapy option for early-stage triple negative breast cancer, potentially lowering the chance of cancer returning after surgery.
- What could go wrong
- This is a small, early-phase (Phase 2) trial with only 30 participants, so results may not apply to all patients. Chemotherapy drugs like these can cause serious side effects, including heart damage and bone marrow suppression.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755, United States
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RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701, United States
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RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
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RWJBarnabas Health - Trinitas hospital and Comprehensive Center
Elizabeth, New Jersey, 08755, United States
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RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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University Hospital-Newark
Newark, New Jersey, 07112, United States
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