ACTIVE_NOT_RECRUITING

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

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Conditions

Triple Negative Breast Cancer (TNBC)Liposomal doxorubicinCarboplatinAdjuvant therapyMulticenterPhase II clinical trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-07
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05949021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  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.
  2. * Patients who have completed primary surgical treatment.
  3. * 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.
  4. * Participants with a history of prior cancers are allowed if there is no evidence of disease within the last five years.
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  6. * Baseline left ventricular ejection fraction (LVEF) greater than 50% (most recent measurement within the last 5 years).
  7. * No prior history of treatment with anthracycline-based chemotherapy.
  8. * Adequate bone marrow function:
  9. * Absolute neutrophil count (ANC) greater than or equal to 1500/uL.
  10. * Platelet count greater than or equal to 100,000/uL.
  11. * Hemoglobin level greater than or equal to 9.0 g/dL.
  12. * Adequate hepatic function:
  13. * Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN).
  14. * Aspartate aminotransferase (AST) levels (also known as serum glutamic-oxaloacetic transaminase, SGOT) less than or equal to 5 times the ULN.
  15. * Alanine aminotransferase (ALT) levels (also known as serum glutamic-pyruvic transaminase, SGPT) less than or equal to five times the ULN.
  16. * Participants with biliary obstruction must have restored biliary flow through the placement of an endoscopic common bile duct stent or percutaneous drainage.
  17. * 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.
  18. * Ability to understand the nature of the study protocol and provide written informed consent.
  19. * Willingness and ability to comply with scheduled visits and treatment plans.
  1. * Participants with stage III-IV breast cancer.
  2. * Uncontrolled hypertension, defined as systolic blood pressure greater than 190 mm Hg or diastolic blood pressure greater than 100 mm Hg.
  3. * Active liver disease.
  4. * 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.
  5. * Pre-existing sensory neuropathy greater than grade 1.
  6. * 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.
  7. * Presence of a serious non-healing wound, ulcer, or bone fracture.
  8. * Participants with uncontrolled and/or active infection with HIV, Hepatitis B, or Hepatitis C.
  9. * Participants with a history of allergy or hypersensitivity to any of the study drugs.
  10. * Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.

Contacts and Locations

Principal Investigator

Mridula George, MD
PRINCIPAL_INVESTIGATOR
Cancer Institute of New Jersey Rutgers

Study Locations (Sites)

RWJBarnabas Health - Trinitas hospital and Comprehensive Center
Elizabeth, New Jersey, 08755
United States
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302
United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
University Hospital-Newark
Newark, New Jersey, 07112
United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
United States

Collaborators and Investigators

Sponsor: Mridula George, MD

  • Mridula George, MD, PRINCIPAL_INVESTIGATOR, Cancer Institute of New Jersey Rutgers

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-07
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-10-07
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • Liposomal doxorubicin
  • Carboplatin
  • Triple negative breast cancer (TNBC)
  • Adjuvant therapy
  • Multicenter
  • Phase II clinical trial

Additional Relevant MeSH Terms

  • Triple Negative Breast Cancer (TNBC)