Trial Title:
OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer
NCT ID:
NCT05949021
Condition:
Triple Negative Breast Cancer (TNBC)
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Doxorubicin
Liposomal doxorubicin
Conditions: Keywords:
Liposomal doxorubicin
Carboplatin
Triple negative breast cancer (TNBC)
Adjuvant therapy
Multicenter
Phase II clinical trial
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Combination of liposomal doxorubicin
Description:
Combination of liposomal doxorubicin 30 milligrams per square meter and carboplatin (area
under the curve 5), administered every 4 weeks for 4 cycles.
Arm group label:
Liposomal doxorubicin and Carboplatin
Summary:
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.
Detailed description:
Background Triple negative breast cancer (TNBC) is a subtype of breast cancer
characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and
human epidermal growth factor receptor 2 (HER2) expression. TNBC is associated with a
higher risk of recurrence and poorer prognosis compared to other breast cancer subtypes.
Currently, the standard of care for early stage TNBC includes adjuvant chemotherapy,
typically consisting of anthracyclines and taxanes. However, this regimen is associated
with significant toxicities and adverse effects.
This clinical trial aims to evaluate the combination of liposomal doxorubicin and
carboplatin as an adjuvant therapy for patients with early stage TNBC. Previous studies
conducted in the neoadjuvant setting have shown promising results with this combination,
indicating a reduction in the risk of recurrence. Additionally, the combination has
demonstrated a more favorable tolerability profile compared to the current standard of
care. Therefore, this trial seeks to assess the efficacy and safety of liposomal
doxorubicin and carboplatin in the adjuvant setting for TNBC.
The primary objective of this clinical trial is to determine the efficacy of liposomal
doxorubicin and carboplatin as adjuvant therapy for early stage TNBC. The efficacy will
be measured by evaluating the recurrence-free survival (RFS) rate at a specified time
point.
The secondary objectives of this study include: Characterizing the safety and toxicity
profile of the combination therapy, as measured by the incidence and severity of adverse
events using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Assessing the overall survival (OS) rate in patients receiving liposomal doxorubicin and
carboplatin. Evaluating the pathological complete response (pCR) rate following the
treatment regimen. Analyzing the disease-free survival (DFS) rate in patients treated
with the combination therapy. In addition to the primary and secondary objectives, this
study also aims to explore the following: Investigating changes in circulating tumor DNA
(ctDNA) levels as a potential biomarker for treatment response and disease progression.
Exploring correlations between specific genetic markers and treatment outcomes.
This study is a multicenter, open-label, phase II clinical trial. The study will enroll
patients with early stage TNBC who have undergone surgical resection of the primary
tumor. Patients in the study will receive adjuvant therapy consisting of liposomal
doxorubicin and carboplatin. The dosing and administration schedule will be determined
based on established guidelines and previous studies.
The sample size calculation will be based on statistical considerations, taking into
account the primary endpoint of recurrence-free survival. A predetermined number of
patients will be required to achieve adequate statistical power.
Eligible patients will be enrolled and undergo baseline assessments, including medical
history, physical examination, laboratory tests, and imaging studies. Treatment will be
initiated according to the predetermined dosing and administration schedule. Patients
will be closely monitored throughout the study for treatment response, adverse events,
and disease recurrence.
Follow-up visits will be scheduled at specified time intervals to assess long-term
outcomes and collect additional data.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
women
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
RWJBarnabas Health - Trinitas hospital and Comprehensive Center
Address:
City:
Elizabeth
Zip:
08755
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula A George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health Jersey City Medical Center
Address:
City:
Jersey City
Zip:
07302
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula A George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Address:
City:
Lakewood
Zip:
08701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula A George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula A George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Robert Wood Johnson University Hospital
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula A George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Newark Beth Israel Medical Center
Address:
City:
Newark
Zip:
07112
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mridula A George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
University Hospital-Newark
Address:
City:
Newark
Zip:
07112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mridula A George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Community Medical Center
Address:
City:
Toms River
Zip:
08755
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mridula A George, MD
Phone:
732-235-9081
Email:
mridula@cinj.rutgers.edu
Start date:
October 7, 2023
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Mridula George, MD
Agency class:
Other
Source:
Rutgers, The State University of New Jersey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949021
