Triple Negative Breast Cancer (TNBC)Phase 2NCT05949021
OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer
A Phase 2 study testing Combination of liposomal doxorubicin in people with Triple Negative Breast Cancer (TNBC), run by Mridula George, MD at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Combination of liposomal doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 7 Oct 2023to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
RWJBarnabas Health - Trinitas hospital and Comprehensive Center
Elizabeth, New Jersey, 08755
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
University Hospital-Newark
Newark, New Jersey, 07112
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
About this study
Official title: OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple Negative Breast Cancer
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.
Read more
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.
Read the 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.
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Being tested
- Combination of liposomal doxorubicin
- Keywords
- Liposomal doxorubicin, Carboplatin, Triple negative breast cancer (TNBC), Adjuvant therapy, Multicenter, Phase II clinical trial
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of liposomal doxorubicinDrug
Combination of liposomal doxorubicin 30 milligrams per square meter and carboplatin (area under the curve 5), administered every 4 weeks for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal doxorubicin and Carboplatin | Experimental | Combination of liposomal doxorubicin 30milligrams per square meter (mg/m2) and carboplatin area under the curve 5 (AUC 5), administered every four weeks for four cycles.
Participants with triple-negative breast cancer (TNBC):
1. Completed breast surgery and sentinel lymph node biopsy
2. Tumor size less than2.5 and NO/ N1mi disease Receives: Drug: Combination of liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) Rate
The disease-free survival (DFS) rate is used to evaluate the efficacy of liposomal doxorubicin and carboplatin in the adjuvant setting. It assesses the proportion of participants who remain free from disease recurrence or progression after receiving the combination treatment as an adjuvant therapy for their cancer.
DFS rate is calculated by dividing the number of participants who have not experienced disease recurrence or progression within a specified timeframe by the total number of participants enrolled in the clinical trial.
DFS Rate (%) = (Number of participants with no disease recurrence or progression / Total number of participants enrolled) × 100 A higher DFS rate indicates a greater efficacy of liposomal doxorubicin and carboplatin as an adjuvant treatment, suggesting their ability to delay or prevent disease recurrence or progression in participants. A higher DFS rate implies a better prognosis and improved disease control in the adjuvant setting.
Measured: From the start of the study up to 5 years
Secondary outcomes (1)
Safety and Toxicity Profile of the Study Treatment as measured by Adverse Events Rates and Common Terminology Criteria for Adverse Events version 5 (CTCAE v.5)
The outcome measure aims to characterize the safety and toxicity profile of the study treatment by assessing the occurrence and severity of adverse events (AEs) as measured using the CTCAE v.5). The CTCAE v.5 utilizes a standardized grading scale to assess the severity of adverse events. The scale consists of grades ranging from 1 to 5, with each grade corresponding to a specific level of severity. The grades are:
Grade 1 Mild Event is asymptomatic or mild, requiring minimal or no medical intervention.
Grade 2 Moderate Event minimal to moderate interference with daily activities, and some medical intervention.
Grade 3 Severe Event causes significant interference with daily activities, and medical intervention or treatment is required.
Grade 4 Life-threatening or disabling Event poses immediate risk to life or function, requiring urgent medical intervention or treatment.
Grade 5 Death Event results in death related to the adverse event.
Measured: From the start of the study up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start7 Oct 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mridula George, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mridula George, MD, Rutgers, The State University of New Jersey
- Investigators
- Mridula George, MD, Principal investigator, Cancer Institute of New Jersey Rutgers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949021
- Sponsor's protocol ID
- 042304
- Other IDs
- Pro2023001280
- Status last verified
- Nov 2025
- First submitted
- 6 Jul 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05949021
- Acronym / sponsor ID
- 042304
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Keywords
- Liposomal doxorubicin, Carboplatin, Triple negative breast cancer (TNBC), Adjuvant therapy, Multicenter, Phase II clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mridula George, MDUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposomal doxorubicin and Carboplatin | Experimental | Drug: Combination of liposomal doxorubicinCombination of liposomal doxorubicin 30milligrams per square meter (mg/m2) and carboplatin area under the curve 5 (AUC 5), administered every four weeks for four cycles. Participants with triple-negative breast cancer (TNBC): 1. Completed breast surgery and sentinel lymph node biopsy 2. Tumor size less than2.5 and NO/ N1mi disease |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of liposomal doxorubicinCombination of liposomal doxorubicin 30 milligrams per square meter and carboplatin (area under the curve 5), administered every 4 weeks for 4 cycles. | Drug | Liposomal doxorubicin and Carboplatin |
Primary outcome
Disease-Free Survival (DFS) Rate
Time frame: From the start of the study up to 5 years
The disease-free survival (DFS) rate is used to evaluate the efficacy of liposomal doxorubicin and carboplatin in the adjuvant setting. It assesses the proportion of participants who remain free from disease recurrence or progression after receiving the combination treatment as an adjuvant therapy for their cancer. DFS rate is calculated by dividing the number of participants who have not experienced disease recurrence or progression within a specified timeframe by the total number of participants enrolled in the clinical trial. DFS Rate (%) = (Number of participants with no disease recurrence or progression / Total number of participants enrolled) × 100 A higher DFS rate indicates a greater efficacy of liposomal doxorubicin and carboplatin as an adjuvant treatment, suggesting their ability to delay or prevent disease recurrence or progression in participants. A higher DFS rate implies a better prognosis and improved disease control in the adjuvant setting.
1 secondary outcome
Safety and Toxicity Profile of the Study Treatment as measured by Adverse Events Rates and Common Terminology Criteria for Adverse Events version 5 (CTCAE v.5)
Time frame: From the start of the study up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mridula George, MD principal investigator
Cancer Institute of New Jersey Rutgers
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of liposomal doxorubicin in people with Triple Negative Breast Cancer (TNBC), run by Mridula George, MD at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) Rate (time frame: From the start of the study up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.