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Liposomal Doxorubicin + Carboplatin for Triple-negative Breast Cancer
Phase 2
Recruiting
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of the study up to 5 years
Awards & highlights
Study Summary
This trial will assess if combining 2 drugs is an effective & safe cancer treatment for early stage triple negative breast cancer patients, and explore if it can be used as a way to measure the effectiveness of the treatment.
Who is the study for?
This trial is for early-stage triple-negative breast cancer patients who've had surgery, with tumors under 2.5cm and limited nodal disease. They must understand the study, have not used anthracycline chemo before, and their major organs need to function well. People with advanced cancer, uncontrolled high blood pressure or heart issues, significant medical conditions or infections like HIV/Hepatitis B/C can't join.Check my eligibility
What is being tested?
The OCTANE trial tests a combination of liposomal doxorubicin and carboplatin in patients who've completed primary surgery for early-stage triple-negative breast cancer. It aims to see if this therapy reduces recurrence risk and will also explore changes in circulating tumor DNA as a potential treatment response biomarker.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems. Heart function may be affected due to these drugs' toxicity profile assessed by CTCAE v5.0.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is early stage, triple negative, with a tumor under 2.5cm and minimal to no spread to lymph nodes.
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My kidney function is within the required range.
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I am fully active or can carry out light work.
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I have finished my main surgery for cancer.
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I have never been treated with anthracycline-based chemotherapy.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My liver is functioning within the required limits.
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My cancer tests low for estrogen and progesterone receptors, and is not HER2 positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of the study up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of the study up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-Free Survival (DFS) Rate
Secondary outcome measures
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)
Other outcome measures
Changes in Circulating Tumor DNA (ctDNA) Levels. Monitoring ctDNA Dynamics Pre and Post Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Liposomal doxorubicin and CarboplatinExperimental Treatment1 Intervention
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):
Completed breast surgery and sentinel lymph node biopsy
Tumor size less than2.5 and NO/ N1mi disease
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,212 Total Patients Enrolled
16 Trials studying Breast Cancer
1,910 Patients Enrolled for Breast Cancer
Mridula George, MDLead Sponsor
2 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Breast Cancer
15 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is early stage, triple negative, with a tumor under 2.5cm and minimal to no spread to lymph nodes.My kidney function is within the required range.My liver is functioning within the required limits.I am fully active or can carry out light work.I don't have any health issues that would stop me from joining the study.My heart's pumping ability is good.I have finished my main surgery for cancer.I have never been treated with anthracycline-based chemotherapy.My blood tests show normal white blood cells, platelets, and hemoglobin levels.I have a serious wound, ulcer, or bone fracture that is not healing.I am willing and able to follow the trial's schedule and treatment plan.I have mild to severe numbness or tingling in my hands or feet.I have an ongoing liver condition.My cancer tests low for estrogen and progesterone receptors, and is not HER2 positive.I have had cancer before, but I've been cancer-free for the last 5 years.Your blood pressure is very high and not under control, with numbers higher than 190 over 100.My breast cancer is at stage III or IV.I do not have serious heart conditions or a recent heart attack.I do not have an active or uncontrolled infection with HIV, Hepatitis B, or Hepatitis C.I am allergic to one or more of the drugs used in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Liposomal doxorubicin and Carboplatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for this research endeavor?
"Data found on clinicaltrials.gov shows that despite first being posted in September 15th, 2023 and most recently updated July 13th, 2023; this trial is not currently accepting new members. However, there are 2429 additional medical studies looking for participants at the moment."
Answered by AI
How widespread is the availability of this clinical trial?
"This medical trial is currently taking place at 8 select sites, including RWJBarnabas Health Jersey City Medical Center in Jersey City, RWJBarnabas Health - Monmouth Medical Center Southern Campus in Lakewood and Rutgers Cancer Institute of New jersey in New Brunswick. There are 5 other similar centres where enrolment for the trial may take place."
Answered by AI
How reliable are Liposomal doxorubicin and Carboplatin treatments for individuals?
"Our team at Power assigned Liposomal doxorubicin and Carboplatin a safety rating of 2, since the Phase 2 trial only provides evidence regarding its security but not efficacy."
Answered by AI
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