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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

Must not have

Presence of a serious non-healing wound, ulcer, or bone fracture

Pre-existing sensory neuropathy greater than grade 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the study up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious wound, ulcer, or bone fracture that is not healing.

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I have mild to severe numbness or tingling in my hands or feet.

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I have an ongoing liver condition.

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My breast cancer is at stage III or IV.

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I do not have serious heart conditions or a recent heart attack.

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I do not have an active or uncontrolled infection with HIV, Hepatitis B, or Hepatitis C.

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I am allergic to one or more of the drugs used in this study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the study up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-Free Survival (DFS) Rate

Secondary study objectives

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 study objectives

Changes in Circulating Tumor DNA (ctDNA) Levels. Monitoring ctDNA Dynamics Pre and Post Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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): 1. Completed breast surgery and sentinel lymph node biopsy 2. Tumor size less than2.5 and NO/ N1mi disease

0 / 15Eligibility criteria met