Study on Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer
Sponsor: Mridula George, MD
ClinicalTrials ID:NCT05949021
This clinical trial is testing a combination of two drugs, liposomal doxorubicin and carboplatin, to see if they can help prevent the return of early-stage triple-negative breast cancer after surgery. The study also looks at the safety of these drugs and explores how they affect cancer-related DNA in the blood.
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Program Overview
The purpose of this study is to find out if using liposomal doxorubicin and carboplatin after surgery can reduce the risk of cancer coming back in patients with early-stage triple-negative breast cancer (TNBC). The study will also check how safe these drugs are and if they cause any side effects. Additionally, researchers will explore changes in cancer-related DNA in the blood to see if it can be used to track treatment response and disease progression. By achieving these goals, the study aims to improve understanding of the benefits and risks of this drug combination for early-stage TNBC, potentially leading to better treatment outcomes.
Description
Triple-negative breast cancer (TNBC) is a type of breast cancer that does not have certain receptors, making it more challenging to treat and more likely to return. The usual treatment involves chemotherapy, which can have significant side effects. This study is testing a new combination of drugs, liposomal doxorubicin and carboplatin, to see if they can be a better option for patients with early-stage TNBC after surgery.
The main goal is to see if these drugs can help prevent the cancer from coming back. Researchers will measure how long patients remain free of cancer after treatment. They will also look at the safety of the drugs by monitoring any side effects that occur.
The study will also explore how these drugs affect cancer-related DNA in the blood, which could help in understanding how well the treatment is working and if the cancer is progressing.
This is a phase II clinical trial, meaning it is focused on evaluating the effectiveness and safety of the treatment. Patients who have had surgery to remove their primary tumor will receive the drug combination as part of their follow-up care. The study will involve regular check-ups and tests to monitor the patients' health and the treatment's impact.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with early-stage triple-negative breast cancer (TNBC) with a tumor size less than 2.5 cm and limited lymph node involvement.
- Completed surgery to remove the primary tumor.
- Low levels of certain receptors (estrogen, progesterone, and HER2) in the cancer cells.
- No evidence of other cancers in the last five years.
- Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Heart function within normal limits.
- No previous treatment with certain chemotherapy drugs (anthracyclines).
- Adequate blood cell counts and organ function, including:
- Neutrophil count of at least 1500/uL.
- Platelet count of at least 100,000/uL.
- Hemoglobin level of at least 9.0 g/dL.
- Liver and kidney function within specified limits.
- Ability to understand the study and provide informed consent.
- Willingness to attend scheduled visits and follow the treatment plan.
Exclusion Criteria
- Have stage III or IV breast cancer.
- Have uncontrolled high blood pressure.
- Have active liver disease.
- Have any condition that poses a high risk if participating in the study.
- Have significant nerve damage.
- Have serious heart conditions or recent heart attack.
- Have serious non-healing wounds or fractures.
- Have uncontrolled infections like HIV, Hepatitis B, or Hepatitis C.
- Have allergies to the study drugs.
- Have any significant medical or psychiatric conditions that would prevent participation.
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