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Study on Breast Cancer Treatment with Carboplatin for Patients in Neoadjuvant and Metastatic Stages

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on improving treatment for breast cancer, specifically in cases where the cancer is either in an early stage and being treated before surgery (neoadjuvant) or has spread to other parts of the body (metastatic). The study will use a medication called Carboplatin, which is given as a solution through an intravenous infusion. This means the medicine is delivered directly into the bloodstream through a vein. The purpose of the study is to understand how the genetic makeup of the cancer changes over time and how these changes can help in selecting the best treatment options.

Participants in the study will have samples of their tumors taken at different times: before starting treatment, during treatment if possible, and after the treatment period. These samples will be analyzed to look at the DNA of the cancer cells, which includes studying the entire genetic material of the cells. This analysis will help researchers understand the genetic characteristics of the tumors and how they change with treatment. The study will also look at other factors, such as changes in the levels of certain proteins and metabolites, which are small molecules involved in metabolism, in the body over time.

Additionally, the study will examine how the treatment affects circulating tumor DNA and cells in the blood, which can provide information about how the cancer is responding to the treatment. Researchers will also assess the levels of fatigue experienced by participants, as well as factors that might predict long-term fatigue. The study aims to provide insights that could lead to more personalized and effective treatment strategies for breast cancer patients in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as the type of breast cancer, tumor size, and overall health status.
The study focuses on individuals with HER2-negative breast adenocarcinoma, ensuring adequate blood, liver, and kidney function.
Step 2
Initial assessment
An initial assessment involves collecting tumor samples for DNA analysis. This helps in understanding the genetic characteristics of the tumor.
The analysis includes whole genome sequencing to evaluate the tumor's genomic state.
Step 3
Treatment administration
The treatment involves the administration of carboplatin, a chemotherapy drug, through an intravenous infusion.
The dosage is 10 mg/mL, and the frequency and duration of administration are determined by the study protocol.
Step 4
Ongoing monitoring
Throughout the treatment period, regular monitoring of the tumor's response is conducted.
This includes further DNA analyses to observe any changes in the tumor's genetic makeup.
Step 5
Post-treatment evaluation
After the treatment period, additional tumor samples are collected to assess the genomic changes.
The study aims to understand the overall change in mRNA and protein expression, as well as metabolite distribution.
Step 6
Final analysis
The final analysis includes evaluating the genomic tumor architecture and tumor cell heterogeneity.
The study also examines treatment-induced changes in circulating tumor DNA and cells in the blood.

Who can join the trial?

14 criteria

The patient must have **breast cancer** that is confirmed by a test called **histology** or **cytology**. This means the cancer is checked under a microscope.
The cancer must be **HER2-negative**. HER2 is a protein that can affect the growth of cancer cells.
The patient can be a man or a woman.
The cancer must be **measurable** by a scan and larger than 20 mm.
The **Ki67 labeling index** must be 20% or higher for certain tumor sizes. This index measures how fast cancer cells are growing.
The patient must have a **WHO performance status** of 2 or less. This is a scale that measures how well a person can perform daily activities.
The patient must have **adequate blood function**, meaning:
- Enough **neutrophils**, a type of white blood cell, with a count of at least 1.0 x 10⁹/L.
- Enough **platelets**, which help with blood clotting, with a count of at least 100 x 10⁹/L.
- Enough **hemoglobin**, which carries oxygen in the blood, with a level of at least 10 g/dL. Blood transfusions can be used to reach this level if needed.
- The patient must have **adequate liver function**, meaning:
  - **Total bilirubin** must be less than 1.5 times the upper limit of normal. Bilirubin is a substance made by the liver.
  - **AST** and **ALT**, which are liver enzymes, must be less than 2.5 times the upper limit of normal for one group of patients, and less than 5 times for another group.
  - The patient must have **adequate kidney function**, meaning:
    
    **Serum creatinine** must be 1.25 times the upper limit of normal or less. Creatinine is a waste product filtered by the kidneys.
    If measured, **creatinine clearance** should be within normal reference values. This measures how well the kidneys are working.
    The patient must be within certain age ranges, which are typically adults.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with breast cancer cannot participate.
Individuals who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Both males and females can participate, so gender is not a reason for exclusion.
Individuals who are part of a vulnerable population, such as those who cannot give consent or are at higher risk, are not automatically excluded unless specified.

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Verified sites

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Oslo Universitetssykehus HF
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Oslo, Norway

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Investigated drugs

I-BCT-1 is an investigational treatment being studied for its potential to improve breast cancer therapy. It is being tested in both the neoadjuvant (before surgery) and metastatic (advanced cancer) settings. The trial aims to understand how this treatment can be optimally selected based on the biological characteristics of the tumor. The study involves analyzing tumor samples to observe genetic changes over time, which may help in tailoring the treatment to individual patients' needs.

Carboplatin

What is already known about the treatment

Improved Breast Cancer Therapy (I-BCT-1) – This medication is currently being studied in a phase 2 clinical trial for its effectiveness in treating breast cancer, particularly in the neoadjuvant and metastatic settings. It is administered as part of a treatment regimen that is selected based on the biological characteristics of the tumor. The main therapeutic indication is breast cancer, and the trial aims to understand the genetic changes in tumors over time. The mechanism of action involves analyzing the genomic state of the tumor, including DNA and methylation changes, to tailor the treatment. This medication falls under the pharmacological classification of targeted cancer therapies, focusing on the genetic profile of the cancer cells.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump or seen on an X-ray. It typically begins in the cells of the milk-producing ducts or the glandular tissue called lobules. As the cancer progresses, it can invade nearby tissues and spread to other parts of the body through the lymphatic system or bloodstream. The progression of breast cancer can vary greatly, with some tumors growing slowly and others developing more rapidly. Changes in the tumor's genetic makeup can occur over time, influencing its behavior and response to treatment. Understanding these genetic changes is crucial for developing targeted therapies and managing the disease effectively.