Active not recruitingPHASE2INTERVENTIONAL

CFI-400945 in Patients With Advanced/Metastatic Breast Cancer

This study is looking into a new medication called CFI-400945 for women with advanced, metastatic breast cancer that has already spread. These patients have already received at least one course of chemotherapy. The study aims to see if CFI-400945 can help slow the growth of cancer cells or make tumours shrink. Scientists believe this new drug works by blocking a specific protein involved in cancer growth. Early tests in animals showed promise, and previous studies in a small number of patients suggest it's generally well-tolerated with few side effects. This trial is designed to find out if CFI-400945 offers a better treatment option than current standard approaches.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Canadian Cancer Trials Group

Enrolment target

Start

14 Feb 2019

Estimated completion

31 Dec 2026

Breast Cancer

What is this study about?

This study is investigating a new drug called CFI-400945 for women who have advanced breast cancer. This means the cancer has spread from where it started to other parts of the body, or it has come back after previous treatment. It's for patients who have already received at least one course of chemotherapy for their breast cancer.

The drug, CFI-400945, is designed to target a specific protein in cancer cells called Polo-like Kinase 4 (PLK4). This protein plays a role in how cancer cells grow. By blocking this protein, the drug might be able to slow down the growth of cancer or even cause cancer cells to die. So far, laboratory tests and studies in animals have shown that CFI-400945 can shrink tumours, and it has been studied in a small number of people and seemed to be tolerated well, with few side effects. This is a "Phase 2" study, which means researchers are trying to learn more about how well the drug works and any side effects it might have.

The main goal of this study is to see if CFI-400945 can offer a better way to treat advanced breast cancer than the treatments currently available. Researchers will carefully monitor patients to see if the drug helps to control their cancer and if it improves their overall health and quality of life. Participating in a study like this helps doctors learn more about new treatments, potentially leading to better options for future patients.

Key takeaways

This study tests a new drug (CFI-400945) for advanced breast cancer.
It's for women aged 18+ who have already had chemotherapy.
The drug aims to block a protein to slow cancer growth.
Early studies suggest the drug is well-tolerated.
Regular hospital visits, tests, and scans will track progress.
Participation helps scientists find new treatments for breast cancer.

Who may be eligible?

This study is specifically for women aged 18 or older who have been diagnosed with advanced breast cancer that has spread or returned. You must have already had at least one chemotherapy treatment for your cancer.

There are different groups within the study depending on the specific characteristics of your breast cancer cells. For example, some groups are for those whose cancer doesn't have certain hormone receptors (ER and PR) and a protein called HER2. Other groups are for those whose cancer does have these hormone receptors but is negative for HER2, and they will look at a specific protein called PTEN in the cancer cells.

To join, doctors will also need a sample of your tumour tissue from a previous biopsy or surgery. You will also need to be fit enough for the study, meaning you can generally carry out your daily activities without too much difficulty, and your doctors believe you have a life expectancy of at least 3 months.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Have you been diagnosed with advanced (metastatic or recurrent) breast cancer?
Have you already received at least one round of chemotherapy for your breast cancer?
Do you have a tumour tissue sample available from a past biopsy or surgery?
Are you generally well enough to manage daily activities without major difficulty?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new drug, CFI-400945. The exact schedule for taking the drug will be explained by the study team. You will have regular visits to the hospital for check-ups, blood tests, and scans (like X-rays or CT scans) to see how your body is responding to the treatment and whether the cancer is changing. These scans will be done regularly, usually within 21 days before joining and then throughout the study. You may also be asked to have additional tumour biopsies at specific times during the study, particularly if your cancer responds well, to help researchers understand more about the drug's effects. The study team will track any side effects you experience. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment that could help slow down your cancer or shrink your tumours, especially if standard treatments haven't been fully effective. However, as CFI-400945 is a new drug, there may be unknown side effects, although previous small studies have suggested it is generally well-tolerated. It's important to understand that there's no guarantee the drug will help you. You will have more hospital visits and tests than usual, which can be time-consuming. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

Juravinski Cancer Centre at Hamilton Health Sciences
Verified postcode
Hamilton, Canada
London Regional Cancer Program
Verified postcode
London, Canada
Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada
Odette Cancer Centre
Verified postcode
Toronto, Canada
University Health Network
Verified postcode
Toronto, Canada
Allan Blair Cancer Centre
Verified postcode
Regina, Canada

Common questions

What is advanced breast cancer?

Advanced breast cancer is when the cancer has spread from its original site to other parts of the body (metastatic) or has come back after previous treatment and cannot be cured by surgery.

What does 'Phase 2' in a clinical trial mean?

Phase 2 means researchers are testing the drug in a larger group of people to see how well it works, what the best dose is, and to continue monitoring for side effects.

Will I know if I'm getting the study drug or a placebo?

In this specific study, all participants will receive the active drug, CFI-400945. There is no placebo group.

What are 'measurable disease' and 'RECIST 1.1'?

This refers to the doctors being able to clearly measure the size of your tumours (measured in specific ways like on scans and physical exams) to track how the treatment is working.

Do I have to have a new biopsy?

Doctors will need a sample of your tumour tissue from a past procedure. New biopsies are encouraged at certain points but may not be strictly required for everyone to join.