Not yet recruitingPHASE2INTERVENTIONAL

First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.

This research study is investigating a new drug called Sacituzumab Govitecan (SG) for adults battling advanced triple-negative breast cancer. This is for patients who haven't yet received treatment for their advanced cancer. The main goal is to find out if SG can effectively slow down the cancer's progression when used as a first treatment. Researchers also want to learn if the drug works differently depending on specific characteristics of the cancer, such as whether it has something called homologous recombination deficiency (HRD) or not. By understanding this, doctors hope to better tailor treatments in the future. Participants will receive the drug in hospital and have regular check-ups.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Nathalie Levasseur

Enrolment target

Start

01 Dec 2025

Estimated completion

01 Mar 2028

Advanced Triple Negative Breast Cancer Breast Cancer Metastatic Breast Cancer

What is this study about?

This study is focusing on a type of breast cancer called triple-negative breast cancer, specifically when it's advanced. Advanced means the cancer has spread from where it started. Triple-negative breast cancer can be more challenging to treat because it doesn't respond to some common hormone or HER2-targeted therapies. This study is testing a new drug called Sacituzumab Govitecan (SG) as a 'first-line' treatment, meaning it's given to patients who haven't had other treatments for their advanced cancer yet. The main aim is to see if SG can help slow down the spread or growth of the cancer.

The researchers are also interested in understanding if SG works better for certain types of triple-negative breast cancer. They're looking closely at something called 'homologous recombination deficiency' (HRD). This is a feature of some cancers that might affect how they respond to specific treatments. By comparing how SG works in people with and without HRD, doctors hope to learn more about who might benefit most from this drug in the future.

This is a Phase 2 study, which means it's one of the earlier stages of drug testing. It's designed to gather more information about how well SG works and its safety in this specific group of patients. The findings from this study will help decide if SG should be tested in larger studies to potentially become a standard treatment option.

Key takeaways

This study is for adults with advanced triple-negative breast cancer.
It's testing a new drug called Sacituzumab Govitecan (SG) as a first treatment.
The main goal is to see if SG can slow down cancer progression.
Researchers also want to know if SG works better for specific cancer types (HRD vs. non-HRD).
Participation involves regular clinic visits for treatment and follow-up.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and willing to give your informed consent, meaning you understand the study and agree to take part. You must have advanced triple-negative breast cancer that cannot be cured by surgery or radiotherapy, and you shouldn't have received any previous treatment for your advanced cancer.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting the study and agree to use reliable birth control methods throughout the study and for six months after your last dose of the study drug. Women who are postmenopausal (no periods for over a year, or meet other specific conditions) can also join.

Your cancer must be confirmed as triple-negative based on recent tests. The study team will review all your medical information to make sure you meet these and other specific health requirements to join.

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 18 years old or older?
Do you have advanced triple-negative breast cancer that hasn't been treated yet?
Are you willing to use effective birth control if you could become pregnant?
Do you understand what being in a study involves and agree to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the drug Sacituzumab Govitecan (SG). This drug is given on day 1 and day 8 of a 21-day cycle. You will continue to have these 21-day cycles until your cancer starts to progress or if you decide to stop taking part in the study. This means you will visit the clinic for your treatments twice every three weeks.

Throughout the study, you'll have regular hospital visits for treatments and check-ups to see how you're responding to the drug and if you're experiencing any side effects. After you stop receiving the study drug, there will be a long-term follow-up period where you'll have check-ins every 12 weeks. These follow-ups might be over the phone or in person at the clinic. The total duration of your involvement in the study will depend on how your cancer responds to treatment and how long the follow-up period lasts.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. The main potential benefit for you could be access to a new drug, Sacituzumab Govitecan, which might help slow down your advanced triple-negative breast cancer. However, there's no guarantee that the drug will work for everyone, and it might not improve your condition. Like all medications, SG can have side effects, which the study team will monitor closely. You will be given detailed information about these possible risks before you agree to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

BC Cancer - Vancouver Center
Verified postcode
Vancouver, Canada

Common questions

What is 'triple-negative breast cancer'?

It's a type of breast cancer that doesn't have the three most common 'targets' for treatment (estrogen receptors, progesterone receptors, and HER2 protein). This means it responds differently to certain standard therapies.

What does 'advanced' breast cancer mean?

It means the cancer has spread beyond the breast and nearby lymph nodes to other parts of the body, or it has come back in an area that can't be removed with surgery.

What is Sacituzumab Govitecan (SG)?

It's a drug aimed at treating certain cancers. This study explores its use for advanced triple-negative breast cancer.

What is a 'first-line' treatment?

It means this is the first treatment someone receives for their advanced cancer, before trying other medications for it.

Will I have to pay to be in this study?

No, you will not have to pay for the study drug or study-related clinic visits.

How to find out more

Dr. Nathalie LeVasseur, MD

nathalie.levasseur@bccancer.bc.ca 604-877-6000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.