Active not recruitingPHASE3INTERVENTIONAL

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

This study is for adults with a type of breast cancer known as triple-negative breast cancer (TNBC) that is advanced, cannot be removed by surgery, or has spread to other parts of the body. Doctors are testing a new medicine called Sacituzumab Govitecan-hziy. This drug will be compared to other standard chemotherapy treatments that doctors usually choose for patients. The main goal is to find out if the new drug can stop the cancer from getting worse for longer than the standard treatments. The study is particularly looking at patients whose cancer cells don't have a specific marker called PD-L1, or those who have had a certain type of immunotherapy in the past.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Gilead Sciences

Enrolment target

623

Start

20 Jul 2022

Estimated completion

01 Jul 2028

Triple Negative Breast Cancer PD-L1 Negative

What is this study about?

This study is investigating a new treatment for triple-negative breast cancer (TNBC), which is a more aggressive type of breast cancer that doesn't respond to some common breast cancer therapies. This particular study is for people whose TNBC has either spread (metastatic) or is advanced and cannot be removed with surgery. If you have this type of cancer, your doctor might already be offering you treatment choices.

The main aim of this study is to see how well a new drug, called Sacituzumab Govitecan-hziy, works compared to standard chemotherapy treatments already used by doctors. The researchers want to know if the new drug is better at stopping the cancer from growing or spreading. They will be particularly interested in patients whose cancer cells don't show a specific marker called PD-L1, or those who have already received a certain type of anti-cancer treatment (immunotherapy) for their early-stage breast cancer.

By comparing these treatments, the doctors hope to find a more effective way to manage advanced triple-negative breast cancer. It's an important step in finding better care for people living with this condition.

Key takeaways

This study is for advanced, inoperable, or metastatic triple-negative breast cancer.
It compares a new experimental drug to standard chemotherapy options.
The main goal is to see which treatment stops cancer growth for longer.
Patients with 'PD-L1 negative' tumours are mostly included.
You'll receive close medical monitoring if you participate.

Who may be eligible?

To join this study, people need to be at least 18 years old and have triple-negative breast cancer that has either spread or is advanced and can't be removed by surgery. Your cancer cells must also be tested to confirm they are "PD-L1 negative." If you've had a type of immunotherapy called an "anti-PD-(L)1 inhibitor" for earlier breast cancer, you might also be able to join even if your cancer is PD-L1 positive.

You'd need to be generally well enough to take part and have your organs working properly. If you've had breast cancer treatment before, you'd need to have finished it at least 6 months ago (except for hormone therapy). You can't have received other anti-cancer treatments recently (within the last 6 months) or radiation within 2 weeks. Also, you can't be pregnant, breastfeeding, or taking part in another study with a new drug or device.

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 or older?
Do you have triple-negative breast cancer that has spread or can't be operated on?
Has your doctor confirmed your cancer cells are 'PD-L1 negative'?
Have you not had systemic cancer treatment in the last 6 months (except hormone therapy)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

The detailed information on what taking part involves is not fully explained in this summary, but typically, studies like this often involve regular hospital visits, especially in the beginning, for check-ups, blood tests, scans (like CT or MRI), and to receive your study medication. You'll be assigned to receive either the new drug (Sacituzumab Govitecan-hziy) or one of the standard chemotherapy treatments (Paclitaxel, nab-Paclitaxel, Gemcitabine, or Carboplatin). Doctors will monitor you closely for any side effects and to see how the treatment is working. Your participation would continue as long as the treatment is helping and you're not experiencing severe side effects, followed by a period of follow-up. The total duration of participation can vary greatly depending on the individual's response to treatment.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as receiving a new treatment that isn't widely available yet, which could be more effective. You'll also receive close medical attention and monitoring. However, there are also potential risks; the new drug might have side effects that aren't fully known, or it might not work as well as expected. Standard chemotherapy treatments also have known side effects. It's important to understand that you can choose to leave the study at any time, for any reason, if you decide it's not right for you.

Locations (363)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd
Verified postcode
Tucson, United States
Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.
Verified postcode
Tucson, United States
Arizona Oncology Associates, PC-Hope
Verified postcode
Tucson, United States
Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road
Verified postcode
Tucson, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200
Verified postcode
Burbank, United States
University of California San Diego Moores Cancer
Verified postcode
La Jolla, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200
Verified postcode
Laguna Hills, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240
Verified postcode
San Luis Obispo, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600
Verified postcode
Santa Monica, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304
Verified postcode
Santa Monica, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center
Verified postcode
Santa Monica, United States
Torrance Memorial Physician Network - Cancer Care
Verified postcode
Torrance, United States

Common questions

What is triple-negative breast cancer?

It's a type of breast cancer that doesn't have certain features (receptors) that other breast cancers often have, making it harder to treat with some common medicines.

What does 'locally advanced inoperable or metastatic' mean?

It means the cancer is advanced in the area where it started and can't be removed with surgery, or it has spread to other parts of the body.

What is Sacituzumab Govitecan-hziy?

It's a new experimental drug being tested to see if it can help treat this type of breast cancer more effectively.

What does 'PD-L1 negative' mean for my cancer cells?

It refers to a test result on your cancer cells. If they are 'PD-L1 negative,' it means they don't produce a specific protein that some newer immunotherapy drugs target.

Will I get the new drug or a standard treatment?

In this study, you would be randomly assigned to receive either the new drug or one of the standard chemotherapy treatments that doctors typically use.