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Active not recruitingPHASE3INTERVENTIONAL

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

This research study is comparing a new medication called Sacituzumab Govitecan with existing standard treatments for a type of advanced breast cancer. This cancer is known as Hormone Receptor-positive/HER2-negative metastatic breast cancer. The main goal is to find out if the new drug can help people live longer, and if it can stop the cancer from growing or spreading for a longer time, compared to current treatments like paclitaxel, nab-paclitaxel, or capecitabine. If you have advanced breast cancer that has already been treated with hormone therapy and your cancer has worsened, this study might be relevant to you.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Gilead Sciences
Enrolment target
654
Start
08 May 2023
Estimated completion
01 Apr 2028

What is this study about?

This study is about a type of advanced breast cancer known as Hormone Receptor-positive (HR+) and HER2-negative (HER2-) metastatic breast cancer. 'Metastatic' means the cancer has spread from where it started to other parts of the body. 'HR+' means the cancer cells have receptors that respond to hormones, and 'HER2-' means they don't have too much of a protein called HER2. These details help doctors decide the best way to treat the cancer.

At the moment, people with this type of cancer are often treated with hormone therapy. However, if the cancer continues to grow or spread even after hormone therapy, doctors then consider chemotherapy. This study wants to see if a new drug, called Sacituzumab Govitecan, can be a better option than the chemotherapy drugs currently used in this situation.

Sacituzumab Govitecan is a type of targeted therapy, which means it's designed to attack cancer cells more specifically. The researchers want to know if this new drug can help people live longer, and if it can keep the cancer from getting worse for a longer period of time, compared to established chemotherapy options like paclitaxel, nab-paclitaxel, or capecitabine. This study is important because it could lead to new and more effective treatments for people living with advanced breast cancer.

Key takeaways

  • This study compares a new drug to standard treatments for advanced breast cancer.
  • It's for HR+/HER2- metastatic breast cancer that has progressed after hormone therapy.
  • The new drug is called Sacituzumab Govitecan.
  • You might live longer or have your cancer controlled for longer with the new drug.
  • You won't choose your treatment; it's decided by chance.
  • Participation involves regular clinic visits for checks and treatment.

Who may be eligible?

To join this study, your doctor will need to check various things. You must have advanced breast cancer that is Hormone Receptor-positive (HR+) and HER2-negative (HER2-), and it should have spread to other parts of your body. Importantly, your cancer needs to have shown signs of getting worse, even after you've had at least two different hormone therapies for your advanced cancer. Or, if your cancer came back or worsened quickly after you started hormone therapy, you might also be able to join.

You also need to be well enough to receive chemotherapy treatments like capecitabine, nab-paclitaxel, or paclitaxel. The study will need a sample of your cancer tissue. If you have HIV, you can still participate if your HIV infection is well-controlled with medication. The medical team will carefully review all your medical details to see if this study is right for you.

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.

  1. Have I been diagnosed with advanced breast cancer that has spread?
  2. Is my breast cancer HR+ and HER2-?
  3. Has my cancer worsened after receiving hormone therapy for advanced cancer?
  4. Am I generally well enough to consider chemotherapy treatments?
  5. Am I 18 years old or older?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the new medicine, Sacituzumab Govitecan, or one of the standard chemotherapy treatments (paclitaxel, nab-paclitaxel, or capecitabine). You won't get to choose which one you receive; it will be decided randomly. You will have regular visits to the clinic for your treatment and to have your health checked. These visits will involve physical examinations, blood tests, and scans (like CT or MRI scans) to see how your cancer is responding to the treatment. The number of visits and the total length of your participation will depend on how you respond to the treatment and how long the drug continues to help you. The study team will explain everything in detail, including what to expect at each appointment and how long the study might last for you.

Potential risks and benefits

Potential benefits of joining this study include possibly receiving a new treatment that might be more effective than current standard options in controlling your cancer and improving your quality of life. However, as with all medical treatments, there are potential risks and side effects. These could vary depending on the treatment you receive, and the study team will discuss all known side effects with you, helping you understand what to expect. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (288)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
    Verified postcode
    Chandler, United States
  • Los Angeles Hematology Oncology Medical Group
    Verified postcode
    Los Angeles, United States
  • Stanford Cancer Institute
    Verified postcode
    Palo Alto, United States
  • University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
    Verified postcode
    San Francisco, United States
  • Rocky Mountain Cancer Centers, LLP
    Verified postcode
    Littleton, United States
  • Yale-New Haven Hospital-Yale Cancer Center
    Verified postcode
    New Haven, United States
  • Investigational Drug Services, AdventHealth Orlando
    Verified postcode
    Altamonte Springs, United States
  • Florida Cancer Specialists
    Verified postcode
    Brooksville, United States
  • Florida Cancer Specialist
    Verified postcode
    Leesburg, United States
  • Florida Cancer Specialist
    Verified postcode
    St. Petersburg, United States
  • Piedmont Cancer Institute
    Verified postcode
    Atlanta, United States
  • Georgia Cancer Specialist - Annex
    Verified postcode
    Atlanta, United States

Common questions

What type of breast cancer is this study for?

This study is for a specific type of advanced breast cancer that is Hormone Receptor-positive (HR+) and HER2-negative (HER2-) which has spread to other parts of the body.

What is Sacituzumab Govitecan?

It's a new investigational medication that the study is testing to see if it works better than current standard treatments for this type of breast cancer.

Will I get to choose my treatment?

No, if you join, you will be randomly assigned to receive either the new drug or one of the standard treatments. You won't get to choose.

How long will the study last if I join?

The length of your participation will depend on how your cancer responds to the treatment and how long the treatment continues to help you.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

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

Discussion

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