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.
Auf einen Blick
Worum geht es in dieser Studie?
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.
Wichtige Erkenntnisse
- 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.
Wer könnte berechtigt sein?
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.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Have I been diagnosed with advanced breast cancer that has spread?
- Is my breast cancer HR+ and HER2-?
- Has my cancer worsened after receiving hormone therapy for advanced cancer?
- Am I generally well enough to consider chemotherapy treatments?
- Bin ich 18 Jahre alt oder älter?
Was beinhaltet die Teilnahme?
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.
Potenzielle Risiken und Vorteile
Locations (288)
- Ironwood Physicians P.C. als Ironwood Krebs- und ForschungszentrenVerifizierte PostleitzahlChandler, Vereinigte Staaten
- Los Angeles Hematology Oncology Medical GroupVerifizierte PostleitzahlLos Angeles, Vereinigte Staaten
- Stanford Cancer InstituteVerifizierte PostleitzahlPalo Alto, Vereinigte Staaten
- University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer CenterVerifizierte PostleitzahlSan Francisco, Vereinigte Staaten
- Rocky Mountain Cancer Centers, LLPVerifizierte PostleitzahlLittleton, United States
- Yale-New Haven Hospital-Yale Cancer CenterVerifizierte PostleitzahlNew Haven, Vereinigte Staaten
- Investigational Drug Services, AdventHealth OrlandoVerifizierte PostleitzahlAltamonte Springs, United States
- Florida KrebsspezialistenVerifizierte PostleitzahlBrooksville, United States
- Florida Cancer SpecialistVerifizierte PostleitzahlLeesburg, United States
- Florida Cancer SpecialistVerifizierte PostleitzahlSt. Petersburg, Vereinigte Staaten
- Piedmont Cancer InstituteVerifizierte PostleitzahlAtlanta, Vereinigte Staaten
- Georgia Cancer Specialist - AnnexVerifizierte PostleitzahlAtlanta, Vereinigte Staaten
Häufige Fragen
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.
Werde ich meine Behandlung auswählen können?
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.
Wie lange wird die Studie dauern, wenn ich teilnehme?
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.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
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