Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
This research study is for people who have been diagnosed with triple-negative breast cancer that hasn't completely gone away after their initial treatment and surgery. Doctors want to find out if a new combination of medicines, called sacituzumab govitecan-hziy (SG) and pembrolizumab, works better and is safer than standard treatments. These standard treatments could include pembrolizumab alone or pembrolizumab with capecitabine. The study aims to see if the new combination can help prevent the cancer from coming back or spreading in the future. It's a Phase 3 study, meaning it's comparing a new treatment to existing ones to confirm its benefits and look at any side effects.
At a glance
What is this study about?
This study, called ASCENT-05, is focusing on a type of breast cancer known as triple-negative breast cancer (TNBC). TNBC is a more aggressive form of breast cancer that doesn't have certain receptors (like oestrogen, progesterone, or HER2) that some other breast cancers do. This means it doesn't respond to hormone therapy or HER2-targeted drugs.
The study is for people who have already had initial treatment (like chemotherapy before surgery, known as neoadjuvant therapy) and then surgery, but still have some cancer cells left. The main goal is to test if a new combination of drugs, called sacituzumab govitecan-hziy (often shortened to SG) and pembrolizumab, is more effective and safer than current standard treatments. Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer, and SG is a targeted drug that delivers chemotherapy directly to cancer cells.
Participants in the study will either receive this new combination or a standard treatment chosen by their doctor, which might include pembrolizumab on its own or pembrolizumab with another chemotherapy drug called capecitabine. By comparing these treatments, researchers hope to find better ways to treat TNBC after surgery and improve patient outcomes. This is a crucial step in developing new medicines.
Key takeaways
- New study for triple-negative breast cancer (TNBC) after surgery.
- Compares new drug combination (SG + Pembrolizumab) to standard treatments.
- Aims for better effectiveness and safety for preventing cancer return.
- Phase 3 study, meaning it's a key step for new treatment discovery.
- Open to patients with TNBC that remains after initial treatment.
- Doctors hope to find improved ways to treat this aggressive cancer.
Who may be eligible?
To join this study, you need to be at least 18 years old and have triple-negative breast cancer that was found to still be present in your breast or lymph nodes after your initial treatment and surgery. Your doctor would have confirmed that your cancer meets the specific criteria for "triple-negative." You must have recovered well from your surgery, and any radiotherapy required should have been completed and recovered from.
There are also some things that might mean you can't join. For example, if your cancer has already spread to other parts of your body (Stage IV), or if you've already had certain types of treatments for breast cancer, you wouldn't be able to take part. Also, if you have certain heart conditions or known genetic mutations like BRCA, you might not be eligible. The study team will check your full medical history to confirm 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.
- Are you 18 years old or older?
- Do you have triple-negative breast cancer that remained after your initial treatment and surgery?
- Have you recovered well from your surgery and any radiotherapy?
- Is your cancer not spread to other parts of your body (no Stage IV disease)?
- Have you not had previous specific treatments that would exclude you?
What does participation involve?
If you join this study, you'll be assigned to receive either the new drug combination (sacituzumab govitecan-hziy and pembrolizumab) or one of the standard treatments (pembrolizumab, or pembrolizumab with capecitabine). The specific visits and assessments will vary depending on which group you are in, but it will involve regular hospital visits for drug administration, blood tests, and check-ups to monitor your health and how the treatment is working. Generally, you can expect to have scans, physical examinations, and answer questions about your well-being. The study will involve ongoing treatment and follow-up for a period, which your study doctor will explain in detail.
Potential risks and benefits
Locations (339)
- Alabama OncologyVerified postcodeBirmingham, United States· Recruiting
- Clearview Cancer InstituteVerified postcodeHuntsville, United States· Recruiting
- Palo Verde Hematology OncologyVerified postcodeGlendale, United States· Recruiting
- Mayo Clinic HospitalVerified postcodePhoenix, United States· Withdrawn
- Arizona Oncology AssociatesVerified postcodePrescott Valley, United States· Withdrawn
- Alta Bates Summit Medical CenterVerified postcodeBerkeley, United States· Recruiting
- Community Cancer InstituteVerified postcodeClovis, United States· Withdrawn
- PIH Health Whittier HospitalVerified postcodeDowney, United States· Recruiting
- Compassionate Cancer Care Medical Group - IncVerified postcodeFountain Valley, United States· Recruiting
- Los Angeles Cancer NetworkVerified postcodeLos Angeles, United States· Recruiting
- USC Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States· Withdrawn
- Cedars-Sinai Cancer at Beverly HillsVerified postcodeLos Angeles, United States· Recruiting
Common questions
What does 'Triple Negative Breast Cancer' mean?
It's a type of breast cancer that doesn't have three specific features (receptors for oestrogen, progesterone, and HER2 protein). This means it doesn't respond to some common breast cancer treatments and requires different approaches.
What are 'sacituzumab govitecan-hziy' and 'pembrolizumab'?
Sacituzumab govitecan-hziy is a targeted chemotherapy drug that delivers medicine directly to cancer cells. Pembrolizumab is an immunotherapy that works by helping your body's own immune system fight the cancer.
Why is this study important?
It aims to find better treatments for triple-negative breast cancer that remains after initial therapy and surgery, hoping to improve outcomes for patients and prevent the cancer from coming back.
Will I know which treatment I'm receiving?
In some studies, you might not know if you're getting the experimental drug or standard treatment, this is called 'blinding'. The study team will explain how this works for this particular trial.
What if I decide to stop participating?
You are free to leave the study at any time, for any reason, without it affecting your usual medical care. Just let the study team know your decision.
How to find out more
Gilead Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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