A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
This research study is for people with advanced breast cancer that's HER2-positive and ER-positive (meaning it has specific characteristics). It's a Phase 3 trial, which means it’s a big step in testing new treatments. The main goal is to find out if adding a new drug, Giredestrant, to an established treatment called Phesgo, is more effective and safe than Phesgo on its own. Participants will first receive a combination of Phesgo and another chemotherapy drug (either Docetaxel or Paclitaxel). After this initial treatment, they will then be randomly assigned to receive either the Giredestrant plus Phesgo combination or Phesgo alone. The study wants to see if this new approach can help manage breast cancer better.
At a glance
What is this study about?
Imagine your doctor tells you your breast cancer is 'advanced' – this means it might have spread to other parts of your body or is locally advanced and can't be cured with surgery. It can be a very worrying time, and doctors are always looking for better ways to treat it. This study focuses on a specific type of advanced breast cancer that has two particular features: it's 'HER2-positive' and 'ER-positive'. These features help doctors choose the best treatments.
This trial is looking at a new medicine called Giredestrant. It's being tested alongside an existing treatment called Phesgo. Phesgo is a medicine that helps target HER2-positive cancers. The researchers want to see if adding Giredestrant to Phesgo can improve how well Phesgo works and if it's safe for patients. To do this, some people in the study will get the new combination, and others will get Phesgo on its own, so doctors can compare the results.
Before starting the main part of the study, all participants will receive an initial treatment. This involves Phesgo combined with another chemotherapy drug. After this initial phase, if your cancer hasn't progressed, you'll then move on to receive either the new combination treatment or Phesgo alone. This study is an important step in understanding if Giredestrant could offer a new, more effective treatment option for this type of advanced breast cancer.
Key takeaways
- This study is for people with specific types of advanced breast cancer (HER2-positive and ER-positive).
- It tests a new drug called Giredestrant alongside an existing treatment, Phesgo.
- The goal is to see if the new combination is more effective and safe.
- Participation involves initial treatment, then being randomly assigned to one of two groups.
- Close monitoring of your health and cancer response will be part of the study.
- You can withdraw from the study at any time.
Who may be eligible?
This study is open to adults aged 18 and over, both men and women, who have a specific type of advanced breast cancer. This means your cancer has been confirmed as HER2-positive and ER-positive, and it's either spread to other parts of your body (metastatic) or is locally advanced and can't be completely removed by surgery. You also need to be generally well enough to take part, with a good heart function and other body systems working properly.
Before you can join the main part of the study, you would first receive a standard initial treatment involving Phesgo and another chemotherapy. For you to continue in the study after this initial treatment, your cancer must not have gotten worse. Also, if you've already had hormone treatment for your advanced breast cancer, or if your cancer came back less than six months after your last non-hormonal treatment for earlier breast cancer, you might not be able to join.
It's also important that if you can get pregnant or father a child, you agree to use effective birth control or avoid sex during the study and for seven months afterwards, to prevent any risks to a pregnancy. The research team will carefully check all your medical information to make sure the study is a safe and suitable option 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 advanced breast cancer that's HER2-positive and ER-positive?
- Has your cancer not previously been treated with non-hormone therapy for advanced disease?
- Is your heart function good (LVEF of 50% or more)?
- Are you willing to use effective birth control during and after the study if you can become pregnant or father a child?
- Is your cancer stable or improved after initial treatment with Phesgo and chemotherapy?
What does participation involve?
If you join this study, you will first receive an initial treatment that combines Phesgo injections with either Docetaxel (4 sessions) or Paclitaxel (12 sessions). This initial phase lasts a few months. If your cancer hasn't worsened after this, you'll then be randomly assigned to one of two groups: one group will receive a combination of the new drug Giredestrant and Phesgo, while the other group will receive Phesgo alone. Both parts of the study involve regular clinic visits, blood tests, and scans to monitor your health and how your cancer is responding. The duration of treatment varies, and follow-up will continue even after treatment stops to track your progress and long-term health. The total duration of your participation will depend on how you respond to treatment and will be explained in detail by the study team.
Potential risks and benefits
Locations (206)
- Arizona Clinical Research Center, IncVerified postcodeTucson, United States
- Los Angeles Hematology Oncology Medical GroupVerified postcodeLos Angeles, United States
- Cancer Specialists of North FloridaVerified postcodeJacksonville, United States
- Maryland Oncology Hematology - AnnapolisVerified postcodeAnnapolis, United States
- St. Joseph Mercy HospitalVerified postcodeAnn Arbor, United States
- Henry Ford HospitalVerified postcodeDetroit, United States
- St. Joseph Mercy OaklandVerified postcodePontiac, United States
- Queens Hospital Cancer CenterVerified postcodeJamaica, United States
- Clinical Research AllianceVerified postcodeWestbury, United States
- West Cancer CenterVerified postcodeGermantown, United States
- CHRISTUS Spohn Cancer Center - ShorelineVerified postcodeCorpus Christi, United States
- Texas Oncology - DFWVerified postcodeDallas, United States
Common questions
What is HER2-positive and ER-positive breast cancer?
These are specific features of breast cancer cells. HER2-positive means the cancer cells have too much of a protein called HER2, which helps them grow. ER-positive means the cancer cells are affected by the hormone oestrogen. Knowing these helps doctors choose the right treatments.
What is Phesgo?
Phesgo is a combination of two medicines (pertuzumab and trastuzumab) that target the HER2 protein on cancer cells. It also contains an enzyme that helps the medicines get into the body more easily through an injection under the skin.
What is Giredestrant?
Giredestrant is a new type of drug that aims to block the effects of oestrogen on cancer cells. This is important for ER-positive breast cancers that rely on oestrogen to grow.
What does 'randomized' mean?
Randomized means that participants are put into treatment groups by chance, like flipping a coin. This helps make sure the groups are similar, so we can fairly compare the treatments.
What is a Phase 3 study?
A Phase 3 study is a large study that compares a new treatment with an existing standard treatment. It's a key step to see if a new treatment is safe and effective enough to be approved for wider use.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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