A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
This research study is investigating new treatment options for a specific type of advanced breast cancer. This cancer is known as 'oestrogen receptor-positive (ER+)' and 'HER2-negative (HER2-)'. The study is looking at a new drug, GDC-4198. It will first check the safety of GDC-4198 by itself and then combined with another drug called giredestrant. Later, the study will compare how well the GDC-4198 and giredestrant combination works, and how safe it is, against a different combination of abemaciclib and giredestrant. The main goal is to find out if these new treatments are safe and effective for people whose breast cancer has spread or is advanced, especially after previous treatments have stopped working. It's happening in two stages, focusing first on safety and then comparing effectiveness.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is for people in the UK living with a type of breast cancer that doctors call 'locally advanced' or 'metastatic ER+, HER2- breast cancer'. This means the cancer has spread beyond the original site or is at an advanced stage, and it has certain characteristics related to its hormones (oestrogen receptor-positive) and a protein called HER2 (HER2-negative).
The main purpose of this research is to explore new ways to treat this specific kind of breast cancer. We're looking at a new drug called GDC-4198. The study wants to see how safe this new drug is, both when used on its own and when combined with another medicine called giredestrant. After learning more about the safety, the study will then compare how well this new combination (GDC-4198 + giredestrant) works against a different treatment combination (abemaciclib + giredestrant). This comparison will help doctors understand which treatment might be more effective in shrinking tumours or slowing down the cancer's growth.
The study has two main parts. The first part (called Phase Ib) is mainly focused on checking the safety of GDC-4198 and how the body handles it. The second part (Phase II) will then actively compare the new treatment combination with the existing one, looking at both how well they work and their side effects. Ultimately, this research aims to find better treatments for people with this type of advanced breast cancer when previous treatments, like particular hormone therapies and CDK4/6 inhibitors, are no longer working.
النقاط الرئيسية
- A study for advanced ER+ HER2- breast cancer that has progressed after prior treatments.
- Investigating a new drug, GDC-4198, alone or in combination with giredestrant.
- Comparing these new treatments against abemaciclib plus giredestrant.
- Focuses on both the safety and effectiveness of the treatments.
- Designed for people whose cancer has spread or is advanced.
من قد يكون مؤهلاً؟
To be considered for this study, you would need to have breast cancer that doctors have confirmed as locally advanced or metastatic, and it must be 'oestrogen receptor-positive (ER+)' and 'HER2-negative (HER2-)'. A key point is that your cancer must have continued to grow or spread even after you've had treatment with specific types of medicines for advanced cancer, including certain hormone therapies and a type of drug called CDK4/6 inhibitors.
You should also be generally well, able to perform your daily activities, and doctors expect you to live for at least six more months. They'll also check if your cancer can be measured or evaluated by scans.
There are also reasons why you might not be able to join. For example, if your cancer symptoms are very severe and doctors believe you need urgent chemotherapy, or if you've already had many different lines of treatment for your advanced breast cancer. Also, certain stomach or gut problems, other recent cancers (within the last three years, unless it was a very minor type), or allergies to the study drugs would prevent you from taking part.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Do you have confirmed locally advanced or metastatic breast cancer?
- Is your breast cancer 'oestrogen receptor-positive (ER+)' and 'HER2-negative (HER2-)'?
- Has your cancer progressed despite previous treatments for advanced disease, including certain hormone therapies and CDK4/6 inhibitors?
- هل أنت بصحة جيدة بشكل عام وقادر على القيام بمعظم الأنشطة اليومية؟
- Have you not had more than one previous line of therapy for your advanced breast cancer?
- Have you not received chemotherapy for your metastatic breast cancer before?
ماذا يتضمن المشاركة؟
If you decide to take part in this study, you'll be given either GDC-4198 by itself, or GDC-4198 with giredestrant, or abemaciclib with giredestrant. You'll have regular visits to the hospital for check-ups, which will include blood tests, physical examinations, and scans to see how the treatment is working. The study team will explain exactly what your schedule will involve, including how often you'll need to visit and for how long.
You'll be taking study medication, which will be provided to you. The doctors and nurses will monitor you closely for any side effects and to check your general health. After you finish taking the study treatment, there will be a follow-up period where the team will continue to check on your health and well-being. The total length of your participation will depend on how you respond to the treatment and the phase of the study you are in, but the team will give you a clear idea of the expected duration during the consent process.
المخاطر والفوائد المحتملة
المواقع (39)
- City of Hopeالرمز البريدي المؤكددوارتي، الولايات المتحدة· التوظيف
- City of Hope - Orange County Lennar Foundation Cancer Centerالرمز البريدي المؤكدإرفاين، الولايات المتحدة· التوظيف
- مركز مورس للسرطان بجامعة كاليفورنيا في سان دييغوالرمز البريدي المؤكدلا جولا، الولايات المتحدة· التوظيف
- UCSF Helen Diller Family CCCالرمز البريدي المؤكدسان فرانسيسكو، الولايات المتحدة· التوظيف
- مركز موفيت للسرطانالرمز البريدي المؤكدتامبا، الولايات المتحدة· التوظيف
- معهد وينشيب للسرطان بجامعة إيموريالرمز البريدي المؤكدأتلانتا، الولايات المتحدة· التوظيف
- City of Hope® Cancer Center Chicagoالرمز البريدي المؤكدصهيون، الولايات المتحدة· التوظيف
- Barbara Ann Karmanos Cancer Instituteالرمز البريدي المؤكدديترويت، الولايات المتحدة· التوظيف
- Washington University Siteman Cancer Centerالرمز البريدي المؤكدسانت لويس، الولايات المتحدة· التوظيف
- معهد روتجرز للسرطان في نيو جيرسيالرمز البريدي المؤكدنيو برونزويك، الولايات المتحدة· التوظيف
- New York Cancer & Blood Specialistsالرمز البريدي المؤكدEast Patchogue, United States· التوظيف
- University of Pennsylvania - Abramson Cancer Centerالرمز البريدي المؤكدفيلادلفيا، الولايات المتحدة· التوظيف
أسئلة شائعة
What type of breast cancer is this study for?
This study is for locally advanced or metastatic breast cancer that is 'oestrogen receptor-positive (ER+)' and 'HER2-negative (HER2-)'. It's for when your cancer has continued to grow after previous treatments.
ما هي الأدوية التي يتم اختبارها؟
The study is testing a new drug called GDC-4198, alone or with giredestrant, and comparing it to a combination of abemaciclib and giredestrant.
Why are they doing this study?
The main goal is to find out if these new treatments are safe and effective in treating this specific type of advanced breast cancer, especially when other treatments haven't worked well enough.
هل سأحصل بالتأكيد على الدواء الجديد؟
You might get GDC-4198 by itself, or combined with giredestrant, or you might get abemaciclib with giredestrant. It's a randomised study, meaning you won't choose which treatment you receive.
هل يمكنني التوقف عن المشاركة في الدراسة إذا غيرت رأيي؟
نعم، يمكنك الانسحاب من الدراسة في أي وقت ولأي سبب دون أن يؤثر ذلك على رعايتك الطبية.
كيفية معرفة المزيد
Reference Study ID Number: GO46021 https://forpatients.roche.com/
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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