All studies
RecruitingPHASE3INTERVENTIONAL

Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

This research trial is designed for people with advanced breast cancer that is hormone receptor-positive and HER2-negative, and also has certain genetic changes (BRCA1, BRCA2, or PALB2m). Researchers want to find out if a new combination of medicines, saruparib and camizestrant, is more effective than current standard treatments. Participants will be split into three groups: one receiving the new combination, another receiving a standard treatment (a CDK4/6 inhibitor plus endocrine therapy), and a third receiving a CDK4/6 inhibitor plus camizestrant. The aim is to understand which treatment better controls cancer growth and improves outcomes for patients. This is a Phase 3 study, meaning these treatments have already been tested in earlier stages.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
500
Start
01 Aug 2024
Estimated completion
18 Oct 2030

What is this study about?

This study is for individuals facing advanced breast cancer. This means the cancer may have spread to other parts of the body or is locally advanced and cannot be cured by surgery. The specific type of breast cancer being studied is called 'hormone receptor-positive and HER2-negative'. This means the cancer cells respond to hormones, and they don't have high levels of a protein called HER2. Crucially, participants in this study must also have certain genetic changes (mutations) in their cancer, specifically in genes named BRCA1, BRCA2, or PALB2.

The main goal of this research is to compare new treatment approaches. We want to see if combining a new drug called saruparib (also known as AZD5305) with another medicine called camizestrant works better than treatments currently used. Current treatments often involve a CDK4/6 inhibitor (like abemaciclib, ribociclib, or palbociclib) combined with endocrine therapy (like fulvestrant, letrozole, anastrozole, or exemestane). A third group will receive a CDK4/6 inhibitor along with camizestrant.

By comparing these different combinations, doctors hope to find a more effective way to treat this specific type of advanced breast cancer. Finding better treatments could help people live longer and have a better quality of life. This is a Phase 3 trial, which means the drugs have already been tested for safety in smaller groups and are now being compared to standard care in a larger number of people to confirm their effectiveness.

Key takeaways

  • Tests new drug combinations for specific advanced breast cancer.
  • Targets breast cancer with BRCA1, BRCA2, or PALB2 gene changes.
  • Compares a new combination to existing standard treatments.
  • Participation involves random assignment to a treatment group.
  • Requires regular check-ups and monitoring for safety and effectiveness.

Who may be eligible?

To join this study, you need to be an adult woman (before, during, or after menopause) or an adult man. You must have advanced breast cancer that doctors have identified as 'hormone receptor-positive' and 'HER2-negative'. It's also important that your cancer has a specific genetic change (mutation) in one of these genes: BRCA1, BRCA2, or PALB2. Your general health should be good enough to participate, meaning you can mostly carry out your daily activities.

There are several reasons why you might not be able to join. For example, if you have a history of certain serious blood conditions (like MDS/AML) or problems that make you bleed easily. You also can't have other serious or uncontrolled health issues like certain heart conditions, active infections (such as hepatitis B or C, HIV, or tuberculosis), or cancer in other parts of your body that has spread to your brain or spinal cord. If you've recently had major surgery or radiation treatment, or if you have severe sickness or gut problems, you might not be eligible.

Quick self-check
  • Are you an adult (male or female)?
  • Do you have hormone receptor-positive, HER2-negative advanced breast cancer?
  • Has your cancer been tested for BRCA1, BRCA2, or PALB2 gene changes, and do you have one?
  • Are you generally well enough to do most daily activities?
  • Do you have any serious heart problems or active infections?
  • Have you had certain serious blood conditions in the past?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be randomly assigned to one of three treatment groups, like flipping a coin. You'll have a 2 in 5 chance of getting the saruparib and camizestrant combination, a 2 in 5 chance of getting a standard CDK4/6 inhibitor with endocrine therapy, and a 1 in 5 chance of getting a CDK4/6 inhibitor with camizestrant. You'll receive your assigned treatment until your cancer gets worse, you experience side effects that are too difficult to manage, or you decide you no longer wish to participate.

The study involves regular check-ups with the study team. These visits will include various tests such as blood tests, scans (like CT or MRI), and possibly heart tests to monitor how you're responding to the treatment and to check for any side effects. You'll be taking medications, likely in pill form, or as injections, depending on your assigned treatment. The total duration of your participation will depend on how you respond to the treatment and until one of the stopping criteria is met.

Potential risks and benefits

Participating in this study might offer the benefit of receiving new or different treatments for your advanced breast cancer that are not yet widely available. These treatments could potentially be more effective than standard options. However, as with any medical treatment, there are potential risks, including side effects from the medications. The study team will closely monitor you for any side effects and will explain these to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (298)

  • Research Site
    Gilbert, United States· Recruiting
  • Research Site
    Fountain Valley, United States· Recruiting
  • Research Site
    Glendale, United States· Recruiting
  • Research Site
    Los Angeles, United States· Recruiting
  • Research Site
    Newport Beach, United States· Recruiting
  • Research Site
    Aurora, United States· Recruiting
  • Research Site
    Grand Junction, United States· Withdrawn
  • Research Site
    Hollywood, United States· Recruiting
  • Research Site
    Jacksonville, United States· Recruiting
  • Research Site
    Orlando, United States· Withdrawn
  • Research Site
    Chicago, United States· Recruiting
  • Research Site
    Evanston, United States· Recruiting

+286 more sites — see the official record for the full list.

Common questions

What kind of breast cancer is this study for?

This study is for advanced breast cancer that is hormone receptor-positive, HER2-negative, and has specific genetic changes in BRCA1, BRCA2, or PALB2 genes.

What are the main treatments being tested?

The study compares a new combination of saruparib and camizestrant with standard treatments (CDK4/6 inhibitors plus other hormone therapies or camizestrant).

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of three treatment groups, like drawing lots. You won't know which treatment you're getting until after you've joined.

How long will I be in the study?

You will stay in the study until your cancer progresses, you have side effects that are too severe, or you decide to stop participating.

What kind of tests will I have?

You'll have regular check-ups, blood tests, scans (like CT or MRI), and possibly heart tests to monitor your health and treatment response.

How to find out more

AstraZeneca Clinical Study Information Center

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

Interested in taking part?

Register your interest

Share your details and the research team for "Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 I…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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