RecruitingPHASE3INTERVENTIONAL

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

This study, called CAMBRIA-2, is testing a new medication called camizestrant for people with a specific type of early breast cancer (ER+/HER2-). This is a 'Phase III' study, meaning it's a key step to see if this new drug is better than existing standard hormone therapies. The main goal is to find out if camizestrant can reduce the chance of the cancer returning, especially for those at a higher risk. The study will involve patients taking the treatment for 7 years, and they'll be followed for much longer to check their health and cancer status. It's open to both men and women aged 18 and over who have completed their initial breast cancer treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

5,500

Start

05 Oct 2023

Estimated completion

06 May 2037

Breast Cancer, Early Breast Cancer

What is this study about?

This important study, named CAMBRIA-2, is investigating a new medication called camizestrant. It's designed for people who have been diagnosed with a type of early breast cancer that is sensitive to hormones (known as ER+/HER2- breast cancer). The main idea behind this research is to see if camizestrant can be more effective than the standard hormone therapies currently used to help prevent breast cancer from returning after initial treatment.

After you've had surgery, and possibly chemotherapy or radiotherapy, for this type of breast cancer, hormone therapy is often given for several years to lower the risk of the cancer coming back. This study is focusing on patients who are considered to have a medium to high risk of their cancer returning. Researchers want to compare camizestrant with the usual hormone treatments like tamoxifen, anastrozole, letrozole, or exemestane, to see which approach offers the best long-term outcomes.

The study will follow participants for many years to track their progress. The main things researchers will be looking at include whether the cancer comes back, how long people live without the cancer returning, and their overall quality of life and safety while taking the medication. This kind of research is crucial for developing better and more effective treatments for breast cancer patients in the future.

Key takeaways

Tests a new drug (camizestrant) for common early breast cancer.
Aims to prevent cancer returning, especially for higher-risk patients.
Compares new drug to usual hormone therapies.
Treatment lasts 7 years, with long-term follow-up.
Open to men & women who completed initial breast cancer treatments.
Researchers will check for cancer recurrence, overall survival, and safety.

Who may be eligible?

This study is looking for both men and women, aged 18 or older. To be considered, you must have been diagnosed with early-stage breast cancer that is hormone-sensitive (ER+/HER2-) and has not spread to other parts of your body. You should have already completed your initial treatments like surgery, with or without radiotherapy, and potentially chemotherapy.

There are also some important timing requirements: you need to be enrolled in the study within 12 months of your breast surgery, and you might have started up to 12 weeks of hormone therapy before joining. You'll also need to be generally well and able to carry out your daily activities without significant difficulty, and your blood tests for organ function should be within a healthy range.

However, you won't be able to join if your cancer has spread, if you've already had a complete response to neoadjuvant therapy (treatment before surgery), or if you've had other cancers recently (unless it was a very low-risk type like some skin cancers). Also, if you have severe heart problems, an irregular heartbeat, are pregnant or breastfeeding, or have previously taken camizestrant or similar drugs, you would not be eligible.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with early-stage, hormone-sensitive (ER+/HER2-) breast cancer?
Have you completed your initial breast cancer surgery and any necessary chemotherapy or radiotherapy?
Is it less than 12 months since your breast surgery?
Do you feel generally well and able to keep up with daily activities?

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

What does participation involve?

If you decide to take part in this study, you will either receive the new drug, camizestrant, or one of the standard hormone therapies (tamoxifen, anastrozole, letrozole, or exemestane). You would take the study medication for approximately 7 years. During this time, you would have regular visits to the hospital or clinic for check-ups, blood tests, and to discuss any side effects with the study team. Some patients might also be taking another medication called abemaciclib alongside the study treatment, if recommended by their doctor.

After the 7 years of treatment, the study team will continue to follow your health and cancer status for several more years – potentially up to 10 years after the last patient has joined the study. This long-term follow-up is important to understand the full effects of the treatment. The number and frequency of visits, along with specific assessments, would be outlined in detail by the study staff.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment that isn't yet widely available, and close monitoring by a medical team. However, there are also potential risks, as with any medication. Camizestrant is an investigational drug, meaning its full effects and side effects are still being studied, and it might have side effects that are not yet fully understood. Standard hormone therapies also have known side effects. There is no guarantee that the new treatment will be more effective than existing ones, or that you will personally benefit from taking part. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (794)

Research Site
Dothan, United States· Recruiting
Research Site
Phoenix, United States· Recruiting
Research Site
Tucson, United States· Recruiting
Research Site
Fayetteville, United States· Recruiting
Research Site
Duarte, United States· Recruiting
Research Site
Fountain Valley, United States· Recruiting
Research Site
Greenbrae, United States· Not yet recruiting
Research Site
Irvine, United States· Recruiting
Research Site
La Jolla, United States· Recruiting
Research Site
Los Angeles, United States· Recruiting
Research Site
Monterey, United States· Recruiting
Research Site
Walnut Creek, United States· Recruiting

+782 more sites — see the official record for the full list.

Common questions

What type of breast cancer is this study for?

This study is for early-stage breast cancer that is sensitive to hormones (ER+/HER2-), meaning its growth is affected by hormones.

What is unique about camizestrant?

Camizestrant is a new type of drug being studied to see if it can more effectively block the hormone effects that help breast cancer grow, compared to current standard treatments.

How long will I be on the treatment?

The treatment part of the study is planned to last for 7 years.

Will I know if I'm getting the new drug or standard treatment?

This is an 'open-label' study, which means both you and your study doctor will know whether you are receiving camizestrant or a standard hormone therapy.

Can I still receive chemotherapy or radiotherapy before joining?

Yes, you must have completed any necessary surgery, with or without chemotherapy or radiotherapy, before joining the study.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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