Working Toward the Next Generation of Endocrine Therapy in Early Breast Cancer

Many people with early breast cancer are given hormone therapy (also known as endocrine therapy) to reduce the chances of their cancer coming back. The CAMBRIA-2 study is looking into an alternative hormone therapy option by comparing an investigational medication to current standard of care options. The CAMBRIA-2 study is funded by AstraZeneca.

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About Breast Cancer

Breast cancer is a disease in which cells in the breast grow out of control. There are different kinds of breast cancer. The CAMBRIA-2 study is looking for people with ER+/HER2- early breast cancer. Many people with early breast cancer are given hormone therapy (also known as endocrine therapy) to reduce the chances of their cancer coming back.

The CAMBRIA-2 study is looking into an alternative hormone therapy option by comparing an investigational medication to current standard of care options. Early breast cancer is where the tumor is confined to the breast and surrounding lymph nodes. It has not spread to other parts of the body. 

ER+/HER2- breast cancer is the most common type of breast cancer; it overexpresses estrogen receptors (ER+) but not the HER2 receptor (HER2-).

About the CAMBRIA-2 Study

The goal of this study is to learn more about an investigational medication which is not currently approved by any health authority, except for use in research studies, like CAMBRIA-2.

We want to see if endocrine therapy using the investigational medication is better at preventing cancer recurrence (cancer that comes back) than the current standard hormone therapy. We also want to better understand breast cancer overall and the associated health problems.

Who is Eligible to Take Part?

To pre-qualify for this study, you must:
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Be at least 18 years old.

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Have a diagnosis of ER+/HER2- early breast cancer with no metastasis (cancer stage I to III).

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Be within 12 months of surgery to remove the tumor.

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Be within 12 weeks of last neo-adjuvant chemotherapy/radiotherapy treatment (if applicable).

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Be within 12 weeks of starting hormone therapy or have not received any hormone therapy.

All study-required visits, tests and medications will be provided at no cost to you.  In addition, reimbursement for study-required travel may be available.

Study Summary

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Medical condition

ER+/HER2- early breast cancer.
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Study duration

Approximately 10-14 years with up to 7 years of treatment and then follow up every year until 10 years after the last person enters the study.

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Study locations

This is a global study which will enroll participants across North America, South America, Europe, Asia-Pacific and Australia.

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This is a Phase 3 study

The investigational medication will be given to around 5,500 people. Researchers are working to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational medication or treatment to be used appropriately.

What Does it Mean to Participate?

The study consists of 3 periods as per the below diagram: a screening period for up to 28 days; a treatment period of 7 years; and a follow-up period to check on your health status until 10 years after the last person joins the study. This means that you may be in this study between 10-14 years. You can choose to leave the study at any time.

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Screening Period

If you choose to participate you will undergo a series of tests which may require several visits to your study doctor or other specialists, to confirm if you qualify for the study. This is called screening and the overall time window for these tests to be done is up to 28 days long. Where possible, your study doctor will use assessments and samples available from before screening.

If you meet the screening entry criteria, you will be randomly assigned to receive either Study drug A taken orally once daily or standard endocrine therapy (ET) taken orally once daily.  Randomly assigned means that whatever treatment you get will be by chance, like flipping a coin or drawing names out of a hat. You have a 1 in 2 (50%) chance of being given either treatment. In addition to Study drug A or standard ET, you may also receive an additional drug called Study drug B for the first 2 years of your treatment.

Treatment Period – up to 7 years

The treatment period of the study is 7 years. During this time, you’ll attend visits at the site and be contacted by telephone.

Before you start the follow up period, you will have two final visits, end of treatment visit and safety follow up visit. The end of treatment visit is where you stop taking the study treatment and the safety follow up visit will be conducted about 1 month after your end of treatment visit.

Follow Up Period – Once a year

During the follow up period, you will continue to be followed-up every year to check on your health status and will attend a visit once a year. These follow-up visits can occur via telephone/video or onsite and will continue until 10 years after the last person joins the study.

What are the possible benefits and risks?

There is no guaranteed benefit to participating in the CAMBRIA-2 study. However, your participation will help determine whether the investigational medication can be tolerated and effective for patients with early HR+/HER2- breast cancer and may help deliver an alternative therapy option for future patients.

FAQs

What is a clinical study?

Clinical studies evaluate whether a medicine, treatment, or device can be tolerated and are effective for humans. Clinical studies are scientific studies in which investigational medicines and treatments are tested in a controlled way to make sure they can be tolerated and are effective for people who may need them. They are one of the most important steps in bringing potential medications to patients.

Why is clinical research important?

Clinical research adds to medical knowledge and helps bring potential medications to people with medical conditions. In order to make potential medications available to the public they need to be studied in clinical studies. Clinical studies rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for an investigational medication to reach the public. All investigational medical treatments and medications have gone through clinical studies to make sure that they can be tolerated and effective.

Who runs clinical studies?

A clinical study is often run by a global team and can be sponsored, or funded, by pharmaceutical companies, academic medical centers, volunteer groups, or health care providers. This clinical study is led by a Principal Investigator, who is a medical doctor. The research team may include doctors, nurses, social workers, and other health care professionals.

What are the phases of clinical research?

Phase I 

These are studies in humans with a small number of participants. The main objectives are to investigate: 

  • Safety profile of the study medication 
  • How the study medication is absorbed by the body and what dosage should be used 
  • How the study medication is removed from the body 
  • Potential side effects 

Phase II 

Small studies with around 100-300 participants. The main objectives are to investigate: 

  • Safety profile of the study medication 
  • Whether the study medication works for a particular disease 
  • The best potential dose of the study medication 

Phase III 

Large studies with around 500 or more participants. These are the main studies for final approval by health authorities. The main objectives are to investigate: 

  • Safety profile and side effects in bigger populations 
  • Whether the study medication works for a particular disease 
  • How the treatment compares to already existing standard therapies 

Phase IV 

Large studies in patients after the study medication has been approved by regulatory authorities for prescription use. The main objectives are to investigate: 

  • Side effects during day-to-day use in the population 
  • Risks and benefits over a longer period of time 

What does it mean to participate?

Before taking part in a study, you will be asked to read and sign an informed consent document to ensure: 

  1. You understand the study, including all the study procedures, risks and potential side effects of the study medication.
  2. You agree to volunteer. 
  3. You understand that you can leave the study at any time for any reason.  

During the consenting process, you will have the opportunity to ask the site staff any questions you may have. Taking part in a clinical study typically involves taking tests to determine if you are eligible for the study. If you qualify, you will visit the clinic regularly to receive the investigational medication, undergo tests or procedures, and assess your disease. The study staff will monitor your progress and well-being.