Working Toward the Future of Breast Cancer Care
Many people with breast cancer are on hormone therapy to try to reduce the chances of their cancer coming back. The CAMBRIA-1 study is looking into an alternative option by comparing an investigational medication to current standard of care options.
About Breast Cancer
Breast cancer is a disease in which cells in the breast grow out of control. There are different kinds of breast cancers, and the CAMBRIA-1 study is looking for people with ER+/HER2- early breast cancer.
In early breast cancer, the tumour is confined to the breast and surrounding lymph nodes and has not migrated to other parts of the body.
ER+/HER2- breast cancer is the most common type of breast cancer; it overexpresses oestrogen receptors (ER+) but not the HER2 receptor (HER2-).
About the CAMBRIA-1 Study
The goal of this study is to learn more about an investigational medicinal product which hasn’t been fully tested and is not approved by any health authority, except for use in research studies like this.
We want to see if extended therapy with the investigational medicinal product is better at preventing cancer recurrence (cancer that comes back) than continuing standard hormone therapy. We also want to better understand breast cancer overall and the associated health problems.
Who is eligible to take part?
Be at least 18 years old.
Have a diagnosis of ER+/HER2- early breast cancer.
Have had surgery to remove the tumour (with or without radiotherapy or/and neo-adjuvant chemotherapy).
Have been on hormone therapy for at least 2 but no more than 5 years.
All study-required visits, tests and medications will be provided at no additional cost to you. In addition, reimbursement for study-required travel may be available.
Study summary
Study Sponsor
AstraZeneca
Medical condition
ER+/HER2- early breast cancer
Study duration
5 years of treatment with an additional 5 to 8 years follow up.
Study locations
This is a global study which will enrol participants across North America, South America, Europe, South Africa and Asia-Pacific.
This is a Phase 3 Study: The investigational medication has already been tested in phase 1 and phase 2 studies to see how well it is tolerated. Now, it will be given to a large group of people. Researchers are working to assess if the investigational medication improves outcomes compared to standard endocrine therapy, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational medicinal product or treatment to be used appropriately.
What does it mean to take part?
If you qualify and choose to participate you will undergo a series of tests which may require several visits to your doctor or other specialists. This is called screening and the overall time window for these tests to be done is up to 28 days long.
After the screening period, if you meet the eligibility criteria for participation in the trial, you will be included in the trial with a 50% chance to receive either the investigational medicinal product or to continue with your current treatment. You will be in the treatment period of the study for 5 years, after which there is a follow-up period.
Treatment Period – 5 Years
The treatment period of the study is 5 years. During this time, you’ll attend visits at the site. You will also have eye test visits.
Follow Up Period – 1-2 times a year for up to 13 years
After the 5-year treatment period, you will continue to be followed-up every year to check on your health status. This will continue until 10 years after the last person joins the study. This means that you may be in this study for approximately 10-13 years.
What are the possible benefits and risks?
There is no guaranteed benefit to participating in the CAMBRIA-1 study. The research results however, may provide further insight to breast cancer doctors in the future on how to better treat patients with the same disease as you.
FAQs
What is a clinical study?
Clinical studies are scientific studies in which investigational medicines and treatments are tested in a controlled way to make sure they are appropriate 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 be studied in clinical trials. Clinical trials 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 trials to make sure that they are tolerated and effective.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centres, volunteer groups or healthcare providers. Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other healthcare professionals.
What are the phases of clinical research?
Phase I
The first study in humans. These are small studies with approximately 20-100 participants, mostly in healthy volunteers, but in some diseases like cancer, the studies are only done with patients. 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 100-500 participants. The main objectives are to investigate:
- Ongoing safety profile
- 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:
- 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 (or public use if it isn’t a medicine that requires a prescription). 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 take part?
Before taking part in a trial, you will be asked to read and sign an informed consent document to ensure:
- You agree to volunteer.
- You understand the study, including all the study procedures, risks and potential side effects of the study medication.
- 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 trial typically involves taking tests to determine if you are a match 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.