AuthorisedTherapeutic confirmatory (Phase III)Interventional

A phase III study comparing the concurrent versus the sequential administration of chemotherapy and aromatase inhibitors, as adjuvant treatment of post-menopausal patients with endocrine-responsive early breast cancer

This study is for women who have gone through menopause and have an early form of breast cancer that is affected by hormones. Many breast cancers are this type, meaning two main treatments might be used: chemotherapy and hormone therapy. Doctors are not yet sure whether it's better to give these treatments together at the same time, or one after the other. This study aims to find the best way to combine them to help prevent the cancer from coming back. It will compare different hormone therapy drugs like exemestane, letrozole, and anastrozole. The main thing they will measure is how long patients stay free of cancer coming back, or any serious related health issues.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

IRCCS Ospedale Policlinico San Martino

Enrolment target

1,014

Start

03 Feb 2025

Breast cancer is the most common form of cancer among women in North America Europe and Latin America. Beacause nearly 80% of breast cancers are endocrine-responsive tumors

What is this study about?

Breast cancer is a common cancer for women, and about 8 out of 10 cases are what we call 'hormone-responsive.' This means the cancer cells grow in response to hormones in the body. If you have this type of early breast cancer and have gone through menopause, your doctors might suggest two main types of treatment: chemotherapy, which uses strong drugs to kill cancer cells, and hormone therapy (also called endocrine therapy), which blocks the effects of hormones on cancer cells.

At the moment, doctors are not entirely sure about the best way to give these two treatments. Should they be given at the same time, or should one be given first, followed by the other? This study, called a Phase III trial, is designed specifically to answer that question. It's a very important study because it could help doctors decide the best treatment plan for many women in the future.

Participants in this study will receive either chemotherapy and hormone therapy at the same time, or one after the other, using common hormone therapy drugs such as exemestane, letrozole, or anastrozole. The main goal is to see which approach is better at preventing the cancer from coming back – whether locally in the breast, nearby, or in other parts of the body. They will also look at how long people live and if there are any side effects from the treatments.

Key takeaways

This study aims to find the best timing for breast cancer treatments.
It's for post-menopausal women with early, hormone-responsive breast cancer.
It compares giving chemotherapy and hormone therapy at the same time versus one after the other.
The goal is to see which approach is better at preventing the cancer from returning.
Common hormone therapy drugs like exemestane, letrozole, and anastrozole are used.

Who may be eligible?

This study is for women who are at least 18 years old and have already gone through menopause. You would also need to have been diagnosed with early breast cancer that is known to be 'hormone-responsive,' meaning its growth is affected by hormones.

The study is specifically looking at patients who would normally be considered for both chemotherapy and hormone therapy as part of their treatment plan. The study will confirm you meet all the medical requirements to take part, including a review of your overall health and breast cancer details.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you at least 18 years old?
Have you gone through menopause?
Have you been diagnosed with early breast cancer that is known to be hormone-responsive?
Are you being considered for both chemotherapy and hormone therapy as part of your treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two treatment groups – either receiving chemotherapy and hormone therapy at the same time, or one after the other. The specific treatments you receive will include chemotherapy and one of the hormone therapy drugs (exemestane, letrozole, or anastrozole). You will have regular visits to the clinic for your treatments, check-ups, and tests like blood tests and scans, to monitor your health and how well the treatment is working. The study will closely track your health and any changes for several years, looking to see if the cancer returns or if you have any new health issues. The exact number of visits and the full length of follow-up will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer you access to new ways of combining existing treatments, which could potentially be more effective in preventing your breast cancer from returning. However, there are also potential risks related to the treatments themselves, such as side effects from chemotherapy or hormone therapy, which the study team will monitor closely. There might also be unknown risks, and the combination of treatments could have different side effects than when given separately. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What does 'hormone-responsive' breast cancer mean?

It means the cancer cells have receptors that allow them to use hormones like oestrogen to grow. Hormone therapy drugs block this process.

What is the difference between chemotherapy and hormone therapy?

Chemotherapy uses strong medicines to kill fast-growing cells, including cancer cells, throughout the body. Hormone therapy uses medicines to block or reduce the hormones that can help cancer cells grow.

What is a 'Phase III' study?

A Phase III study is a large-scale study that compares a new treatment or approach with standard treatment, or compares two different treatment approaches, to see if it's better or safer.

Will I know which treatment group I'm in?

The study team will explain how treatments are assigned. Sometimes, in studies like this, patients are randomly assigned to a group, and you might know which treatment approach you are receiving.

What happens if the cancer comes back?

The study will carefully monitor for any signs of the cancer returning. If it does, the study team will guide you on the next steps for your treatment, regardless of your participation in the trial.