Active not recruitingPHASE3INTERVENTIONAL

Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy

This study is for women who have had breast cancer that hasn't spread and are at a high risk of it returning. They have 'ER-positive, HER2-negative' breast cancer and have already started or are about to start hormone therapy. The researchers want to see if adding an investigational drug called everolimus to their current hormone therapy can help prevent the cancer from coming back more effectively than hormone therapy alone. This is a Phase 3 trial, meaning it's a large study to confirm the drug's effectiveness and safety. The goal is to improve the long-term outlook for women whose cancer is likely to return even after initial treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

UNICANCER

Enrolment target

1,278

Start

01 Mar 2013

Estimated completion

01 Jun 2030

Primary Non-metastatic Breast Cancer Who Remain Disease-free

What is this study about?

Many women with breast cancer that hasn't spread are treated with surgery, and often chemotherapy or radiotherapy, followed by hormone therapy. Even after all this treatment, some women are at a higher risk of their cancer returning, especially if many lymph nodes were affected or their tumour was large. While hormone therapy is very effective, doctors are always looking for new ways to make sure the cancer stays away for as long as possible.

This study is looking at a drug called everolimus. We know that certain pathways in the body play a role in how breast cancer cells grow and how they might become resistant to hormone treatments. Everolimus works by targeting one of these pathways. The idea is that by adding everolimus to standard hormone therapy, it might provide an extra layer of protection, making the hormone therapy even more powerful at keeping the cancer from coming back.

The main goal of this research is to find out if adding everolimus to standard hormone therapy can improve the chances of women staying free of cancer in the long term. If the study shows positive results, it could change how doctors treat women at high risk, potentially helping more women avoid their cancer returning and improving their lives.

Key takeaways

This study is for women with a high risk of their ER-positive, HER2-negative breast cancer returning.
It tests if adding the drug everolimus to standard hormone therapy helps prevent cancer recurrence.
Participants will receive either everolimus or a placebo alongside their hormone therapy.
The study aims to improve long-term outcomes for women at high risk.
It's a Phase 3 study, meaning it's a large trial to confirm effectiveness and safety.

Who may be eligible?

This study is designed for women who are at least 18 years old and have been diagnosed with breast cancer that hasn't spread to other parts of the body (this is called 'non-metastatic'). To be considered, your breast cancer must be 'ER-positive and HER2-negative', which are specific features of cancer cells that doctors test for. You should have already had your primary breast tumour removed by surgery.

You would be considered for this study if your breast cancer has a high risk of returning. This high risk is determined in a few ways: for example, if four or more lymph nodes were found to contain cancer, or if you still had cancer in one or more lymph nodes after chemotherapy before surgery. Additionally, some women with 1-3 affected lymph nodes whose tumour shows a high risk using a special genetic test called 'EndoPredict' might also be eligible.

Finally, you should be in good general health, have healthy blood, liver, and kidney function, and either be about to start hormone therapy or have been on it for up to four years already. You cannot have any signs of the cancer having spread or returned in other areas of your body.

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 at least 18 years old?
Do you have ER-positive, HER2-negative breast cancer that has been removed by surgery?
Are you considered at high risk for your breast cancer returning (e.g., several lymph nodes affected, or specific genetic test results)?
Are you about to start or have you been on hormone therapy for less than four years?
Is your breast cancer non-metastatic (meaning it hasn't spread to other body parts)?
Are you generally in good health with healthy organ function?

Answer every question to see your result.

What does participation involve?

We expect this section to be populated with details specific to this trial. However, based on the provided information, a typical study like this would involve:

* **Regular Visits:** You would likely have scheduled visits to the hospital or clinic for check-ups, blood tests, and to receive your study medication (either everolimus or a placebo, which looks identical but contains no active drug). * **Medication:** You would take either everolimus or the placebo, in addition to your standard hormone therapy, for a specific period, likely several years. * **Assessments:** Doctors would regularly monitor your health, take blood samples to check for side effects, and conduct scans to ensure the cancer has not returned. * **Follow-up:** Even after you stop taking the study medication, you would continue to be followed up, possibly with annual checks for up to 10 years, to see how you are doing in the long term and to gather important information about the results of the treatment. * **Total Duration:** The active treatment phase would be several years, followed by a long-term monitoring period.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit if everolimus proves to be more effective than hormone therapy alone at preventing your cancer from returning, potentially improving your long-term health. However, there's also a chance you could receive the placebo, meaning you wouldn't get the potential benefits of the experimental drug. Everolimus, like all medications, can have side effects, and these would be carefully monitored throughout the study. Your safety and well-being are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

Centre Leon Berard
Verified postcode
Lyon, France
Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What is 'ER-positive, HER2-negative' breast cancer?

These are common types of breast cancer. 'ER-positive' means the cancer cells grow in response to the hormone oestrogen, and 'HER2-negative' means they don't have too much of a protein called HER2. This helps doctors decide the best treatments.

What is hormone therapy?

Hormone therapy is a treatment that either lowers the amount of hormones in the body or blocks their action, starving ER-positive cancer cells of the hormones they need to grow.

What is everolimus?

Everolimus is a type of drug called a 'targeted therapy' that aims to block specific pathways in cancer cells that help them grow. It's being studied here to see if it can boost the effects of hormone therapy.

What is a 'placebo'?

A placebo is an inactive substance that looks exactly like the study drug. In clinical trials, some participants receive the active drug, and others receive a placebo, to fairly compare the drug's effects.

What does 'high-risk of relapse' mean?

It means there's a higher chance of the cancer returning after initial treatment, based on factors like how many lymph nodes were affected or specific features of the tumour. This study aims to reduce that risk.