Active not recruitingPHASE3INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

This study, called 'lidERA Breast Cancer,' is looking at how well a new medicine, Giredestrant, works and if it's safe for people with early breast cancer. It compares Giredestrant to the usual hormone treatments doctors choose. This study is for people who have early-stage breast cancer that is positive for oestrogen receptors (ER+) and negative for HER2. Participants will have already undergone surgery for their cancer. The aim is to find effective treatments to help prevent the cancer from coming back. This is a large, international study involving many different hospitals.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

4,170

Start

27 Aug 2021

Estimated completion

30 Sep 2033

Early Breast Cancer

What is this study about?

Imagine you or someone you know has been diagnosed with early breast cancer. After surgery, doctors often recommend further treatments, like hormone therapy, to help stop the cancer from returning. This study is exploring a new treatment called Giredestrant. It's designed to work specifically on breast cancers that are sensitive to oestrogen, a natural hormone in the body. If your cancer is ER-positive and HER2-negative, this is the type of cancer this study is focusing on.

The main goal of the study is to see if Giredestrant is better or just as good as the standard hormone treatments that doctors currently prescribe. It also checks how safe Giredestrant is and what side effects it might have. Finding new, effective, and safe treatments is important for improving the care of people with early breast cancer. By joining a study like this, you could help doctors learn more about the best ways to treat breast cancer in the future.

This is a 'Phase 3' study, which means Giredestrant has already been tested in smaller groups of people and shown some promise. Now, it's being tested on a larger scale to confirm its benefits and understand its effects fully. Participants will be randomly assigned to receive either Giredestrant or one of the standard hormone therapies, ensuring a fair comparison.

Key takeaways

This study compares a new drug (Giredestrant) with standard hormone therapy.
It's for people with early-stage, ER-positive, HER2-negative breast cancer.
Participants must have already had surgery for their breast cancer.
The study aims to improve long-term outcomes and prevent cancer recurrence.
You will receive close medical monitoring throughout your participation.

Who may be eligible?

This study is designed for adults aged 18 or older who have been diagnosed with early breast cancer. Your breast cancer must be of a specific type: it needs to be 'estrogen receptor-positive' (meaning it grows in response to hormones) and 'HER2-negative'. Doctors will check this from a sample of your tumour.

You must have already had surgery to remove your main breast tumour and any affected lymph nodes. If you've also had chemotherapy before, that's fine, as long as it's completed before you start the study. All side effects from any previous treatments should have mostly cleared up. You'll also need to be able to provide a tissue sample from your original tumour so doctors can do further tests.

Even if your cancer had multiple spots in the breast, or if it was in different areas of the breast, you might still be able to join as long as all those spots were also ER-positive and HER2-negative. You should not have started any hormone therapy yet, and it should be within 12 months since your surgery.

Quick self-check

Are you 18 years old or older?
Has your doctor confirmed your breast cancer is ER-positive and HER2-negative?
Have you already had surgery for your breast cancer and had most side effects clear up?
If you had chemotherapy, has it been at least three weeks since your last dose?
Are you able to provide a tissue sample from your original tumour?
Have you not started any hormone therapy yet, and is it within 12 months of your breast cancer surgery?

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 be randomly assigned to receive either the new drug Giredestrant or one of the standard hormone therapies currently used. This is like flipping a coin – it's completely by chance. You will take the assigned medication regularly, as instructed by the study team.

You will have several visits to the hospital or clinic to check on your health and how you are responding to the treatment. These visits will include check-ups, blood tests, and sometimes scans. The study team will explain exactly what is involved in each visit. They will also keep track of any side effects you might experience. The total duration of your participation, including follow-up, will be determined by the study design, and the team will provide you with all the details.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new treatment that might be more effective than current options, and receiving close medical monitoring. However, there are also potential risks, including side effects from the study medication, which may be unknown or severe. You will be fully informed about all known risks before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (622)

Southern Cancer Center
Daphne, United States
CBCC Global Research Inc., at Comprehensive Blood and Cancer Center
Bakersfield, United States
St Joseph Heritage Healthcare
Fullerton, United States
Long Beach Memorial Medical Center
Long Beach, United States
Cancer Blood and Specialty Clinic
Los Alamitos, United States
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange, United States
Kaiser Permanente - San Diego
San Diego, United States
Sansum Clinic
Santa Barbara, United States
UCLA Hematology/Oncology
Santa Monica, United States
Torrance Memorial Physician Network/Cancer Care
Torrance, United States
Kaiser Permanente - Vallejo
Vallejo, United States
Rocky Mountain Cancer Centers (Longmont) - USOR
Longmont, United States

+610 more sites — see the official record for the full list.

Common questions

What does 'ER-positive, HER2-negative' mean?

This describes how your breast cancer cells behave. 'ER-positive' means the cancer cells grow in response to the hormone oestrogen. 'HER2-negative' means the cancer cells don't have too much of a protein called HER2.

What is Giredestrant?

Giredestrant is a new medicine being tested. It's designed to block the effects of oestrogen on breast cancer cells, potentially stopping them from growing.

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

No, this is an 'open-label' study, meaning both you and the doctors will know which treatment you are receiving (either Giredestrant or a standard hormone therapy chosen by your doctor).

Can I still join if I've had chemotherapy?

Yes, if you've had chemotherapy, you can still participate as long as it finished at least 21 days before you start the study, and any side effects have mostly gone away.

How long will I be in the study?

The study team will tell you the exact length of time, including how long you'll take the treatment and how long you'll have follow-up appointments.