Active not recruitingPHASE2INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

This study is investigating a new medication called giredestrant for certain types of advanced breast cancer. It's designed for people whose cancer has grown even after they've had one or two other treatments. The study is comparing giredestrant with standard hormone therapies, such as fulvestrant or aromatase inhibitors, to see how well it works and if it's safe. It specifically focuses on breast cancer that is Estrogen Receptor (ER)-positive and HER2-negative, meaning its growth is often linked to the hormone oestrogen. This research aims to find better treatment options for patients living with this type of advanced breast cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

303

Start

27 Nov 2020

Estimated completion

25 Aug 2027

Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

What is this study about?

This study is about finding better ways to treat a specific type of breast cancer that has spread to other parts of the body (metastatic) or grown into nearby tissues (locally advanced). This breast cancer is called 'Estrogen Receptor-positive' (ER-positive) because its growth is often encouraged by the hormone oestrogen. It's also 'HER2-negative,' meaning it doesn't have too much of a protein called HER2. For many people, hormone-blocking treatments are very important for managing this type of cancer.

Researchers are testing a new drug called giredestrant. They want to compare it with the standard hormone treatments that doctors currently use, such as fulvestrant or other hormone therapies. The main goal is to see if giredestrant is more effective at stopping the cancer from growing, or even shrinking it, and if it's safe for patients to use. This is a 'Phase 2' study, which means it's a step closer to understanding whether this new drug could become a helpful option for people in the future.

This research is important because it offers the possibility of new treatment options for patients whose ER-positive, HER2-negative breast cancer has continued to grow despite having received previous treatments. Finding more effective and well-tolerated treatments can significantly improve the lives of those living with advanced breast cancer.

Key takeaways

Tests a new drug (giredestrant) for specific advanced breast cancer.
Compares giredestrant to standard hormone treatments.
For ER-positive, HER2-negative breast cancer that has grown after earlier treatments.
Aims to find more effective and safe treatment options.
Involves regular clinic visits, tests, and closely monitored medication.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to be a woman who has gone through menopause, or a woman who still has periods (premenopausal/perimenopausal), or a man. If you are a woman who still has periods, or a man, you would need to be willing to take another medication alongside the study treatment that helps manage hormone levels.

The study is for people with advanced breast cancer that is ER-positive and HER2-negative, and it cannot be treated with surgery or radiation to cure it. Your cancer must have continued to grow after you've had one or two previous lines of treatment for advanced or metastatic cancer.

There are also some reasons why you might not be able to join. For example, if you've recently had certain other investigational treatments, or if your cancer is causing severe problems in certain organs like your brain or heart. People who are pregnant or breastfeeding also cannot participate.

Quick self-check

Am I a woman (postmenopausal, or premenopausal/perimenopausal and willing to take LHRH agonist) or a man (willing to take LHRH agonist)?
Do I have advanced or metastatic breast cancer that is ER-positive and HER2-negative?
Has my cancer continued to grow after one or two previous treatments for advanced cancer?
Am I generally well enough to participate in a study?
Am I not pregnant or breastfeeding?

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 would be randomly assigned to either receive the new drug giredestrant or one of the standard hormone treatments chosen by your doctor. This is like flipping a coin for treatment assignment. You won't know which treatment you are getting, and neither will your doctor, to ensure the results are fair.

You would have regular visits to the clinic for check-ups, blood tests, and scans (like CT or MRI) to see how you are responding to the treatment. These tests will help the doctors understand if the treatment is working and if there are any side effects. The medications would be given for as long as they are helping you and not causing serious side effects. The total length of your participation would depend on how your cancer responds to the treatment and your health, but you would be followed closely throughout.

For those who are premenopausal or perimenopausal, or men, an additional medication called an LHRH agonist would also be given throughout the study treatment period to help manage hormone levels.

Potential risks and benefits

Taking part in a clinical trial might offer benefits like access to a new treatment (giredestrant) before it's widely available, and you'll receive very close medical monitoring throughout the study. However, there's no guarantee the new treatment will work for you, and it might have side effects that are not yet fully known. The standard treatments also have their own set of potential side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (80)

Northwest Georgia Oncology Centers PC - Marietta
Marietta, United States
University Hospitals Seidman Cancer Center
Cleveland, United States
Northwest Cancer Specialists - Portland (SW Barnes Rd)
Tigard, United States
Instituto Angel Roffo
Buenos Aires, Argentina
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, Argentina
Fundación Scherbovsky
Mendoza, Argentina
Hosp Provincial D. Centenarios
Rosario, Argentina
Organizacion Medica de Investigacion
San Nicolás, Argentina
Kinghorn Cancer Centre
Darlinghurst, Australia
Sunshine Hospital
St Albans, Australia
Pronutrir - suporte nutricional e quimioterapia ltda.
Fortaleza, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Brazil

+68 more sites — see the official record for the full list.

Common questions

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

ER-positive means the breast cancer cells are encouraged to grow by the hormone oestrogen. HER2-negative means the cancer cells don't have too much of a protein called HER2, which is another common type of breast cancer.

What is giredestrant?

Giredestrant is a new type of drug being tested. It's designed to block the effects of oestrogen on cancer cells even more effectively than some current treatments.

What is an 'LHRH Agonist'?

An LHRH agonist is a medication that helps to reduce the amount of oestrogen made in the body, particularly for premenopausal women or men, to help manage hormone levels related to breast cancer.

Why is this study only for people whose cancer has been 'previously treated'?

The study is looking for new options where existing treatments haven't fully stopped the cancer. It helps researchers understand how giredestrant works when initial treatments are no longer effective.

What is a 'Phase 2' study?

A Phase 2 study is an early but important stage of research where doctors learn more about the safety of a new drug and how well it works for a specific condition, before potentially moving to larger studies.