lidERA Breast Cancer Trial for Early-Stage Breast Cancer
Updated on September 12, 2025
Trial Details
Overview: The lidERA Breast Cancer trial comparing the effectiveness and safety of a new medicine – giredestrant – to doctors’ choice of hormonal therapy after surgery for people diagnosed with early-stage, estrogen receptor-positive, HER2-negative breast cancer.
Phase: Phase III; Phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large – some involve thousands of people – and are done at many places in the United States and around the world.
Number of people to enroll: This trial is active, but is no longer recruiting participants.
ClinicalTrials.gov ID number: NCT04961996
Sponsor of the trial: Hoffmann-La Roche
Who is the trial for?
The lidERA Breast Cancer trial is enrolling people diagnosed with stage I, stage II, and stage III (early-stage) hormone receptor-positive, HER-negative breast cancer with a medium and high risk of recurrence (the cancer coming back).
People in the study must have had surgery to remove the breast cancer and also had axillary or sentinel lymph node biopsy.
Why is the trial being done?
The trial is designed to see if a new experimental medicine, giredestrant, reduces the risk of recurrence of hormone receptor-positive breast cancer more than doctors’ choice of hormonal therapy medicine after surgery.
Giredestrant is a type of hormonal therapy medicine called a selective estrogen receptor downregulator (SERD). SERDs block the effect of estrogen on hormone receptor-positive breast cancer cells by sitting in the receptors so the estrogen can’t. SERDs also lower the number of estrogen receptors and change the shape of the receptors so they don’t work as well.
Currently, there are two SERDs used to treat breast cancer: Faslodex (chemical name: fulvestrant) and Orserdu (chemical name: elacestrant). But both of these SERDs are used to treat advanced-stage, hormone receptor-positive breast cancer.
Researchers want to know if taking giredestrant after surgery to remove hormone receptor-positive, early-stage breast cancer can reduce the risk of recurrence more than the current hormonal therapy medicines used for that purpose.
In the study, people will receive either:
Giredestrant: People will take a 30-milligram tablet of giredestrant once a day for 28 days (this is one cycle of treatment) for five years, or until the cancer recurs or they develop unacceptable side effects. Women who are pre- and peri-menopausal, as well as men, also will receive a luteinizing hormone-releasing hormone (LHRH) to reduce the amount of estrogen and testosterone in the body.
Their doctor’s choice of either tamoxifen or an aromatase inhibitor: People will take either tamoxifen or one of the three aromatase inhibitors — Arimidex (chemical name: anastrozole), Aromasin (chemical name: exemestane), or Femara (chemical name: letrozole) — once a day for 28 days (this is one cycle of treatment) for five years, or until the cancer recurs or they develop unacceptable side effects. Women who are pre- and peri-menopausal, as well as men, also will receive a luteinizing hormone-releasing hormone (LHRH) to reduce the amount of estrogen and testosterone in the body.
Specific eligibility requirements
People are eligible for the lidERA Breast Cancer study if they:
have been diagnosed with early-stage, hormone receptor-positive, HER-negative breast cancer
have had surgery to remove the breast cancer, as well as either axillary or sentinel lymph node biopsy, no more than 12 months before joining the study
if people have received chemotherapy, at least 21 days must have passed between the last chemotherapy dose and joining the study
are able to swallow oral medicine
People are not eligible for the lidERA Breast Cancer study if they:
are pregnant or breastfeeding
have received or are planning to receive a CDK4/6 inhibitor: Ibrance (chemical name: palbociclib), Kisqali (chemical name: ribociclib), or Verzenio (chemical name: abemaciclib), though a short course of up to 12 weeks of a CDK4/6 inhibitor is allowed
have heart disease or a history of heart dysfunction
have been diagnosed with stage IV breast cancer
have received any other hormonal therapy medicine before, though a short course of up to 12 weeks of hormonal therapy is allowed
Possible side effects of giredestrant
Because giredestrant is a new medicine, we may not know all its side effects. In earlier studies, the most common side effects of giredestrant were:
Possible side effects of the other hormonal therapy medicines in the study
The most common side effects of tamoxifen are:
The most common side effects of the aromatase inhibitors are:
arthritis
broken bones
Study locations
The lidERA Breast Cancer study is being conducted in a number of sites across the United States, as well as in Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czechia, Finland, France, Georgia, Germany, Greece, Guatemala, Hon Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Malaysia, Mexico, the Netherlands, North Macedonia, Peru, the Philippines, Poland, Portugal, Romania, the Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, the United Kingdom, and Vietnam.
For more information or to enroll
In the United States, you can call Roche at 1-888-662-6728. Anyone can email global-roche-genentech-trials@gene.com.