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A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER (PSCI# 20-133) (GO42784)
The purpose of this study is to compare the effects, good or bad, of giredestrant versus an approved endocrine therapy (a treatment that blocks or removes hormones), on patients with breast cancer. In this study, subjects will get either giredestrant or a drug chosen specifically by the study doctor. Subjects can participate in this study based on breast cancer characteristics, current condition, and how well previous anti-cancer therapies were tolerated.
• You should not join another research study.• For women: If you can become pregnant, you must use a reliable non-hormonal birth control method during the study and for 9 days after your final dose of giredestrant or, if you are in the group receiving approved endocrine therapy prescribed by the study doctor, a period of time that your study doctor will discuss with you. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 60 days after if you are prescribed tamoxifen. Talk with your study doctor about what birth control method may be best for you. Depending on the study treatment you receive, you might be restricted from donating eggs during this same period. Tell your study doctor right away if you get pregnant during this period. If you get pregnant, the study doctor will want to follow up with you on the outcome of the pregnancy and collect information on the baby.• For men: you must agree to take precautions as outlined below for each treatment arm:–If you are in the group receiving approved endocrine therapy prescribed by the study doctor, you study doctor will discuss with you what precautions you will need to take.–If you are in the group receiving giredestrant, and your partner is pregnant or able to become pregnant, you must use a condom during the study and for 9 days after your final dose of giredestrant. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 90 days after if you are prescribed tamoxifen. You must not donate sperm during this same period. Tell your study doctor right away if your partner becomes pregnant during these periods. The study doctor or research staff will advise you of the possible risks to your unborn child and will make an effort to contact your partner to get her permission to collect information about the pregnancy and the baby. No matter what your partner decides, you can continue to take part in this study.• You should not use certain medications during this study. Your study doctor will talk to you about these medications.
Participants who have documented ER+ tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as 1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines
Participants who have documented HER2- tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines
Participants must have undergone definitive surgery of the primary breast tumor(s)
Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization
Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research
Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
Participants who have active cardiac disease or history of cardiac dysfunction
Participants who have been diagnosed with Stage IV breast cancer