Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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Study Matches
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.
Participants (females, regardless of menopausal status, and males) who are age 18 years at the time of signing the Informed Consent Form 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
Exclusion Criteria:
Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 9 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of TPC 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