A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
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CONTACT
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer
Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy)
Participants must have completed any prior adjuvant chemotherapy before enrollment, if given
Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
Adequate organ function
Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist
You may not be if
Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
Diagnosis of inoperable locally advanced or Stage IV breast cancer
History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)
Planned surgery during the study
Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents
Active cardiac disease or history of cardiac dysfunction
Clareo Health | A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment