Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally Advanced/Metastatic Breast Cancer

Documented ER-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Allison et al 2020), defined as ≥1% of tumor cells stained positive, as documented through local laboratory testing of a primary disease specimen

Documented HER2-negative tumor according to ASCO/CAP guidelines (Wolff et al. 2023), as documented through local laboratory testing of a primary disease specimen

Adequate hematologic and organ function at screening

Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to CTCAE v6.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, or other toxicities not considered a safety risk for the participant per treating physician's judgment)