Expanded Access Program for Giredestrant in Patients with ER+, HER2- Breast Cancer

Inclusion Criteria

• Have a breast cancer tumor that is ER-positive, meaning at least 1% of the tumor cells test positive for estrogen receptors.
• Have a breast cancer tumor that is HER2-negative.
• Have good blood and organ function.
• Have recovered from any side effects of previous cancer treatments or surgeries to a mild level.
• Agree to use contraception if applicable.
• Women can be postmenopausal, premenopausal, or perimenopausal, with specific criteria for each.
• Premenopausal or perimenopausal women and men must agree to receive hormone therapy during the program.
• Be able to swallow pills whole.

Inclusion Criteria for Early Breast Cancer (eBC) Cohort:

• Be in good overall health with an ECOG performance status of 0-2.
• Have had surgery to remove the primary breast tumor and lymph nodes.
• If you had chemotherapy before surgery, it must have been within the last 12 months.
• If you had chemotherapy after surgery, it must be completed before joining the program, with a 21-day gap before starting the program.
• Have Stage I, II, or III breast cancer with a medium or high risk of coming back.

Inclusion Criteria for Locally Advanced/Metastatic Breast Cancer (LA/mBC) Cohort:

• Have locally advanced or metastatic breast cancer that cannot be cured with surgery.
• Be in good overall health with an ECOG performance status of 0-1.
• Have cancer that progressed after at least 6 months on hormone therapy plus a CDK4/6 inhibitor, or came back within 12 months of such treatment.
• Have a specific ESR1 gene mutation.

Exclusion Criteria

• Have previously participated in a study of giredestrant by Roche or Genentech.
• Are currently in or eligible for another giredestrant study by Roche or Genentech.
• Cannot follow the program procedures.
• Have taken certain medications that affect liver enzymes within 14 days before starting the program.
• Have had any investigational therapy within 28 days before starting the program.
• Have had major surgery, chemotherapy, or radiation within 21 days before starting the program.
• Have had another type of cancer within the last 3 years, except for certain low-risk cancers.
• Have active or uncontrolled cancer spread to the brain or spinal cord.
• Have serious heart disease or liver disease.
• Have lung disease or need oxygen therapy.
• Have a serious infection within 14 days before starting the program.
• Have any medical condition that makes participation unsafe.
• Are allergic to any of the program drugs.
• Are pregnant or breastfeeding, or plan to become pregnant during the program.

Exclusion Criteria for eBC Cohort:

• Are currently or planning to take CDK4/6 inhibitors as part of treatment.
• Have had more than 12 weeks of certain hormone treatments.

Exclusion Criteria for LA/mBC Cohort:

• Have had more than two prior hormone treatments for advanced breast cancer.
• Have had certain other hormone treatments or medications.
• Have advanced cancer spread that could cause life-threatening complications.
• Have HIV with certain conditions, such as low CD4 count or recent infections.
• Have digestive issues that affect medication absorption.