Phase 3 Breast Cancer Trial, Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are considered appropriate for treatment with a type of hormone therapy called endocrine therapy.
- People who have been diagnosed with early breast cancer that has been confirmed by a tissue test, is hormone receptor-positive (ER+), HER2-negative, and is Stage I, II, or III.
- People whose tumour has been tested and shows ER+ results, meaning at least 1% of tumour cells tested positive, according to recognised testing guidelines.
- People whose tumour has been tested and confirmed as HER2-negative according to recognised testing guidelines.
- Women who are postmenopausal at the time of signing the consent form to join the trial.
- People who have a record of previously taking a type of hormone therapy called an aromatase inhibitor (AI) — such as anastrozole, exemestane, or letrozole — for a total of at least 6 months.
- People who have been taking an aromatase inhibitor (anastrozole, exemestane, or letrozole) continuously for at least the 3 months immediately before giving consent to join the trial.
- People where both the patient and their doctor agree that the side effects of the current aromatase inhibitor are too difficult to tolerate and that switching to a different therapy is warranted to help continue treatment.
- People who have documented moderate or severe side effects (Grade 2 or 3 as rated by a standard medical scale) that the doctor has determined are caused by the aromatase inhibitor.
- People who have not previously switched from one aromatase inhibitor to another — this would be their first such switch.
- People who have already completed all relevant prior treatments, which may include chemotherapy before or after surgery, surgery to remove the breast tumour and/or lymph nodes, and/or radiotherapy.
- People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have participated in another clinical trial involving an investigational cancer treatment within the 6 months before enrolling in this trial.
- People who have been diagnosed with rheumatoid arthritis, psoriatic arthritis, or another inflammatory connective tissue disease.
- People who have previously taken fulvestrant or any oral medication from a class of drugs called selective estrogen receptor degraders (SERDs).
- People who have active heart disease or a history of heart problems.
- People who have significant liver disease, including conditions rated as Child-Pugh Class B or C, active hepatitis B or C infection, current alcohol misuse, cirrhosis, or a positive test for viral hepatitis (confirm with trial site).
- People who have taken certain medications that strongly affect how the body processes drugs (known as strong CYP3A inhibitors or inducers) within 14 days or 5 drug elimination half-lives before starting the study treatment, whichever is the longer period (confirm with trial site).
- People who have a serious medical condition or abnormal laboratory test results that, in the doctor's judgement, would make it unsafe for them to participate in and complete the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Trials, Genentech, Inc.
Phone: 888-662-6728 (U.S. Only)
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Primary endpoints
Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months; Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.