Phase 3 study for people with Breast Cancer
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Clinical Trial Site | Sydney | NSW | Recruiting |
| Clinical Trial Site | Waratah | NSW | Recruiting |
| Clinical Trial Site | South Brisbane | QLD | Recruiting |
| Clinical Trial Site | Adelaide | SA | Recruiting |
| Clinical Trial Site | Clayton | VIC | Terminated |
| Clinical Trial Site | Geelong | VIC | Recruiting |
| Clinical Trial Site | Heidelberg | VIC | Recruiting |
| Clinical Trial Site | Nedlands | WA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* Adult female or male participants.
* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
* Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
* De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, hepatic, and renal functions.
* Female participants can be pre-, peri- or postmenopausal.
* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
Exclusion Criteria:
* Disease recurrence during adjuvant endocrine therapy
* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
* History of allergic reactions to study treatment.
* Any contraindications to letrozole and ribociclib.
* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 23 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.