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 |
|---|---|---|---|
| St Vincent's Hospital Sydney | Darlinghurst | NSW | Recruiting |
| Lake Macquarie Private Hospital - Oncology | Gateshead | NSW | Recruiting |
| St George Hospital - Medical Oncology | Kogarah | NSW | Recruiting |
| Lismore Base Hospital - Cancer Care , Haematology Unit | Lismore | NSW | Recruiting |
| Macquarie University | Macquarie Park | NSW | Recruiting |
| Mater Hospital Sydney | North Sydney | NSW | Recruiting |
| Westmead Hospital | Westmead | NSW | Recruiting |
| Icon Cancer Centre Wesley | Auchenflower | QLD | Recruiting |
| Icon Cancer Centre Townsville | Hyde Park | QLD | Recruiting |
| Icon Cancer Centre Southport | Southport | QLD | Recruiting |
| Cancer Research SA | Adelaide | SA | Recruiting |
| Royal Adelaide Hospital - Oncology | Adelaide | SA | Recruiting |
| Flinders Medical Centre | Bedford Park | SA | Recruiting |
| Icon Cancer Centre Kurralta Park | Kurralta Park | SA | Recruiting |
| The Queen Elizabeth Hospital | Woodville | SA | Recruiting |
| Launceston General Hospital - Medical Oncology | Launceston | TAS | Recruiting |
| Box Hill Hospital | Box Hill | VIC | Recruiting |
| Monash Medical Centre | Clayton | VIC | Recruiting |
| Northern Hospital | Epping | VIC | Recruiting |
| Maroondah Hospitals - Medical Oncology | Melbourne | VIC | Recruiting |
| Goulburn Valley Health | Shepparton | VIC | Recruiting |
| Breast Cancer Research Centre | Nedlands | WA | Recruiting |
| Austin Health | Heidelberg | VIC | Recruiting |
| Icon Cancer Centre Hobart | Hobart | TAS | Recruiting |
| Mid North Coast Cancer Institute | Port Macquarie | NSW | 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.
Key Inclusion Criteria:
* Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists guidelines.
* Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria:
1. ≥4 positive axillary lymph nodes or
2. 1-3 positive axillary lymph nodes and
1. Histologic grade 3 disease and/or
2. Tumor size ≥5 centimeters and/or
3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50)
* Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist.
* Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase inhibitor must have already completed or discontinued these treatments.
Key Exclusion Criteria:
* Participants with inflammatory breast cancer.
* History of any prior (ipsilateral and/or contralateral) invasive breast cancer.
* Participant with history of non-breast malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
* Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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: 15 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.