Phase 3 Breast Cancer Trial, RecruitingNCT06065748Sponsor: Hoffmann-La RocheCondition: Breast Cancer
Printed from Voxsanity (voxsanity.com.au) — NCT06065748 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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 might be able to join this trial:
You have breast cancer that has spread locally or to other parts of the body, and it cannot be cured with current treatments
Your tumor has tested positive for estrogen receptors (ER+) and negative for a protein called HER2 (HER2−), based on a recent or archived tissue sample
You have had a blood test (through the trial's central lab) to check for a specific gene change called an ESR1 mutation
Your cancer came back or grew while on, or within 12 months of finishing, a standard hormone-blocking therapy given after your original diagnosis
You have not yet received any systemic (whole-body) treatment for your advanced or metastatic breast cancer
Your cancer can be measured on scans, or you have disease in bones only (even if not easily measured)
You are fairly active and able to carry out daily activities with little or no limitation (confirm with trial site)
If you are a woman who has not yet gone through menopause, or if you are a man, you must be willing to receive and continue a specific hormone-suppressing injection throughout the trial
Who may not be able to join:
You have already received chemotherapy, immunotherapy, or other systemic cancer treatments for your advanced or metastatic breast cancer
You have previously been treated with certain hormone-blocking drugs called SERDs (such as fulvestrant) or similar newer estrogen-targeting therapies
Your cancer has spread to internal organs in a way that is causing serious symptoms and could become life-threatening in the near future
You have a currently active heart condition or a significant history of heart problems
You have a significant history of serious liver disease
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Northern Beaches Hospital, Frenchs Forest, New South Wales
Nepean Hospital, Kingswood, New South Wales
Mater Hospital, North Sydney, New South Wales
Sunshine Coast Haematology and Oncology Clinic, Buderim, Queensland
Mater Misericordiae Limited, South Brisbane, Queensland
Cancer Research SA, Adelaide, South Australia
Barwon Health, Geelong, Victoria
Sunshine Hospital, St Albans, Victoria
South West Healthcare, Warrnambool, Victoria
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT06065748
Sponsor: Hoffmann-La Roche
Phase: Phase 3
Status: Recruiting
Condition: Breast Cancer
Trial contact: 888-662-6728 (U.S. Only)
More information: https://clinicaltrials.gov/study/NCT06065748
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
You have breast cancer that has spread locally or to other parts of the body, and it cannot be cured with current treatments
Your tumor has tested positive for estrogen receptors (ER+) and negative for a protein called HER2 (HER2−), based on a recent or archived tissue sample
You have had a blood test (through the trial's central lab) to check for a specific gene change called an ESR1 mutation
Your cancer came back or grew while on, or within 12 months of finishing, a standard hormone-blocking therapy given after your original diagnosis
You have not yet received any systemic (whole-body) treatment for your advanced or metastatic breast cancer
Your cancer can be measured on scans, or you have disease in bones only (even if not easily measured)
You are fairly active and able to carry out daily activities with little or no limitation (confirm with trial site)
If you are a woman who has not yet gone through menopause, or if you are a man, you must be willing to receive and continue a specific hormone-suppressing injection throughout the trial
Who may not be able to join:
You have already received chemotherapy, immunotherapy, or other systemic cancer treatments for your advanced or metastatic breast cancer
You have previously been treated with certain hormone-blocking drugs called SERDs (such as fulvestrant) or similar newer estrogen-targeting therapies
Your cancer has spread to internal organs in a way that is causing serious symptoms and could become life-threatening in the near future
You have a currently active heart condition or a significant history of heart problems
You have a significant history of serious liver disease
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 21 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇷 Brazil
🇨🇦 Canada
🇨🇱 Chile
🇨🇳 China
🇨🇴 Colombia
Costa Rica
🇫🇮 Finland
🇫🇷 France
🇩🇪 Germany
🇬🇷 Greece
Guatemala
Hong Kong
🇭🇺 Hungary
🇮🇳 India
🇮🇱 Israel
🇮🇹 Italy
Kenya
🇲🇽 Mexico
🇳🇿 New Zealand
🇵🇪 Peru
🇵🇱 Poland
🇵🇹 Portugal
Puerto Rico
🇷🇴 Romania
🇸🇬 Singapore
🇸🇮 Slovenia
🇿🇦 South Africa
🇰🇷 South Korea
🇪🇸 Spain
🇹🇼 Taiwan
🇹🇭 Thailand
Turkey (Türkiye)
🇺🇸 United States
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup; PFS in the Full Analysis Set (FAS) Population
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.