Phase 3 Breast Cancer Trial, Recruiting NCT06065748 Sponsor: Hoffmann-La Roche Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT06065748
Recruiting Phase 3 🇦🇺 Australian site

Who may 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 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

Phone: 888-662-6728 (U.S. Only)

Australian sites

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

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
11 December 2023
Est. completion
19 February 2027

Where this trial is recruiting

🇦🇷 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.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov