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NCT05774951

NCT05774951
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are a man or woman aged 18 or older at the time of screening (or meet the age requirement based on your country's guidelines)
  • You have been diagnosed with a specific type of early-stage breast cancer (ER-positive, HER2-negative) that has been confirmed by a tissue sample, and your doctors have assessed it as having an intermediate or high chance of coming back
  • You have already completed your main local treatment for the breast tumour, such as surgery, with or without radiation therapy, and with or without chemotherapy given before or after surgery
  • You have been taking hormone-blocking therapy (and possibly an additional targeted medicine) for at least 2 years but no more than 5 years and 3 months
  • You are generally well enough to carry out light activity and care for yourself (confirm with trial site)
  • Your kidneys, liver, and other organs are working well enough to participate (confirm with trial site)

Who may not be able to join:

  • Your breast cancer has spread to other parts of the body or cannot be removed by surgery
  • Your breast cancer completely disappeared after treatment given before surgery (called a pathological complete response)
  • You have had another type of cancer in the past, unless it was a minor skin cancer, early-stage cervical cell changes, or you have been cancer-free without any treatment for at least 5 years
  • You have another serious or poorly controlled illness that the trial doctor believes would make participation unsafe or difficult
  • You have a known weakened heart function or moderate-to-severe heart failure (confirm with trial site)
  • A specific measurement of your heart's electrical activity (QTcF interval) was above a certain level at screening (confirm with trial site)
  • You are currently taking any external hormone therapy (such as hormone replacement therapy)
  • You are currently receiving any other cancer treatment not allowed by the trial, with the exception of certain bone-strengthening medicines
  • You have previously been treated with camizestrant (the trial drug), fulvestrant, or similar experimental hormone-targeting drugs
  • You are currently pregnant or breastfeeding
  • You have a known allergy to camizestrant or medicines with a similar make-up, or — if you are a pre/peri-menopausal woman or a man — a known allergy or intolerance to a type of hormone-suppressing injection that may be required as part of the trial (confirm with trial site)

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.

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.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
AstraZeneca
Registry
clinicaltrials_gov
Start date
31 March 2023
Est. completion
20 April 2027

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇨🇿 Czechia 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇪 Peru 🇵🇭 Philippines 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇸 Serbia 🇸🇬 Singapore 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States 🇻🇳 Vietnam

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Invasive breast cancer-free survival (IBCFS)

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov