Phase 3 Breast Cancer Trial, Recruiting NCT05827081 Sponsor: Novartis Pharmaceuticals Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT05827081
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:

  • Adults aged 18 or older at the time of signing the consent form
  • People who have been confirmed, through a tissue sample tested by a local lab, to have breast cancer that is estrogen-receptor positive and/or progesterone receptor positive
  • People whose breast cancer has tested negative for HER2 (a specific protein), based on standard lab testing methods on the most recently analysed tissue sample
  • People who have already started standard hormone-blocking therapy (such as tamoxifen or toremifene) before joining, as long as they started it no more than 36 months ago and still have at least 3 years of that treatment remaining
  • People who have had surgery where the tumour was completely removed, with no cancer cells found at the edges of the removed tissue, and whose cancer falls into a specific stage category (Stage IIB, a subset of Stage IIA, or Stage III — confirm exact staging eligibility with the trial site)
  • People with a general health/activity level rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, with or without some limitations)
  • People with adequate bone marrow and organ function, as assessed by the trial team
  • People whose heart electrical activity readings (from an ECG) fall within acceptable ranges — specifically, a certain heart rhythm measurement below 450 milliseconds and a resting heart rate between 50 and 99 beats per minute

Who may not be able to join:

  • People whose breast cancer has spread to distant parts of the body (Stage IV), or who have had their cancer return after surgery
  • People currently receiving other cancer treatments, apart from hormone-blocking therapy
  • People with other serious or poorly controlled health conditions that, in the doctor's judgement, could make participation unsafe, interfere with the study, or where life expectancy is estimated at 5 years or less
  • People with significant, uncontrolled heart disease or abnormal heart rhythm
  • People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial
  • Women who are physically capable of becoming pregnant, unless highly effective contraception is used throughout the treatment period and for 21 days after stopping the study treatment

Note: Other eligibility criteria not listed here may also apply.

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 23 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: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Phone: 1-888-669-6682

Australian sites

Novartis Investigative Site, Gateshead, New South Wales
Novartis Investigative Site, Tiwi, Northern Territory
Novartis Investigative Site, Clayton, Victoria
Novartis Investigative Site, East Melbourne, 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
28 February 2024
Est. completion
7 September 2029

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇩🇪 Germany Hong Kong 🇮🇳 India 🇮🇱 Israel 🇲🇽 Mexico 🇵🇹 Portugal Puerto Rico 🇰🇷 South Korea 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇸 United States

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

Primary endpoints

Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years

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: 23 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