Phase 3 Breast Cancer Trial, Recruiting NCT07085767 Sponsor: Olema Pharmaceuticals, Inc. Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT07085767
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 of any gender are welcome to participate.
  • You have been diagnosed with breast cancer that is estrogen receptor positive (ER+) and HER2 negative (HER2-), and the cancer has either spread to other parts of the body or cannot be removed with surgery.
  • Your cancer can be measured or tracked through scans, or you have cancer that has spread only to the bones.
  • You were either diagnosed with advanced breast cancer from the start, or your cancer came back more than 12 months after you finished a course of hormone-based treatment (which may or may not have included a type of drug called a CDK4/6 inhibitor).
  • You are generally able to carry out daily activities with little or no limitation (confirm with trial site).
  • Your blood counts and kidney and liver function are within acceptable ranges.
  • Female participants can be at any stage of menopause — before, during, or after.
  • Men and women who have not yet fully gone through menopause must be willing to take a specific hormone-suppressing injection (called a GnRH or LHRH agonist).

Who may not be able to join:

  • Your cancer came back while you were still taking hormone-based treatment (rather than after finishing it).
  • You are currently receiving, or have previously received, any anti-cancer treatment specifically for this type of advanced breast cancer.
  • You have previously been treated with certain specific hormone therapies called fulvestrant, elacestrant, or any experimental hormone-based treatment.
  • You have a history of allergic reactions to any of the treatments used in this trial.
  • You have any medical reasons why you cannot safely take the drugs letrozole or ribociclib (confirm with trial site).
  • You have cancer that has spread to the brain or spinal cord and is currently causing symptoms that need immediate treatment.

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 2 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.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Olema Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
3 November 2025
Est. completion
1 December 2028

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇹 Italy 🇲🇾 Malaysia 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Progression-Free Survival (PFS)

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: 2 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