Phase 3 Breast Cancer Trial, Recruiting NCT07060807 Sponsor: Merck Sharp & Dohme LLC Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT07060807
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 been diagnosed with a type of breast cancer that is hormone receptor positive (HR+) and HER2 negative, and the cancer has either spread to other parts of the body or is locally advanced and cannot be completely removed by surgery
  • Your cancer has been tested and confirmed through a biopsy (a tissue sample taken during or after your most recent treatment) to have certain specific characteristics related to hormone receptors, HER2, and a protein called HER3
  • Your cancer got worse or came back while you were being treated with a specific combination of drugs called a CDK4/6 inhibitor plus hormone therapy — either as your first treatment for advanced cancer, or during or within 2 years of finishing a similar combination given after surgery
  • Your cancer can be measured on scans using standard medical guidelines (confirm with trial site)
  • If you have HIV, it must be well controlled with medication
  • You are in good general health, able to carry out daily activities with little or no limitation, as assessed by your doctor within 7 days before joining the trial

Who may not be able to join:

  • Your breast cancer could potentially be cured with treatment
  • Your doctor believes you could still benefit from further hormone-based treatments for advanced disease
  • You carry a specific inherited gene change (BRCA mutation) where a type of drug called a PARP inhibitor could be used to treat you
  • Your cancer is causing or is about to cause serious, life-threatening problems with your internal organs
  • Your blood oxygen level at rest is below 92%, or you need oxygen support at any time
  • You have serious, uncontrolled heart or blood vessel disease
  • You have moderate or severe nerve damage causing numbness, tingling, or pain (Grade 2 or higher peripheral neuropathy)
  • You have a significant eye or cornea condition
  • You have previously received chemotherapy for advanced or metastatic breast cancer
  • You have previously been treated with a specific type of drug that targets the HER3 protein, or a drug combining an antibody with a chemotherapy agent that works in a similar way to the drug being studied in this trial
  • You have received cancer treatment too recently before joining the trial (within 4 weeks or 5 half-lives, whichever is shorter — though patients previously on hormone therapy plus a CDK4/6 inhibitor may qualify if at least 2 weeks have passed)
  • You have had radiotherapy to areas other than the brain within 14 days before starting the trial, or needed steroids because of radiation side effects in that time
  • You have a condition that weakens your immune system, or you regularly take steroid medications
  • You have another cancer that is active or has required treatment within the past 3 years
  • You have a history of lung inflammation (pneumonitis or interstitial lung disease) that needed steroids, or you currently have or may have this condition
  • You have had a severe allergic reaction to the study drug or any of its ingredients
  • You have had a severe allergic reaction to all of the alternative standard treatments used in this 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.

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 27 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: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Australian sites

Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 2300), Blacktown, New South Wales
02 8670 5077
Chris O'Brien Lifehouse ( Site 2302), Camperdown, New South Wales
+61 2 85140922
Monash Medical Centre ( Site 2301), Clayton, Victoria
+61 3 85722941
The Alfred Hospital ( Site 2305), Melbourne, Victoria
03 9076 2000
Sir Charles Gairdner Hospital ( Site 2304), Nedlands, Western Australia
08 6457 3333

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
21 July 2025
Est. completion
14 July 2033

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇵🇪 Peru 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States 🇻🇳 Vietnam

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

Primary endpoints

Progression Free Survival (PFS); Overall Survival (OS)

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: 27 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