Phase 2 Breast Cancer Trial, Recruiting NCT06686394 Sponsor: Merck Sharp & Dohme LLC Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06686394
Recruiting Phase 2

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 HER2-positive breast cancer that has either spread to other parts of the body or cannot be removed with surgery
  • If you have HIV, it must be well-controlled with HIV medication
  • If you have hepatitis B, you must have been on hepatitis B antiviral treatment for at least 4 weeks and have no detectable virus in your blood
  • If you have a history of hepatitis C, the virus must be undetectable in your blood
  • You must be generally healthy enough to carry out normal daily activities with little to no limitation (confirm with trial site)
  • Group 1 only: You have received between 2 and 5 previous HER2-targeted treatments for advanced or metastatic disease, and your cancer got worse during or after treatment with a specific drug called trastuzumab deruxtecan (T-DXd)
  • Group 2 only: You have received no more than 5 previous HER2-targeted treatments for advanced or metastatic disease
  • Group 3 only: Your cancer got worse during or after treatment with T-DXd (in any setting), you have had no more than 3 prior HER2-targeted treatments for advanced or metastatic disease, and T-DXd was the last treatment you received before joining the trial

Who may not be able to join:

  • You have serious or uncontrolled heart disease
  • You have had lung inflammation (not caused by infection) that needed steroid treatment, or you currently have lung inflammation
  • You have serious breathing difficulties
  • You have or have had cancer that has spread to the membranes surrounding the brain or spinal cord
  • You have a significant eye/cornea condition
  • You have an ongoing infection (bacterial, fungal, or viral) that is not under control
  • You have HIV and also have a history of Kaposi's sarcoma or a condition called Multicentric Castleman's Disease
  • You have another cancer that is growing or has needed active treatment within the last 3 years
  • There is evidence that cancer has spread to your brain or is pressing on your spinal cord
  • You currently have an active infection that requires medication
  • You have both active hepatitis B and hepatitis C at the same time
  • You have had a major surgery within the last 28 days (not including placement of a drip line or port)
  • Group 3 only: You have previously been treated with tucatinib, lapatinib, neratinib, or any experimental HER2-targeted drugs of a similar type for advanced or metastatic 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 19 July 2026
Phase 2: approximately ~30% 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

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 2
Registry
ClinicalTrials.gov
Start date
26 February 2025
Est. completion
18 April 2030

Where this trial is recruiting

🇨🇦 Canada 🇮🇱 Israel 🇯🇵 Japan 🇰🇷 South Korea 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Number of Participants Experiencing Dose-Limiting Toxicity (DLT); Number of Participants with One or More Adverse Events (AEs); Number of Participants who Discontinue Study Intervention Due to an AE

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: 19 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