Phase 2 Breast Cancer Trial, Recruiting
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.
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
Where this trial is recruiting
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?
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.