Phase 2 Breast Cancer Trial, Recruiting NCT06797635 Sponsor: Merck Sharp & Dohme LLC Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06797635
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 locally advanced breast cancer that has not spread to other parts of the body, with a tumor and lymph node involvement that falls within certain specific size and spread categories (confirm with trial site)
  • Your breast cancer has been confirmed by a central lab to be either "triple-negative" or a specific low-hormone type that will be treated like triple-negative breast cancer
  • If you have Hepatitis B, you may still be eligible if you have been on antiviral treatment for at least 4 weeks and the virus is undetectable in your blood
  • If you have a history of Hepatitis C, you may still be eligible if the virus is currently undetectable in your blood
  • You are generally well enough to carry out light activity and care for yourself (a standard health rating of 0 or 1 on a medical scale), assessed within the last 28 days
  • Your heart is pumping blood effectively, with a pumping function of 50% or above, confirmed by a heart scan

Who may not be able to join:

  • You have serious or poorly controlled heart disease
  • You have, or have had, cancer that has spread to the lining around the brain or spinal cord
  • You have a significant eye or cornea condition
  • You have HIV along with a history of a specific HIV-related cancer (Kaposi sarcoma) or a rare immune system disorder (multicentric Castleman disease)
  • You have an ongoing, uncontrolled infection caused by bacteria, fungus, or a virus
  • You have previously been treated with certain immunotherapy drugs that target the immune system's "checkpoint" pathways (such as anti-PD-1 or anti-PD-L1 therapies)
  • You have received any prior treatment for your current breast cancer diagnosis, including radiation, drug therapy, or surgery
  • You have previously been treated with certain targeted antibody drugs or a specific type of antibody-drug combination therapy (confirm with trial site)
  • Your breast cancer has spread to other parts of the body (Stage IV) or has spread to certain higher-level lymph nodes (confirm with trial site)
  • You have another cancer that is still active or has required treatment within the last 5 years
  • You have cancer that has spread to your brain or the fluid around your brain or spinal cord
  • You have ever had a lung condition called interstitial lung disease or pneumonitis, or are currently suspected of having it
  • You currently have an active infection that requires treatment with medication
  • You have both Hepatitis B and Hepatitis C infections at the same time
  • You have serious breathing difficulties caused by a current lung illness

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 30 June 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
20 March 2025
Est. completion
31 December 2029

Where this trial is recruiting

🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Part 1: Number of Participants Experiencing an Adverse Event (AE); Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs); Part 1: Number of Participants who Discontinued Study Treatment Due to an AE; Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0; Part 2: Number of Participants Experiencing an AE; Part 2: Number of Participants who Discontinued Study Treatment 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: 30 June 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