Phase 2 Breast Cancer Trial, Recruiting NCT07102381 Sponsor: Jazz Pharmaceuticals Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT07102381
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 Stage II or III breast cancer that has been confirmed by a tissue biopsy.
  • Your breast cancer has been confirmed to be HER2-positive (a specific type of breast cancer identified through testing).
  • The hormone receptor (HR) status of your breast cancer tumor has been tested and is known.
  • If you have breast cancer in more than one area of the breast, you may still be eligible if the largest tumor is at least 2 cm wide, is HER2-positive, and your doctor has decided to treat it as HER2-positive.
  • You are willing to have surgery (either full breast removal or a smaller, breast-saving surgery) after receiving treatment before surgery.
  • You are generally able to carry out daily activities with little to no limitations (confirm with trial site).
  • Your major organs (such as liver and kidneys) are working well enough as shown by recent blood tests.
  • Your heart is pumping blood effectively — at least 50% efficiency — confirmed by a heart scan done within 4 weeks before starting the trial.
  • You are using adequate birth control methods if applicable.

Who may not be able to join:

  • Your breast cancer has spread to other parts of the body (Stage IV/metastatic).
  • You have cancer in both breasts at the same time.
  • You have a serious or uncontrolled health condition that the trial doctor feels could affect your participation.
  • You have high blood pressure that is not well controlled.
  • You have significant nerve problems in your hands or feet (such as numbness, tingling, or pain).
  • You currently have an active infection that is not under control.
  • You have previously had a severe, life-threatening allergic reaction to certain types of drugs similar to those used in this trial, including monoclonal antibodies or related proteins.
  • You have an active hepatitis B or hepatitis C infection.
  • You have been diagnosed with another cancer within the last 5 years (some exceptions apply, such as certain treated skin cancers — confirm with trial site).
  • You have previously received chemotherapy, anti-HER2 treatment, radiation, hormone therapy, or experimental treatment for invasive breast cancer.
  • You are planning to take part in another clinical trial or receive any other cancer treatment not included in this study's plan.
  • You have received a live vaccine within the 4 weeks before enrolling in the trial.
  • You have a known allergy to any of the medications used in this trial, including chemotherapy drugs.

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 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
Sponsor
Jazz Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
24 September 2025
Est. completion
1 January 2028

Where this trial is recruiting

🇮🇹 Italy 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Number of participants with pCR

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