New combo shot aims to stop early breast cancer from returning
NCT ID NCT04569747
First seen Sep 30, 2025 · Last updated Jun 22, 2026 · Updated 32 times
Summary
This Phase 2 trial is testing whether a combination of two targeted drugs (trastuzumab and pertuzumab) given as a single shot under the skin, along with standard hormone therapy, can prevent cancer from returning after surgery in people with early-stage, hormone receptor-positive, HER2-positive breast cancer. The study enrolls 393 participants with small tumors that have not spread to lymph nodes or have only microscopic spread. The main goal is to see how many people remain cancer-free three years after treatment.
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Cape Cod Healthcare Center
Hyannis, Massachusetts, 02601, United States
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Dana Farber Cancer Institite
Boston, Massachusetts, 02115, United States
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Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts, 02035, United States
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Dana-Farber Cancer Insitute at Londonderry Hospital
Londonderry, New Hampshire, 03053, United States
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Dana-Farber at Milford
Milford, Massachusetts, 01757, United States
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Dana-Farber at South Shore Hospital
Weymouth, Massachusetts, 02190, United States
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Eastern Maine Medical Center (Northern Light)
Brewer, Maine, 04412, United States
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Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Greco-Hainsworth Centers for Research/Tennessee Oncology
Nashville, Tennessee, 37203, United States
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Indiana University Health - Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
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Indiana University Health Schwarz Cancer Center
Indianapolis, Indiana, 46032, United States
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Indiana University Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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New York University Langone Health
New York, New York, 10016, United States
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New York University Langone Hospital - Long Island
Mineola, New York, 11501, United States
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New York University Langone Hospital -Brooklyn
Brooklyn, New York, 11220, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
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Stamford Hospital
Stamford, Connecticut, 06904, United States
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The Christ Hospital
Cincinnati, Ohio, 45219, United States
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UNC Rex Cancer Center
Raleigh, North Carolina, 27607, United States
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UNC Rex Cancer Center at Wakefield
Raleigh, North Carolina, 27614, United States
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UNC Rex Hematology Oncology Associated - Cary
Cary, North Carolina, 27518, United States
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UNC Rex Hematology Oncology Associates of Garner
Garner, North Carolina, 27529, United States
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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University of Miami- Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
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Winship Cancer Institute at Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
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Winship Cancer Institute at Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Trastuzumab and pertuzumab (given as a combined injection under the skin) plus hormone therapy (letrozole, anastrozole, exemestane, tamoxifen, or leuprolide)
What this could lead to
If successful, this could offer a more effective and convenient treatment option after surgery for people with early-stage HER2-positive breast cancer, potentially reducing the chance of the cancer coming back.
What could go wrong
This is a single-arm Phase 2 trial, so results are compared to historical data, not a placebo group. The long-term benefits and risks are still being studied, and the treatment may not work for everyone.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.