New hope for breast cancer patients: extra targeted drug may clear remaining tumors
NCT ID NCT07589699
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding 4 cycles of the targeted drug trastuzumab rezetecan (T-DXh) can eliminate residual cancer in HER2-positive breast cancer patients who still have disease after standard chemotherapy. About 59 adults will receive the drug before surgery. The main goal is to see how many achieve a complete response (no cancer found in breast or lymph nodes).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trastuzumab rezetecan (T-DXh), a targeted drug that delivers chemotherapy directly to HER2-positive cancer cells
- What this could lead to
- If successful, this could offer a more effective neoadjuvant option for patients who don't fully respond to standard therapy, potentially reducing recurrence risk.
- What could go wrong
- This is a small, early-phase study (59 participants) without a control group, so results may not be generalizable. The drug can cause side effects like low blood counts or lung inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 59 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years. * For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period. * Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+). * Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR). * Agree to undergo a core needle biopsy. * ECOG performance status 0 or 1. * Adequate organ function meeting the following criteria: hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, absolute neutrophil count ≥ 1.5 × 10\^9/L, AST/ALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN. * No myocardial ischemia on ECG; New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥ 55% by echocardiography; cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) within normal limits. * Signed informed consent. Exclusion Criteria: * Male breast cancer or inflammatory breast cancer. * Metastatic breast cancer (Stage IV). * Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. * Concurrent other anti-tumor therapy or participation in another clinical trial. * Severe non-malignant disease that would affect compliance or place the patient at risk. * Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study. History of allergic reaction or contraindication to any component of the study drug. * Dementia, mental abnormality, or any psychiatric illness that interferes with understanding of the informed consent. * Any other condition assessed by the investigator as unsuitable for inclusion.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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