Can an added pill wipe out hidden breast cancer cells?
NCT ID NCT05388149
First seen Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time
Summary
Researchers are testing whether adding the oral drug neratinib to standard T-DM1 therapy can clear tiny amounts of remaining cancer DNA in people treated for early HER2-positive breast cancer. Participants have already had surgery and standard treatment, but sensitive blood tests still detect molecular residual disease, meaning traces of tumor DNA remain. The trial gives neratinib daily for up to a year alongside T-DM1 and tracks whether the residual disease disappears and whether cancer stays away.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- neratinib, an oral drug given alongside standard T-DM1 therapy
- What this could lead to
- If it works, adding neratinib could help clear lingering cancer DNA and lower the chance of HER2-positive breast cancer returning after treatment.
- What could go wrong
- This is a small Phase 2 trial with about 15 participants, so any signal may not hold in larger studies. Neratinib can cause significant diarrhea and other side effects, and the combination may not clear the residual disease.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Jul 2027
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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Anyone
- 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: 1. Male or female patients ≥ 18 years of age with histologically confirmed, resected HER2 positive stage I-III breast cancer, with residual invasive disease following prior neoadjuvant trastuzumab (+/- pertuzumab)-based chemotherapy. 2. Receiving adjuvant T-DM1, with evidence of MRD (positive test by Inivata RaDaR) after receiving 2-6 cycles of T-DM1 3. No contraindications to T-DM1 or neratinib 4. No clinical or radiographic evidence of recurrent or metastatic disease 5. Previous Therapy requirements: * Received 2-6 cycles of trastuzumab-DM1 in the adjuvant setting * Received min of 12 weeks of endocrine therapy (ER+ patients) * Adjuvant radiation permitted (minimum 14-day washout required) * No prior neratinib or other HER2 tyrosine kinase inhibitor 6. ECOG performance status 0-1. 7. Patient must have adequate organ function 8. WOCBP must have a negative serum \[beta\] HCG test result. 9. WOCBP must agree to use highly effective contraception 10. Male participants must agree to use highly effective contraception 11. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 12. Signed informed consent Exclusion Criteria: 1. Prior therapy with any HER2 tyrosine kinase inhibitor 2. Clinical or radiographic evidence of suspected or confirmed metastatic disease. 3. Previous or concurrent malignancy within 3 years of study entry, with exceptions 4. Impaired cardiovascular function or clinically significant cardiovascular diseases 5. Known positive serology for HIV that is not currently controlled with anti-retroviral therapy, 6. Has a known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (defined as HCV RNA \[qualitative\] is detected). HBV DNA must be undetectable and HBsAg negative at Screening Visit. Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at Screening Visit. 7. Impaired gastrointestinal function or disease that may significantly alter the absorption of neratinib 8. Medical, psychiatric, cognitive, or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol, or complete the study.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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University Health Network: Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 1Z5, Canada
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