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New treatment option for Breast Cancer
Official title Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease
ClinicalTrials.gov ID: NCT05388149
What this study is testing
What is Neratinib?
Neratinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as NERLYNX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2 study for patients with resected Stage I-III HER2+ breast cancer with detected molecular residual disease (MRD+) following standard neoadjuvant and locoregional therapy delivered with curative intent. In this study Patients will be treated with neratinib in addition to their standard T-DM1 adjuvant therapy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients ≥ 18 years of age with histologically confirmed, resected HER2 positive stage I-III breast cancer, with residual invasive...
- Receiving adjuvant T-DM1, with evidence of MRD (positive test by Inivata RaDaR) after receiving 2-6 cycles of T-DM1
- No contraindications to T-DM1 or neratinib
- No clinical or radiographic evidence of recurrent or metastatic disease
- Previous Therapy requirements:
You likely can't join if
- Prior therapy with any HER2 tyrosine kinase inhibitor
- Clinical or radiographic evidence of suspected or confirmed metastatic disease.
- Previous or concurrent malignancy within 3 years of study entry, with exceptions
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Known positive serology for HIV that is not currently controlled with anti-retroviral therapy,
- 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...
See the full eligibility criteria
- 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...
- Receiving adjuvant T-DM1, with evidence of MRD (positive test by Inivata RaDaR) after receiving 2-6 cycles of T-DM1
- No contraindications to T-DM1 or neratinib
- No clinical or radiographic evidence of recurrent or metastatic disease
- 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
- ECOG performance status 0-1.
- Patient must have adequate organ function
- WOCBP must have a negative serum [beta] HCG test result.
- WOCBP must agree to use highly effective contraception
- Male participants must agree to use highly effective contraception
- 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.
- Signed informed consent
- Prior therapy with any HER2 tyrosine kinase inhibitor
- Clinical or radiographic evidence of suspected or confirmed metastatic disease.
- Previous or concurrent malignancy within 3 years of study entry, with exceptions
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Known positive serology for HIV that is not currently controlled with anti-retroviral therapy,
- 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...
- Impaired gastrointestinal function or disease that may significantly alter the absorption of neratinib
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.