Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer following neoadjuvant therapy. Furthermore, there are no prospective randomized controlled trials comparing trastuzumab plus pertuzumab versus trastuzumab plus TKIs in HER2-positive breast cancer patients with residual cancer burden class (RCB) I or II after neoadjuvant trastuzumab and pertuzumab. Therefore, this study aimed to evaluate the efficacy and safety of adjuvant trastuzumab plus neratinib in patients with hormone receptor-positive/HER2-positive breast cancer and RCB 0/I following neoadjuvant trastuzumab and pertuzumab therapy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku 18-70 lat.
- •Choroba potwierdzona badaniami (rak piersi hormonozależny i HER2-dodatni).
- •Wcześniejsze leczenie wstępne (trastuzumab i pertuzumab) zakończone bez nawrotu.
- •Pozostałości guza po leczeniu wstępnym w określonej klasie (RCB 0 lub I).
- •Sprawność ogólna pozwalająca na udział w badaniu.
- •Prawidłowe wyniki badań krwi.
- •Serce pracuje prawidłowo (ocena EKG serca).
✗ Disqualifies
- •Nawrót raka piersi w przeszłości.
- •Rak piersi z przerzutami (stadium IV).
- •Inne, ciężkie choroby współistniejące.
- •Wcześniejsze przyjmowanie neratinibu.
- •Ciąża lub karmienie piersią.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- September 25, 2025
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Sun Yat-sen University Sun Yat-sen Memorial Hospital
Guangzhou, China
Trial contact
Chang Gong
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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