Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab

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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

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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