RecruitingPhase IIFemale onlyEN originalBreast cancerHER2 positiveEarly / localized

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

⚠️

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

For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with stage I HER2-positive breast cancer and has confirmed the efficacy and safety of intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients enrolled in microinvasion are enrolled, and there is a lack of large sample size data to provide a treatment reference for these patients. In order to further explore the optimal strategy for adjuvant therapy in this type of patient, we designed a new clinical trial to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant therapy in previous retrospective studies.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjentki w wieku 18-70 lat.
  • Rak piersi we wczesnym stadium, po operacji, bez nacieku większego niż 1 mm i bez zajętych węzłów chłonnych.
  • Rak piersi potwierdzony jako HER2-dodatni.
  • Pacjentki, których organizm jest w dobrej kondycji ogólnej.

✗ Disqualifies

  • Rak piersi z naciekiem większym niż 1 mm lub z zajętymi węzłami chłonnymi.
  • Rak piersi HER2-ujemny.
  • Pacjentki, które przed badaniem otrzymywały inne leczenie niż operacja (np. chemioterapię, radioterapię).
  • Pacjentki z historią innych nowotworów w ciągu ostatnich 5 lat (z pewnymi wyjątkami).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
70 Years
Last updated (source)
March 22, 2024
Sex
Female only

Therapies / drugs in trial

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, 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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