Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

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 opt

Trial Details

NCT ID
NCT05861271
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Capecitabine，Pyrotinib
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Women aged 18-70;
  • The pathology of early breast cancer after surgery is T1micN0: histologically confirmed that the longest diameter of invasive cancer does not excee…
  • The pathological type of immunohistochemistry needs to meet the following conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection.
  • Hormone receptor negative (HR-) is defined as ER, PR expression is \<1%; Hormone receptor positivity (HR+) is defined as ER and/or PR expression ≥1%.

For full eligibility, visit ClinicalTrials.gov.

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