A Randomized, Open-label, Multi-center Phase III Study Comparing the Efficacy of Oral Chemotherapy Combined With Trastuzumab Versus Paclitaxel Combined With Trastuzumab in the Adjuvant Treatment of HER2-positive, Lymph Node-negative Early Breast Cancer Patients(ORCHID-PLUS)

Although there is a certain risk of recurrence of HER2-positive small tumors, the overall prognosis is relatively good. In order to further reduce the toxicity and side effects of treatment and explore the best strategy for adjuvant therapy in patients with HER2-positive stage IA breast cancer, we designed this phase III, randomized, open-label study to evaluate the efficacy and safety of paclitaxel plus trastuzumab and capecitabine versus paclitaxel plus trastuzumab in the adjuvant treatment of patients with HER2-positive, node-negative breast cancer.

Trial Details

NCT ID
NCT06992882
Phase
PHASE3
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Capecitabine
  • Paclitaxel
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Females aged 18\~70;
  • The postoperative pathological stage of early breast cancer is stage IA: the longest diameter of invasive cancer is not more than 2cm and the lymph…
  • Pathological immunohistochemistry must meet the following conditions: HER-2 (3) or HER-2 (0-2) but amplified by FISH or CISH testing.
  • The maximum number of weeks (56 days) from surgery to randomization is not more than 8 weeks (56 days).

For full eligibility, visit ClinicalTrials.gov.

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