Pyrotinib in HER2-positive Early Breast Cancer

Sponsor
Nie Jianyun
Study ID
NCT06718335
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib — DRUG
    Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin.In adjuvant therapy, pathological complete response patients receive pyrotinib time to one year, non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine time to one year，RCB≥2 were treated with Trastuzumab Emtansine combined with pertuzumab time to one year.

Study Details

This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden (RCB) scores.

Key Dates

First listed
Dec 5, 2024
Start date
Dec 30, 2024
Status verified
Dec 2024
Primary completion
Dec 30, 2027
Completion
Dec 30, 2029

Study Design

Enrollment
156 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pyrotinib
    Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative pathological complete response patients receive pyrotinib (400mg, qd) for one year,. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators.
  • Experimental: T-DM1
    Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative non-pathological complete response patients with RCB-1 receive Trastuzumab Emtansine (3.6 mg/kg, iv) for one year. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators.
  • Experimental: T-DM1 and pertuzumab
    Patients who meet the screening criteria will receive pyrotinib (400mg, qd) + trastuzumab injection (first dose 8mg/kg, subsequent 6mg/kg, d1) + albumin purpurenin (125mg/m2, d1, d8) + carboplatin (AUC=6, d1) for 21 days/cycle for a total of 6 cycles of neoadjuvant therapy. One month after the end of neoadjuvant therapy, patients should receive radical mastectomy (breast-conserving surgery or total mastectomy), if the postoperative non-pathological complete response patients with RCB≥2 were treated with Trastuzumab Emtansine (3.6 mg/kg, iv) combined with pertuzumab for one year. If patients were hormone receptor positive patients at the adjuvant treatment stage, the endocrine treatment regimen was selected by the investigators.

Primary Outcome Measure

Event Free Survival(EFS) [ Time Frame: 3 year ]

Central Contacts

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