This study was phase IB-II clinical trial that designed to evaluate the efficacy and safety of docetaxel + atezolizumab + Herceptin sc plus pertuzumab(TAHP) plus adjuvant therapy of atezolizumab + trastuzumab + pertuzumab(AHP) after surgery in female patients with HER2-positive early breast cancer. Adjuvant AHP (atezolizumab + Herceptin SC + pertuzumab) will be continued for remaining 1 year. For non-p CR patients, they are going to treat with 4 cycles of AC rather than Taxane only before AHP adjuvant therapy.
A, Neoadjuvant setting); 6 cycles q3weeks, intravenous(IV) administration * Docetaxel (75mg/m2, intravenous(IV)) Day(D)1 * Atezolizumab (1200mg, IV) D1 * Herceptin sc (600mg subcutaneous(SC))D1 * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg(IV))D1 B, Adjuvant setting : 11-12 cycles q3weeks \[patients with pCR\] * Atezolizumab (1200mg, IV) * Trastuzumab (600mg, SC) * Pertuzumab (420mg, IV) D1 \[patients with non-pCR\] * Doxorubicin(60mg/m2), cyclophosphamide (600mg/m2) D1 X 4cycles 3weeks * Atezolizumab (1200mg, IV) * Trastuzumab (600mg, SC) * Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks * Docetaxel (75mg/m2, IV) * Atezolizumab (1200mg, IV) * Tastuzumab (600mg, SC) * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : patients with pCR:D1 X 11-12 cycles, q3weeks * Atezolizumab (1200mg, IV) * Trastuzumab (600mg, SC) * Pertuzumab (420mg, IV)
(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks * Docetaxel (75mg/m2, IV) * Atezolizumab (1200mg, IV) * Tastuzumab (600mg, SC) * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : patients with non-pCR * Doxorubicin(60mg/m2) plus cyclophosphamide (600mg/m2) D1 X 4cycles q3weeks followed by * Atezolizumab (1200mg, IV), Trastuzumab (600mg, SC) and Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks
Samsung Medical Center
Seoul, South Korea
Pathologic CR(pCR) rate of neo-adjuvant chemotherapy
pCR rate of neoadjuvant chemotherapy with the patients with HER2+ EBC
Time frame: Pathologic Clinical response is perforemed after end of cycle 6 (each cycle is 21days).
Event free survival(EFS)
Event free survival of the patient with pCR vs. non-pCR
Time frame: 3 years
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