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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
B, Adjuvant setting : 11-12 cycles q3weeks [patients with pCR]
[patients with non-pCR]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pathologic Complete response | Experimental | (A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
(B, Adjuvant setting) : D1 X 11-12 cycles, q3weeks
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| non-pathologic Complete response | Experimental | (A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
(B, Adjuvant setting) :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAHP and AHP | Drug | (A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
(B, Adjuvant setting) : patients with pCR:D1 X 11-12 cycles, q3weeks
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic CR(pCR) rate of neo-adjuvant chemotherapy | pCR rate of neoadjuvant chemotherapy with the patients with HER2+ EBC | Pathologic Clinical response is perforemed after end of cycle 6 (each cycle is 21days). |
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival(EFS) | Event free survival of the patient with pCR vs. non-pCR | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events will be measured by the CTCAE scale, version 5.0 | safety and toxicity | 1 year |
Inclusion Criteria:
Patient is an adult, female ≥ 18 years old at the time of informed consent
Patient has histologically confirmed diagnosis of breast cancer
Patients with locally advanced breast cancer (T2-3N0-3)
Patients with early breast cancer with high-risk (T1cN1)
Patients with locally advanced inflammatory breast cancer
Patient has HER2-positive breast cancer as 3+ by IHC or in-situ hybridization (ISH) amplified BC patients
ER+ or ER-
Agree to informed consent and willing and able to comply with the protocol
Available pre-chemotherapy and surgery tissue (except pCR)
For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drugs. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year. Barrier methods must always be supplemented with the use of a spermicide.
Patient has adequate bone marrow and organ function
LVEF ≥55% at baseline
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeon-hee Park, MD,PhD | Contact | 2-3410-3459 | 82 | yeonh.park@samsung.com |
| hyunjung shin, CRC | Contact | 2-3410-6763 | 82 | hjds.shin@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35797012 | Derived | Ahn HK, Sim SH, Suh KJ, Kim MH, Jeong JH, Kim JY, Lee DW, Ahn JH, Chae H, Lee KH, Kim JH, Lee KS, Sohn JH, Choi YL, Im SA, Jung KH, Park YH. Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Sep 1;8(9):1271-1277. doi: 10.1001/jamaoncol.2022.2310. |
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(A, Neoadjuvant setting): TAHP (Docetaxel, Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 6 cycles q3weeks, intravenous(IV) administration
(B, Adjuvant setting) : patients with pCR: AHP(Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 11-12 cycles q3weeks
patients with non-pCR: Doxorubicin plus cyclophosphamide: D1 X 4cycles q3weeks followed by AHP (Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 11-12 cycles q3weeks
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| TAHP plus AC and AHP | Drug | (A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
(B, Adjuvant setting) : patients with non-pCR
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