ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC
NCT ID: NCT04172259
Last Updated: 2023-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
156 participants
INTERVENTIONAL
2019-01-10
2026-09-30
Brief Summary
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We update protocol in Sep 2020, because Pertuzumab is approveled by Chinese goverment and coverd by national insurance, dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients.
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Detailed Description
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We update protocol in Sep 2020, because Pertuzumab is approveled by Chinese goverment and coverd by national insurance, dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients. So now we want to compare ACHP-THP regimen compared with the EC-THP regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ACHP-THP
Doxorubicin liposome（PLD）35 mg/m2 Cyclophosphamide（CTX）600 mg/m2 Trastuzumab：first cycle 8mg/kg，then 6mg/kg Pertuzumab：first cycle 840mg，then 420mg Docetaxel（DOC）75 mg/m2 every 3 weeks paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week
Doxorubicin liposome
PLD
Cyclophosphamide
CTX
Trastuzumab
H
Docetaxel
DOC
Pertuzumab
P
Paclitaxel-albumin
albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week
EC-THP
Epirubicin（EPI）90 mg/m2 Cyclophosphamide（CTX）600 mg/m2 Trastuzumab：first cycle 8mg/kg，then 6mg/kg Pertuzumab：first cycle 840mg，then 420mg Docetaxel（DOC）75 mg/m2 every 3 weeks paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week
Cyclophosphamide
CTX
Trastuzumab
H
Docetaxel
DOC
Epirubicin
EPI
Pertuzumab
P
Paclitaxel
paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week
Paclitaxel-albumin
albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week
Interventions
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Doxorubicin liposome
PLD
Cyclophosphamide
CTX
Trastuzumab
H
Docetaxel
DOC
Epirubicin
EPI
Pertuzumab
P
Paclitaxel
paclitaxel (PTX) 175 mg/m2 every 3 weeks or paclitaxel (PTX) 80 mg/m2 every week
Paclitaxel-albumin
albumin-bound paclitaxel 260 mg/m2 or albumin-bound paclitaxel 100 mg/m2 every week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2-positive breast cancer
* Histologically confirmed invasive breast carcinoma
* Clinical stage T2-4/N0-3/M0 or node positive at presentation (patients with T1 tumors will not be eligible)
* Known hormone-receptor status
* Non previous anti-breast cancer neoadjuvant chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematologic, renal and liver function
* Screening Left ventricular ejection fraction (LVEF) \>/= 50% on echocardiogram (ECHO)
* Adequate organ function
Exclusion Criteria
* History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ)
* History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
* Cardiopulmonary dysfunction as defined by protocol
* Current severe, uncontrolled systemic disease
* Pregnant or lactating women
* Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
* Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
* History of intolerance, including Grade 3 to 4 infusion reaction or
* hypersensitivity to trastuzumab or chemotherapy drugs
18 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Xia Wen
Clinical Professor
Principal Investigators
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Wen Xia, MD
Role: PRINCIPAL_INVESTIGATOR
SunYat-sen University Cancer Center
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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Other Identifiers
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SCBCG-023
Identifier Type: OTHER
Identifier Source: secondary_id
METIS
Identifier Type: -
Identifier Source: org_study_id
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