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The neoCARHP study was a randomized, open-label, multicenter, phase III, neoadjuvant trial. This study aimed to compare the efficacy and safety of TCHP with THP neoadjuvant setting for HER2-positive breast cancer. Patients will be randomized at a 1:1 ratio into TCHP or THP, respectively, and will be treated every 3 weeks before surgery.The primary endpoint was the percentage of pCR (ypT0/is, ypN0), which was defined as the absence of any residual invasive cancer in both the breast and axillary lymph nodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THP | Experimental |
| |
| TCHP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) | Drug | investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response(ypT0/is,ypN0, pCR) | defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0 | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response during neoadjuvant therapy | Clinical response during neoadjuvant therapy, according to RECIST v1.1. | 18 weeks |
| The percentage of patients who underwent breast-conserving surgery |
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Inclusion Criteria:
Patients must also have breast cancer meeting the following criteria:
Known hormone receptor status (ER and PR). Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. Completed all necessary baseline laboratory and radiologic examinations prior to randomization.
Baseline left ventricular ejection fraction (LVEF)≥55% measured by echocardiography (ECHO).
Women who are not postmenopausal (≥12 months of amenorrhea) or surgically sterile (absence of ovaries and/or the uterus) must agree to remain abstinent or to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception during the treatment period and for at least 6 months after the last dose of study treatment.
Clinical diagnosis of Alzheimer's Disease. Must be able to swallow tablets. All patients must be able to comply with the study protocol, according to the investigator's judgment.
Exclusion Criteria:
Concurrent anti-cancer treatment in another clinical trial, including hormone therapy, bisphosphonate therapy, or immunotherapy.
Received a major non-breast cancer-related surgical procedure within the 4 weeks before randomization or from which the patient has not fully recovered.
A serious cardiac illness or medical condition, including but not limited to the following:
Documented history heart failure or systolic dysfunction (LVEF < 50%). High-risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate >100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block).
Angina pectoris requiring anti-angina medication. Clinically significant valvular heart disease. Evidence of transmural infarction on ECG Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness.
Any of the following abnormal laboratory tests immediately prior to randomization:
Total bilirubin > 1.5 × upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin > 2 × ULN Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.25 × ULN Alkaline phosphatase > 2.5 × ULN Serum creatinine > 1.5 × ULN Total white blood cell (WBC) count < 2500 cells/uL Absolute neutrophil count <1500 cells/uL Platelet count <100,000 cells/uL Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol Pregnant or lactating: a negative serum pregnancy test is required for all women who are not postmenopausal (≥ 12 months of amenorrhea).
Insulin dependent diabetes. Thyroid disease.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun Wang, Phd | Contact | 13922118086 | gzwangkun@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41576297 | Derived | Gao HF, Ye GL, Lin Y, Huang Q, Dong J, Cao Y, Zhao YX, Chen QJ, Ma SH, Ouyang J, Ye JH, Yang HW, Zhang YQ, Zhang YC, Zhang GL, Li W, Zhang Y, Wu ZY, Lin YY, Zhu T, Zhang LL, Yang CQ, Yang M, Peng H, Chen B, Chen YT, Ji F, Cheng MY, Li JQ, Jiang Z, Wang K. Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP Trial. J Clin Oncol. 2026 Jun 10;44(17):1587-1596. doi: 10.1200/JCO-25-02176. Epub 2026 Jan 23. | |
| 38918556 |
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| investigator-selected taxane/trastuzumab/pertuzumab (THP) | Drug | investigator-selected taxane/trastuzumab/pertuzumab (THP) |
|
| 18 weeks |
| Event-free survival (EFS) | Event-free survival (EFS), defined as the time from randomization to the first report of one of the following events:
| until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first. |
| Disease-free survival (DFS) | Disease-free survival (DFS), defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of one of the following events:
| until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first. |
| Safety Outcome Measures | The safety outcome measures for this study are the incidence, type, and severity of adverse events and serious adverse events. | until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first. |
| Overall survival, defined as the time from randomization to death from any cause. | Overall survival, defined as the time from randomization to death from any cause. | from randomization to death from any cause. |
| Derived |
| Zhu T, Huang YH, Li W, Wu CG, Zhang YM, Zheng XX, Zhang TF, Lin YY, Liu ZY, Ye GL, Lin Y, Wu ZY, Wang K. A non-invasive artificial intelligence model for identifying axillary pathological complete response to neoadjuvant chemotherapy in breast cancer: a secondary analysis to multicenter clinical trial. Br J Cancer. 2024 Sep;131(4):692-701. doi: 10.1038/s41416-024-02726-3. Epub 2024 Jun 25. |