Overview
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.
Eligibility
Inclusion Criteria:
- To take part in the trial, patients must be aged > 18 years old and supply a signed informed consent form.
Patients must also have breast cancer meeting the following criteria:
- Histologically confirmed invasive breast carcinoma
- Clinical stage II-IIIC at presentation. HER2-positive breast cancer scored as 3+ by immunohistochemistry (IHC) in > 10% of immunoreactive cells, or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals ≥2.0) by in situ hybridization (ISH).
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:
- Stage IV (metastatic) breast cancer Inflammatory breast cancer Previous anti-cancer
therapy or radiotherapy for any malignancy. A history of other malignancies, except
for carcinoma in situ of the cervix or squamous or basal cell carcinoma.
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.