Status:
UNKNOWN
Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Neoadjuvant Therapies for HER2+ Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
774 Patients enrolled
Trial Details
Trial ID
NCT04858529
Start Date
April 30 2021
End Date
April 30 2025
Last Update
November 7 2023
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080