- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04858529
Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)
Neoadjuvant TCHP Versus THP in Patients With Human Epidermal Growth Factor Receptor 2-positive Breast Cancer (neoCARHP) : a Randomized, Open-label, Multicenter, Phase III Trial
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Kun Wang, Phd
- Phone Number: 13922118086
- Email: gzwangkun@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- Guangdong Provincial People's Hospital
-
Contact:
- Kun Wang, Phd
- Phone Number: 13922118086
- Email: gzwangkun@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: THP
|
investigator-selected taxane/trastuzumab/pertuzumab (THP)
|
Active Comparator: TCHP
|
investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pathological complete response(ypT0/is,ypN0, pCR)
Time Frame: 18 weeks
|
defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response during neoadjuvant therapy
Time Frame: 18 weeks
|
Clinical response during neoadjuvant therapy, according to RECIST v1.1.
|
18 weeks
|
The percentage of patients who underwent breast-conserving surgery
Time Frame: 18 weeks
|
18 weeks
|
|
Event-free survival (EFS)
Time Frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
|
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)
Time Frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
|
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
Time Frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
|
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.
Time Frame: 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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20201101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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