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Trial Title:
A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER2+ Breast Cancer
NCT ID:
NCT06000917
Condition:
Breast Cancer
Neoadjuvant
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Carboplatin
Trastuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel
Description:
Pyrotinib tablets: 320mg qd, oral administration after breakfast, 21 days for 1 cycle,
continuous administration of 6 cycles.
Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days
was 1 cycle, continuous administration of 6 cycles.
Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days
for 1 cycle, and 6 consecutive cycles were given.
Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula,
with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles
of administration
Arm group label:
pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel
Summary:
This study is a multicenter, single-arm, prospective, open clinical study to evaluate the
efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and
carboplatin in neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Newly treated female patients aged ≥18 years and ≤75 years;
- ECOG score 0~1;
- Pathologically diagnosed as HER2-positive breast cancer patients with early or
locally advanced tumor stage, primary tumor diameter T≥2cm or lymph node positive;
- Hormone receptor status (ER and PgR) is known, where ER≥10%
- Normal function of major organs:
1. The standard of blood routine examination should meet: ANC ≥1.5×109/L;
PLT≥90×109/L; Hb ≥90g/L
2. Biochemical examination should meet the following standards: TBIL≤ the upper
limit of normal value(ULN); ALT and AST≤1.5 times the upper limit of normal
(ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and
Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula);
3. Cardiac color ultrasound and echocardiography: left ventricular ejection
fraction(LVEF≥55%)
4. Fridericia calibrated QT interval (QTcF) for 18-lead ECG <470 ms;
- For female patients who are not menopausal or have not been surgically sterilized:
consent to abstinence or use of an effective contraceptive method during treatment
and for at least 7 months after the last dose in the study treatment;
- Volunteer to join the study and sign the informed consent.
Exclusion Criteria:
- Stage IV (metastatic) breast cancer;
- Inflammatory breast cancer;
- Previous antitumor therapy or radiation therapy for any malignancies, excluding
cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma;
- Also receiving antitumor therapy in other clinical trials, including endocrine
therapy, bisphosphonate therapy, or immunotherapy;
- Had a major surgery not related to breast cancer in the 4 weeks prior to enrollment,
or had not fully recovered from such surgery;
- Serious heart disease or discomfort, including but not limited to the following:
- History of heart failure or systolic dysfunction (LVEF < 50%)
- High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart
rate >100 bpm, significant ventricular arrhythmias (such as ventricular
tachycardia), or higher-grade atrioventricular block (i.e. Mobitz II second-
degree atrioventricular block or third-degree atrioventricular block
- Inability to swallow, intestinal obstruction, or other factors affecting the use and
absorption of the drug;
- Known allergic history of the drug components of this protocol; A history of
immunodeficiency, including HIV testing positive, or other acquired, congenital
immunodeficiency diseases, or a history of organ transplantation;
- Women who are pregnant or nursing, women who are fertile and have a positive
baseline pregnancy test, or women of childbearing age who are unwilling to use
effective contraception throughout the trial period and within 7 months after the
last study medication;
- Have a serious concomitant condition or other comorbid condition that interferes
with planned treatment, or any other condition in which the investigator deems the
patient unsuitable for participation in the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
WuhanHU
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Yao
Phone:
02785726375
Email:
jeaneyph@163.com
Facility:
Name:
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Jing
Phone:
13971139665
Email:
jeaneyph@163.com
Start date:
May 11, 2023
Completion date:
May 11, 2028
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06000917
