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A Study of Neoadjuvant TCHpy(Pyrotinib ,Trastuzumab,Carboplatin and Paclitaxel)for ER+/HER2+ Breast Cancer

Primary Purpose

Breast Cancer, Neoadjuvant

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pyrotinib,Trastuzumab,carboplatin,Albumin paclitaxel
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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: The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT≥90×109/L; Hb ≥90g/L 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); Cardiac color ultrasound and echocardiography: left ventricular ejection fraction(LVEF≥55%) 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.

Sites / Locations

  • WuhanHURecruiting
  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pyrotinib,Trastuzumab,carboplatin,Albumin paclitaxel

Arm Description

Pyrotinib tablets: 320mg qd, 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

Outcomes

Primary Outcome Measures

total Pathological Complete Response(tPCR)

Secondary Outcome Measures

breast Pathological Complete Response(bPCR)
overall response rate(ORR)
event-free survival(EFS)

Full Information

First Posted
August 8, 2023
Last Updated
August 18, 2023
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT06000917
Brief Title
A Study of Neoadjuvant TCHpy(Pyrotinib ,Trastuzumab,Carboplatin and Paclitaxel)for ER+/HER2+ Breast Cancer
Official Title
A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab,Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
May 11, 2025 (Anticipated)
Study Completion Date
May 11, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neoadjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pyrotinib,Trastuzumab,carboplatin,Albumin paclitaxel
Arm Type
Experimental
Arm Description
Pyrotinib tablets: 320mg qd, 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
Intervention Type
Drug
Intervention Name(s)
pyrotinib,Trastuzumab,carboplatin,Albumin paclitaxel
Intervention 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
Primary Outcome Measure Information:
Title
total Pathological Complete Response(tPCR)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
breast Pathological Complete Response(bPCR)
Time Frame
2 years
Title
overall response rate(ORR)
Time Frame
2 years
Title
event-free survival(EFS)
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT≥90×109/L; Hb ≥90g/L 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); Cardiac color ultrasound and echocardiography: left ventricular ejection fraction(LVEF≥55%) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Jing
Phone
13971139665
Email
jeaneyph@163.com
Facility Information:
Facility Name
WuhanHU
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Yao
Phone
02785726375
Email
jeaneyph@163.com
Facility Name
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Jing
Phone
13971139665
Email
jeaneyph@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Neoadjuvant TCHpy(Pyrotinib ,Trastuzumab,Carboplatin and Paclitaxel)for ER+/HER2+ Breast Cancer

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