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

NCT ID: NCT06000917

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-11
• Study Completion Date: 2028-05-11

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.

Conditions

Breast Cancer; Neoadjuvant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel

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

Group Type: EXPERIMENTAL

pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel

Intervention Type: DRUG

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

Interventions

pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

WuhanHU

Wuhan, Hubei, China

Site Status: RECRUITING

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yao Jing

Role: CONTACT

jeaneyph@163.com

13971139665

Facility Contacts

Jing Yao

Role: primary

jeaneyph@163.com

02785726375

Yao Jing

Role: primary

jeaneyph@163.com

13971139665

Other Identifiers

UHCT22745

Identifier Type: -

Identifier Source: org_study_id