Clinical trial NCT06000917: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Neoadjuvant
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: total Pathological Complete Response(tPCR)
timeFrame: 2 years
Secondary outcomes:
measure: breast Pathological Complete Response(bPCR)
timeFrame: 2 years
measure: overall response rate(ORR)
timeFrame: 2 years
measure: event-free survival(EFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: WuhanHU
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: