Neoadjuvant treatment for ER+/HER2+ breast cancer using a combination of drugs

A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab，Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer

This study is testing a new combination of drugs to see if it helps women with early or locally advanced HER2-positive breast cancer shrink their tumors before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: immunotherapy, radiation, trastuzumab, pyrotinib
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT06000917 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a combination therapy involving pyrotinib, trastuzumab, albumin paclitaxel, and carboplatin for patients with early or locally advanced ER+/HER2+ breast cancer. It is a multicenter, single-arm, prospective study designed to assess how well this treatment works as a neoadjuvant therapy before surgery. The study aims to recruit female patients aged 18 to 75 who meet specific health criteria and have a confirmed diagnosis of HER2-positive breast cancer. Participants will undergo treatment and be monitored for outcomes related to tumor response and safety.

Who should consider this trial

Good fit: Ideal candidates are newly diagnosed female patients aged 18 to 75 with early or locally advanced HER2-positive breast cancer.

Not a fit: Patients with non-HER2-positive breast cancer or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with ER+/HER2+ breast cancer by enhancing tumor response prior to surgery.

How similar studies have performed: Other studies have shown promising results with similar combination therapies for HER2-positive breast cancer, indicating potential for success in this approach.

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.

Where this trial is running

Wuhan, Hubei and 1 other locations

• WuhanHU — Wuhan, Hubei, China (Recruiting)
• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yao Jing

Conditions Breast Cancer; Neoadjuvant