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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jeaneyph@163.com
• Phone: 13971139665

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

  This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07615751

• Using blood ctDNA to compare two pre-surgery HER2-positive breast cancer regimens

  We will test whether two different pre-surgery drug combinations clear tumor DNA from the blood better in people with HER2-positive early breast cancer.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07335081

• Evaluating Pyrotinib for HER2-positive Advanced Breast Cancer

  This study is testing if a new drug called Pyrotinib, given with standard chemotherapy, can help people with advanced HER2-positive breast cancer feel better and improve their treatment outcomes.

  Recruiting Phase 1 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06770296

• Combination treatment for HR+/HER2+ breast cancer

  This study is testing a new combination treatment for patients with stage II-III HR+/HER2+ breast cancer to see if it works better than the standard treatment before surgery.

  Recruiting Phase 2 Shengjing Hospital · Shenyang, Liaoning · NCT05638594

• Comparing targeted therapies for HER2 positive early breast cancer after surgery

  This study is testing whether a new combination of treatments can help women with HER2 positive early breast cancer do better after surgery compared to sticking with their original therapy.

  Recruiting Phase 2 Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT05292742

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.