Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

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 is a randomized, open-label phase 3 trial enrolling women with HER2-positive breast cancer that is stage II–III. Participants are assigned to either a two-phase neoadjuvant regimen (Pyrotinib with Trastuzumab and Docetaxel for two cycles, then Pertuzumab with Trastuzumab and Docetaxel for two cycles) or four cycles of Pertuzumab, Trastuzumab, and Docetaxel. The study also explores ctDNA clearance and MRI responses as exploratory endpoints. Multicenter participation is planned with the goal of comparing pathologic response and outcomes between the regimens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent.
2. Age: Female patients aged 18-70 years.
3. Breast cancer meeting the following criteria:

   1. Histologically confirmed invasive breast cancer, with primary tumor diameter ≥ 2.0 cm, Stage II-III as assessed by local standard methods.
   2. HER2-positive breast cancer, defined as Immunohistochemistry (IHC) score 3+ or In Situ Hybridization (ISH) showing HER2 gene amplification.
4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
5. All required baseline laboratory tests and imaging studies completed before randomization.
6. Adequate organ function
7. For non-menopausal (amenorrhea \< 12 months) or non-surgically sterile female patients (without ovaries and/or uterus): Agreement to abstain or use reliable and effective contraception during treatment and for at least 6 months after the last dose of study treatment.
8. Investigator judgment that the patient can comply with the study protocol.

Exclusion Criteria:

1. Bilateral breast cancer or metastatic (Stage IV) breast cancer.
2. Significant cardiac disease:

   1. History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the past 6 months.
   2. New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) or history of NYHA Class III or IV CHF.
   3. High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block.
   4. Angina requiring anti-anginal medication.
   5. Clinically significant valvular heart disease.
   6. ECG evidence of transmural myocardial infarction.
3. Other malignancies within the past 5 years, except cured carcinoma in situ of the cervix or non-melanoma skin cancer.
4. Severe systemic infection or patients with other serious diseases.
5. Major non-breast surgery within 4 weeks of randomization, or patients who have not fully recovered from such surgery.
6. Known history of Human Immunodeficiency Virus (HIV) infection.
7. Active hepatitis B or hepatitis C virus infection.
8. Known allergy or intolerance to the study drugs or their excipients.
9. Prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason.
10. Currently enrolled in or previously participated in a study of an investigational drug and received investigational treatment or used an investigational device within 4 weeks before the first dose of study treatment (12 months for investigational drugs/devices with anti-cancer or anti-proliferative properties).
11. Vaccination with a live vaccine within 30 days before the first dose of the investigational drug.
12. Psychiatric illness or substance abuse history that could affect compliance with trial requirements.
13. Pregnancy or breastfeeding, or female patients of childbearing potential who refuse to take appropriate contraceptive measures during the trial.
14. Patients judged by the investigator to be unsuitable for participation in this study.

Where it's running

• Ruijin Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Haoyu Wang
• Email: meredithwhy@163.com
• Phone: 86-021-64370045-602219

Similar studies

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

• Pre-surgery trastuzumab deruxtecan (SHR-A1811) plus pertuzumab for HER2-positive breast cancer

  This trial tests giving trastuzumab deruxtecan (SHR-A1811) with pertuzumab before surgery to see if it helps women with stage II–III HER2-positive breast cancer achieve a complete response.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07393425

• Intensified HER2-targeted treatment for people with a suboptimal response to initial dual HER2 therapy and chemotherapy

  This trial will try stronger targeted drug combinations for people with HER2-positive early breast cancer who don't respond well to initial dual HER2-targeted therapy plus chemotherapy.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou · NCT07340398

• 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

• 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

• Combining Pyrotinib and ARX788 for treating HER2-positive breast cancer

  This study is testing a new combination of two drugs, pyrotinib and ARX788, to see if it can help women with stage II-III HER2-positive breast cancer who haven't responded well to other treatments.

  Recruiting Phase 2 Shengjing Hospital · Shenyang, Liaoning · NCT04983121

• 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

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.