Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC

NCT07797218 | Recruiting Phase 3

• 1 other identifier: RJBC2602
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

breast cancer; HER2-positive; Neoadjuvant; Pyrotinib; ctDNA

Outcome Measures

Primary Outcomes (1)

• tpCR

  After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained of breast and lymph node samples

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (7)

• bpCR

  From enrollment to the end of treatment at 24 weeks

• EFS

  through study completion, an average of 2 year

• OS

  through study completion, an average of 5 year

• Early ctDNA clearance

  From enrollment to the end of treatment at 24 weeks

• Late ctDNA clearance

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

TPyP

EXPERIMENTAL

2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel

Drug: Docetaxel; Drug: Pyrotinib; Drug: Trastuzumab (Herceptin); Drug: Pertuzumab

TP

ACTIVE COMPARATOR

4 cycles of Pertuzumab + Trastuzumab + Docetaxel

Drug: Docetaxel; Drug: Trastuzumab (Herceptin); Drug: Pertuzumab

Interventions

Docetaxel DRUG

docetaxel ivgtt q3w, 80-100mg/m2

TP; TPyP

Pyrotinib DRUG

pyrotinib 320mg p.o. qd

TPyP

Trastuzumab (Herceptin) DRUG

trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance, or 600mg sc q3w

TP; TPyP

Pertuzumab DRUG

pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance

TP; TPyP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Age: Female patients aged 18-70 years.
• Breast cancer meeting the following criteria:
• Histologically confirmed invasive breast cancer, with primary tumor diameter ≥ 2.0 cm, Stage II-III as assessed by local standard methods.
• HER2-positive breast cancer, defined as Immunohistochemistry (IHC) score 3+ or In Situ Hybridization (ISH) showing HER2 gene amplification.
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
• All required baseline laboratory tests and imaging studies completed before randomization.
• Adequate organ function
• 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.
• Investigator judgment that the patient can comply with the study protocol.

You may not qualify if:

• Bilateral breast cancer or metastatic (Stage IV) breast cancer.
• Significant cardiac disease:
• History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the past 6 months.
• New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) or history of NYHA Class III or IV CHF.
• 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.
• Angina requiring anti-anginal medication.
• Clinically significant valvular heart disease.
• ECG evidence of transmural myocardial infarction.
• Other malignancies within the past 5 years, except cured carcinoma in situ of the cervix or non-melanoma skin cancer.
• Severe systemic infection or patients with other serious diseases.
• Major non-breast surgery within 4 weeks of randomization, or patients who have not fully recovered from such surgery.
• Known history of Human Immunodeficiency Virus (HIV) infection.
• Active hepatitis B or hepatitis C virus infection.
• Known allergy or intolerance to the study drugs or their excipients.
• Prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; pyrotinib; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Haoyu Wang

CONTACT

86-021-64370045-602219; meredithwhy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: September 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

CN (1)