Comparing targeted therapies for HER2 positive early breast cancer after surgery

A Randomized, Open-label, Multicenter Study Comparing Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer

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.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Drugs / interventions: trastuzumab, chemotherapy, immunotherapy, Pyrotinib
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05292742 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of continuing original targeted therapy versus a combination of trastuzumab, pyrotinib, and capecitabine as postoperative adjuvant therapy for patients with HER2 positive early breast cancer who did not achieve a pathological complete response (pCR) after neoadjuvant treatment. The study focuses on female patients aged 18 to 75 with confirmed invasive breast cancer and residual tumors following neoadjuvant therapy. Participants will receive either the combination therapy or continuation of trastuzumab with pertuzumab. The goal is to determine which approach offers better outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 75 with HER2 positive early breast cancer who have residual tumors after neoadjuvant therapy.

Not a fit: Patients who have not undergone neoadjuvant therapy or those with non-HER2 positive breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective postoperative treatment option for patients with HER2 positive early breast cancer.

How similar studies have performed: Other studies have shown promising results with targeted therapies in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Female patients aged ≥ 18 years and ≤ 75 years old with primary breast cancer
* ECOG score 0 \~ 1
* Breast cancer meets the following criteria: 1）Histologically or pathologically confirmed invasive breast cancer, primary tumor stage determined by standard evaluation methods：cT1-4/N0-3/M0. 2）Pathologically confirmed HER2-expressing positive breast cancer, defined as \> 10% immunoreactive cells with immunohistochemical (IHC) score of 3 + or in situ hybridization (ISH) results of HER2 gene amplification. 3)Known hormone receptor status (ER and PgR). 4)Neoadjuvant therapy (including: at least 9 weeks of trastuzumab treatment and at least 9 weeks of taxane chemotherapy)
* Primary breast cancer lesion or lymph node invasive cancer confirmed by pathology after neoadjuvant therapy (residual invasive breast cancer lesion \> 2 cm or axillary lymph node positive with macrometastasis assessed by central laboratory)
* No more than 12 weeks between end of surgery (without post-operative radiotherapy) and randomisation or 6 weeks between end of post-operative radiotherapy and randomisation
* Required laboratory values including following parameters:

ANC: ≥ 1.5 x 109/L Platelet count: ≥ 90 x 109/L Hemoglobin: ≥ 9.0 g/dL Total bilirubin: ≤ 1.5 x upper limit of normal, ULN ALT and AST: ≤ 1.5 x ULN BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 55% QTcF: \< 470 ms

Exclusion Criteria:

* 1\) Stage IV (metastatic) breast cancer;
* 2\) inflammatory breast cancer;
* 3\) Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma;
* 4\) Receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment);
* 5\) Receiving any anti-tumor therapy within 28 days before enrollment;
* 6\) Peripheral neuropathy ≥ Grade 2 as specified by NCI CTCAE;
* 7\) Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors;
* 8\) Receiving anthracycline therapy with cumulative doses as follows: adriamycin \> 240 mg/m2, epirubicin \> 480 mg/m2;
* 9\) Receiving major surgery unrelated to breast cancer before randomization, or the patient has not fully recovered from surgery

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Chuan Wang

Conditions Breast Cancer; Adjuvant Therapy