Comparing targeted therapies for HER2 positive early breast cancer after surgery

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Chuan Wang
• Email: chuanwang68@qq.com
• Phone: 13515020716

Similar studies

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

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

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

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• Evaluating Pyrotinib for HER2-positive Advanced Breast Cancer

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

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  Recruiting at 2 sites Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei and 1 other locations · NCT06000917

• Combination treatment for HR+/HER2+ breast cancer

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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.