RecruitingPhase 2NCT05292742

Compare 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

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


Sponsor

Fujian Medical University Union Hospital

Enrollment

206 participants

Start Date

Jul 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment approaches in women with HER2-positive early breast cancer who received chemotherapy before surgery but still had cancer remaining after surgery. It compares continuing the original targeted therapy versus switching to a combination of trastuzumab, pyrotinib, and capecitabine. **You may be eligible if...** - You are a woman aged 18–75 with early-stage breast cancer - Your cancer is HER2-positive (confirmed by biopsy) - You received at least 9 weeks of trastuzumab and taxane chemotherapy before surgery - You still had invasive cancer in your breast or lymph nodes after surgery - You are in good general health (ECOG 0–1) - Your hormone receptor status (ER and PR) is known **You may NOT be eligible if...** - You had a complete cancer response to pre-surgery chemotherapy (no cancer remaining) - You have metastatic (stage IV) breast cancer - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPyrotinib+Trastuzumab+Capecitabine

Patients in the experimental arm will receive trastuzumab + pyrotinib + capecitabine

DRUGTrastuzumab+Pertuzumab/Trastuzumab

Trastuzumab: Initial loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks. One year of trastuzumab treatment (including: neoadjuvant phase and adjuvant phase) Pertuzumab: 840 mg loading dose followed by 420 mg fixed dose


Locations(1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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NCT05292742


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