RecruitingPhase 3NCT05760612

Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab

A Randomized, Open-Label, Phase III Trial Comparing Adjuvant Trastuzumab Plus Neratinib Versus Trastuzumab Plus Pertuzumab in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer With Residual Cancer Burden 0/I After Neoadjuvant Trastuzumab Plus Pertuzumab

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

300 participants

Start Date

Mar 14, 2023

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer Early Stage Breast Cancer Adjuvant Treatment After Trastuzumab RCB Classification 1-2 Neratini

Summary

Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer following neoadjuvant therapy. Furthermore, there are no prospective randomized controlled trials comparing trastuzumab plus pertuzumab versus trastuzumab plus TKIs in HER2-positive breast cancer patients with residual cancer burden class (RCB) I or II after neoadjuvant trastuzumab and pertuzumab. Therefore, this study aimed to evaluate the efficacy and safety of adjuvant trastuzumab plus neratinib in patients with hormone receptor-positive/HER2-positive breast cancer and RCB 0/I following neoadjuvant trastuzumab and pertuzumab therapy.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding neratinib to trastuzumab (both HER2-targeted drugs) after surgery improves outcomes for women with hormone receptor-positive, HER2-positive breast cancer who did not achieve a complete response to their pre-surgery chemotherapy. Residual disease after pre-surgery chemo is a sign of higher relapse risk. **You may be eligible if...** - You are female, 18–70 years old - You have hormone receptor-positive, HER2-positive breast cancer - You received pre-surgery chemotherapy with trastuzumab and pertuzumab and had remaining cancer in your tissue at the time of surgery (did not achieve complete pathological response) - Your cancer was at stage cT1-4/N1-3/M0 at diagnosis **You may NOT be eligible if...** - You have already received neratinib or similar HER2-targeted drugs beyond trastuzumab and pertuzumab - You have cancer that has spread to distant organs - You have significant heart problems, especially reduced heart pumping function - 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

DRUGTrastuzumab and neratinib

Trastuzumab (8 mg/kg IV loading dose, followed by 6 mg/kg IV once every 3 weeks), and neratinib 240 mg orally once daily. The trastuzumab treatment will be continued for a total of 18 cycles, encompassing both the preoperative and adjuvant phases, while neratinib will be maintained throughout the adjuvant period.

DRUGTrastuzumab and Pertuzumab

Trastuzumab (8 mg/kg IV loading dose, followed by 6 mg/kg IV once every 3 weeks), and pertuzumab (840 mg IV loading dose, followed by 420 mg IV once every 3 weeks). This regimen will be repeated for a total of 18 cycles,encompassing both the preoperative and adjuvant phases.