RecruitingPhase 3NCT07057427

Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer

Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial

Sponsor

Henan Cancer Hospital

Enrollment

812 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two chemotherapy combination regimens — nab-PHP (nab-paclitaxel + pertuzumab + trastuzumab) versus TCbHP (taxotere + carboplatin + pertuzumab + trastuzumab) — as pre-surgery (neoadjuvant) treatment for women with HER2-positive early breast cancer. Researchers want to find out which combination shrinks the tumor more effectively before surgery. **You may be eligible if...** - You are 18–70 years old with HER2-positive invasive breast cancer confirmed by biopsy - Your tumor is stage T2–T4d, or T1c with lymph node involvement - Your tumor is measurable by ultrasound or MRI - Your blood counts, heart function (ejection fraction ≥55%), liver, and kidney function meet requirements - You have not started any treatment yet for this cancer **You may NOT be eligible if...** - Your cancer is not HER2-positive - You have metastatic (stage IV) breast cancer - You have heart problems with ejection fraction below 55% - 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

DRUGNab paclitaxel

Nab-paclitaxel (on days 1 and 8 of a 21-day cycle)

DRUGDocetaxel and Carboplatin

Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1)

DRUGTrastuzumab + Pertuzumab

Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.

Locations(1)

Henan cancer hospital

Zhengzhou, Henan, China

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NCT07057427

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