RecruitingPhase 3NCT04547907

A Comparison of Nab-PHP and TCbHP Efficacy 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

688 participants

Start Date

Sep 18, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer,HER2-positive

Summary

The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two pre-surgery chemotherapy combinations in women with HER2-positive early-stage breast cancer: nab-paclitaxel plus pertuzumab, trastuzumab, and carboplatin (Nab-PHP) versus standard paclitaxel plus carboplatin, pertuzumab, and trastuzumab (TCbHP), to see which achieves better tumor shrinkage before surgery. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have confirmed HER2-positive invasive breast cancer (stage T2–T4d, or T1c with positive lymph nodes) - Your cancer has measurable disease on imaging - Your blood counts and organ function are adequate for chemotherapy **You may NOT be eligible if...** - Your cancer is HER2-negative - You have already started chemotherapy for this cancer - You have significant heart 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

DRUGNab-paclitaxel+ trastuzumab+ patuzumab

Nab-paclitaxel 125mg/m2 (days 1, 8, 15) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.

DRUGDocetaxel+ carboplatin+ trastuzumab + patuzumab

Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.

Locations(1)

Henan cancer hospital

Zhengzhou, Henan, China

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NCT04547907