RecruitingPhase 3NCT05159193

Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

A Multicentre, Open-label, Randomised Trial of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer

Sponsor

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

Enrollment

372 participants

Start Date

Dec 20, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This is a multicenter, open label, non-inferiority, randomized controlled clinical study. The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoadjuvant treatment of HER-2-positive breast cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different chemotherapy combinations given before surgery (neoadjuvant treatment) in women with HER2-positive breast cancer. Researchers want to find out which combination shrinks tumors more effectively before surgery. **You may be eligible if...** - You are a woman aged 18–70 years - You have HER2-positive invasive breast cancer confirmed by biopsy, with no prior treatment - Your tumor is larger than 2 cm and has spread to nearby lymph nodes - Your cancer is operable and classified as stage cT2–cT4 / cN1–cN3 / cM0 - Your heart function and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have already received cancer treatment - You have serious heart disease or uncontrolled high blood pressure - You have poor liver, kidney, or bone marrow 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

DRUGpegylated liposomal doxorubicin (PLD)

pegylated liposomal doxorubicin (PLD) 30 mg/m\^2, i.v., d1, q3w

DRUGcyclophosphamide (C)

cyclophosphamide (C) 600 mg/m\^2, i.v., d1, q3w

DRUGtrastuzumab (H)

trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w

DRUGpertuzumab (P)

pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w

DRUGdocetaxel (T)

docetaxel (T) 90\~100 mg/m\^2, i.v., d1, q3w

DRUGdocetaxel (T)

docetaxel (T) 75 mg/m\^2, i.v., d1, q3w

DRUGcarboplatin (Cb)

carboplatin (Cb) AUC 6, i.v., d1, q3w

DRUGtrastuzumab (H)

trastuzumab (H) 8 mg/kg loading dose, 6 mg/kg maintenance doses, i.v., d1, q3w

DRUGpertuzumab (P)

pertuzumab (P) 840 mg loading dose, 420 mg maintenance doses, i.v., d1, q3w

Locations(1)

Sunyat-sen Memorial Hospital

Guandong, Guangdong, China

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NCT05159193

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