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RecruitingPhase 4NCT05420454

A Study for the Neoadjuvant Treatment of Breast Cancer

A Prospective, Open-label Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

1,576 participants

Start Date

Jul 10, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

Due to the unique advantages of albumin-bound paclitaxel, several studies in China and abroad have tried to use albumin-bound paclitaxel for neoadjuvant treatment of breast cancer up to now. However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying different neoadjuvant (pre-surgery) chemotherapy regimens based on breast cancer subtype to see which works best at shrinking tumors before surgery. **You may be eligible if...** - You are a woman, 18 or older, with a confirmed invasive breast cancer larger than 2 cm or with lymph node involvement - Your hormone receptor (ER/PR), HER2, and Ki67 status has been confirmed - You have triple-negative, HER2-positive, or luminal (hormone receptor-positive) breast cancer with qualifying features - You have not received any prior breast cancer treatment - Your heart function and overall health are within normal limits **You may NOT be eligible if...** - You have already received treatment for breast cancer - Your cancer has spread to distant organs - Your heart function is abnormal - Your overall health score is 2 or higher (moderate or poor daily functioning) 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

DRUGDocetaxel

75 mg/m2, d1, q3w,6 cycles

DRUGCarboplatin

AUC 6, d1, q3w ,6 cycles

DRUGTrastuzumab

starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w ,6 cycles

DRUGPertuzumab

starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w,6 cycles

DRUGNab paclitaxel

220 mg/m2, d1, q3w,6 cycles

DRUGEpirubicin

90 mg/m2,d1, q3w × 4 cycles,followed by docetaxel

DRUGCyclophosphamide

600 mg/m2, d1, q3w ,4 cycles,followed by docetaxel

DRUGDocetaxel

100 mg/m2, d1, q3w × 4 cycles

DRUGEpirubicin

90 mg/m2,d1, q2w × 4 cycles,followed by nab-paclitaxel

DRUGCyclophosphamide

600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel

DRUGNab paclitaxel

125 mg/m2, d1,8,15, q3w× 4 cycles

Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT05420454

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