A Study for the Neoadjuvant Treatment of 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.

Conditions

• Breast Cancer

Interventions

DRUG

Docetaxel

75 mg/m2, d1, q3w,6 cycles

DRUG

Carboplatin

AUC 6, d1, q3w ,6 cycles

DRUG

Trastuzumab

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

DRUG

Pertuzumab

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

DRUG

Nab paclitaxel

220 mg/m2, d1, q3w,6 cycles

DRUG

Epirubicin

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

DRUG

Cyclophosphamide

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

DRUG

Docetaxel

100 mg/m2, d1, q3w × 4 cycles

DRUG

Epirubicin

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

DRUG

Cyclophosphamide

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

DRUG

Nab paclitaxel

125 mg/m2, d1,8,15, q3w× 4 cycles

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-10

Primary Completion

2027-06-10

Completion

2027-12-20

Countries

• China

Study Locations