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RECRUITING
NCT05420467
PHASE4

A Study for the Adjuvant Treatment of Breast Cancer

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, 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.

Official title: A Prospective, Open-label, Non-inferiority Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Adjuvant Treatment of Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2413

Start Date

2022-07-10

Completion Date

2027-12-20

Last Updated

2022-07-01

Healthy Volunteers

No

Conditions

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

DRUG

Cyclophosphamide

600 mg/m2, d1, q3w × 6 cycles

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China