A Study for the Adjuvant Treatment of Breast Cancer

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.

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

DRUG

Cyclophosphamide

600 mg/m2, d1, q3w × 6 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

2027-07-10

Completion

2027-12-20

Countries

• China

Study Locations