RecruitingPhase 4NCT05420467

A Study for the Adjuvant Treatment of Breast Cancer

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

2,413 participants

Start Date

Jul 10, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares different chemotherapy and targeted therapy regimens for women after breast cancer surgery, tailored to specific cancer subtypes. You may be eligible if... - You are a woman aged 18 or older - You have stage I to III breast cancer confirmed by biopsy or pathology, with no distant spread (M0) - You have had complete breast cancer surgery (R0 resection) with lymph node removal - You need adjuvant (post-surgery) chemotherapy as determined by your doctor - Your cancer type is triple-negative, luminal (hormone receptor-positive), or HER2-positive - You can start adjuvant therapy within 21 days of surgery - Your ECOG performance status is 0 or 1 with expected survival over 6 months You may NOT be eligible if... - You have distant metastases - Your cancer does not fall into the specified subtypes - You cannot start treatment within 21 days of surgery - Your overall health status does not meet eligibility standards 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

DRUGCyclophosphamide

600 mg/m2, d1, q3w × 6 cycles


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT05420467


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