Effect of methylcobalamin on capecitabine-induced hand-foot syndrome in patients with HER2-negative early breast cancer: A multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

Our objective was to evaluate whether methylcobalamin could effectively and safely prevent hand-foot syndrome (HFS) in human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) patients receiving adjuvant capecitabine treatment. We conducted a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. The trials were conducted across seven hospitals in China between January 2022 and February 2024. Study participants were women aged 18 to 75 years with pathologically confirmed HER2-negative EBC who were scheduled to receive adjuvant capecitabine therapy. Eligible patients were randomly assigned in a 1:1 ratio to receive methylcobalamin at a dose of 0.5mg orally, three times daily, or a placebo for a maximum of 24 weeks. The primary endpoint was the incidence of grade ≥2 HFS at any time of the first occurrence during capecitabine treatment in the intention-to-treat analysis. 234 patients were randomly assigned to receive methylcobalamin (n=117) or p..., , # Data from: Effect of methylcobalamin on capecitabine-induced hand-foot syndrome in patients with HER2-negative early breast cancer: A multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

Dataset DOI: [10.5061/dryad.gmsbcc31k](10.5061/dryad.gmsbcc31k)

## Description of the data and file structure

This dataset is the raw data for the Glorious trial, which aimed to verify the efficacy and safety of methylcobalamin in preventing grade 2 or 3 HFS as compared with placebo among patients with HER2-negative EBC receiving adjuvant capecitabine treatment. Assessment through the phase 3, multicentre, placebo-controlled, double-blind, randomized design, and corresponds to the paper entitled \"Effect of methylcobalamin on capecitabine-induced hand-foot syndrome in patients with HER2-negative early breast cancer: a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial\".

### Files and variables

#### File: Anonymised_data.xlsx

**Description:** Raw data for ..., Ethics approval was obtained from the ethics committee of each hospital and all participants signed written informed consent. The study was conducted in accordance with the Declaration of Helsinki. All information that might disclose the identity of the subjects has been removed.

本研究旨在评估甲基钴胺素（methylcobalamin）能否安全有效地预防接受辅助卡培他滨治疗的人表皮生长因子受体2（HER2）阴性早期乳腺癌（EBC）患者的手足综合征（HFS）。本研究开展了一项多中心、双盲、随机、安慰剂对照的Ⅲ期临床试验。该试验于2022年1月至2024年2月期间在中国7家医院开展。

研究纳入的受试者为年龄18~75岁、经病理证实为HER2阴性早期乳腺癌且计划接受辅助卡培他滨治疗的女性患者。符合入组标准的患者按1:1比例随机分组，分别接受口服甲基钴胺素（0.5mg/次，每日3次）或安慰剂治疗，最长治疗周期为24周。

本研究的主要终点为意向治疗分析（intention-to-treat analysis）中，卡培他滨治疗期间首次出现≥2级手足综合征的发生率。共234例患者被随机分配至甲基钴胺素组（n=117）或安慰剂组（原文此处内容截断）……

本数据集源自研究论文《Effect of methylcobalamin on capecitabine-induced hand-foot syndrome in patients with HER2-negative early breast cancer: A multicentre, double-blind, randomised, placebo-controlled, phase 3 trial》，即《甲基钴胺素对HER2阴性早期乳腺癌患者卡培他滨诱导性手足综合征的影响：一项多中心、双盲、随机、安慰剂对照Ⅲ期临床试验》。

数据集DOI：10.5061/dryad.gmsbcc31k

## 数据与文件结构说明
本数据集为Glorious试验的原始数据，该试验旨在验证相较于安慰剂，甲基钴胺素在预防接受辅助卡培他滨治疗的HER2阴性早期乳腺癌患者发生2~3级手足综合征方面的有效性与安全性。本试验采用Ⅲ期、多中心、安慰剂对照、双盲、随机化研究设计，对应上述标题的研究论文。

### 文件与变量
#### 文件：Anonymised_data.xlsx
**文件说明：** 原始数据……本研究已获得各医院伦理委员会的伦理审查批准，所有受试者均签署了书面知情同意书。本研究严格遵循《赫尔辛基宣言》开展。所有可能泄露受试者身份的信息均已完成匿名化处理。