Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The objective response rate
研究概览
简要总结
This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.
详细描述
This is a parallel-group, open-label randomized controlled trial designed to investigate the effects of supplemental vitamin D (VD) on the outcomes and side effects of neoadjuvant therapy in patients with breast cancer. Both groups will receive standard neoadjuvant therapy on day 1 and for each subsequent cycle. Additionally, vitamin D2 will be randomly administered to both groups.Blood samples and imaging results will be collected and analyzed prior to the initiation of neoadjuvant therapy and after every two cycles. Key outcomes to be recorded include the pathological complete response rate (pCR), objective response rate (ORR), disease control rate (DCR), and grade III or higher adverse effects related to neoadjuvant therapy. The primary and secondary study findings, along with adverse events, will be thoroughly evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
- •Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
- •Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5.neoadjuvant chemotherapy or combined targeted therapy.
- •6.Life expectancy of at least 6 months. 7.No other uncontrolled benign diseases at the time of recruitment. 8.All patients must have complete clinical medical records. 9.Willingness to voluntarily sign an informed consent form.
排除标准
- •History of invasive breast cancer.
- •Prior systemic treatment for the treatment or prevention of breast cancer.
- •Known allergic reactions to vitamin D or calcium compounds.
- •Comorbidities that may affect vitamin D or calcium balance or bone health.
- •Vitamin D or calcium supplementation in the past 3 months.
- •Presence of other tumors.
- •Pregnant or lactating women.
- •Individuals who do not wish to participate in the study.
研究组 & 干预措施
Neoadjuvant therapy + vitamin D2
Before the start of treatment and every 3 weeks thereafter, participants will receive injections of vitamin D2 at a dosage of 10 mg until the completion of neoadjuvant therapy. They will undergo the standard neoadjuvant regimen, which includes the 10 mg injection of vitamin D2 per cycle during the therapy. The dosage of neoadjuvant drugs may be tailored based on the physician's clinical judgment.
干预措施: Neoadjuvant therapy + vitamin D2 (Drug)
Neoadjuvant therapy
Participants will receive the standard neoadjuvant regimen during each cycle of neoadjuvant therapy. The dosage of the neoadjuvant drugs may be tailored based on the physician's clinical judgment.
干预措施: Neoadjuvant therapy (Drug)
结局指标
主要结局
The objective response rate
时间窗: 4-6months
Difference in change in the objective response rate from first to last assessment between two arms
The pathological complete response rate
时间窗: 4-6months
Difference in change the pathological complete response rate from first to last assessment between two arms
次要结局
- The disease control rate(4-6months)
- Evaluation of side effects related to neoadjuvant therapy (CTCAE v5.0).(From the initiation of neoadjuvant therapy to 21 days after the last cycle of neoadjuvant therapy.)
- Pathological response assessment using the Miller & Payne scoring system in conjunction with residual disease in lymph nodes following neoadjuvant therapy.(4-6months)
研究者
Jiuda Zhao
Breast Disease Diagnosis and Treatment Center
Affiliated Hospital of Qinghai University