Clinical trial NCT06642428: Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
Official title: Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vitamin D
Neoadjuvant Therapy
Breast Cancer
Adverse Reaction
Efficacy
Chemotherapy
Keywords: Vitamin D
Breast Cancer
Adverse Reaction
Efficacy
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
2. Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
3. Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
4. 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.

Exclusion Criteria:

1. History of invasive breast cancer.
2. Prior systemic treatment for the treatment or prevention of breast cancer.
3. Known allergic reactions to vitamin D or calcium compounds.
4. Comorbidities that may affect vitamin D or calcium balance or bone health.
5. Vitamin D or calcium supplementation in the past 3 months.
6. Presence of other tumors.
7. Pregnant or lactating women.
8. Individuals who do not wish to participate in the study.

Primary outcomes:
measure: The objective response rate
timeFrame: 4-6months
measure: The pathological complete response rate
timeFrame: 4-6months
Secondary outcomes:
measure: The disease control rate
timeFrame: 4-6months
measure: Evaluation of side effects related to neoadjuvant therapy (CTCAE v5.0).
timeFrame: From the initiation of neoadjuvant therapy to 21 days after the last cycle of neoadjuvant therapy.
measure: Pathological response assessment using the Miller & Payne scoring system in conjunction with residual disease in lymph nodes following neoadjuvant therapy.
timeFrame: 4-6months
Other outcomes:
Locations:
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
Study officials:
References: