Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant therapy + vitamin D2, Neoadjuvant therapy.
- Who it may be relevant to
- Registry conditions: Vitamin D, Neoadjuvant Therapy, Breast Cancer, Adverse Reaction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 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. - 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.
Primary outcome measures
- The objective response rate [Time frame: 4-6months]
- The pathological complete response rate [Time frame: 4-6months]
Secondary outcome measures (3)
- The disease control rate [Time frame: 4-6months]
- Evaluation of side effects related to neoadjuvant therapy (CTCAE v5.0). [Time frame: 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. [Time frame: 4-6months]
Eligibility criteria
Inclusion criteria
- Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Qinghai University Affiliated Hospital — Xining
- Qinghai University Affiliated Hospital — Xining
Identifiers
NCT: NCT06642428 · AHQU-2024003