Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer

Jiuda Zhao

Status: Enrolling

Conditions: Breast Cancer; Chemotherapy; Adverse Reaction; Efficacy; Neoadjuvant Therapy; Vitamin D

Treatments: Drug: Neoadjuvant therapy + vitamin D2; Drug: Neoadjuvant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06642428

AHQU-2024003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Neoadjuvant therapy + vitamin D2

Experimental group

Description:

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.

Treatment:

Drug: Neoadjuvant therapy + vitamin D2

Neoadjuvant therapy

Other group

Description:

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.

Treatment:

Drug: Neoadjuvant therapy