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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Chemotherapy; Efficacy; Neoadjuvant Therapy; Vitamin D; Adverse Reaction
• Intervention / Treatment: Drug: Neoadjuvant therapy + vitamin D2; Drug: Neoadjuvant therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiuda Zhao; Phone Number: 869716230893; Email: jiudazhao@126.com

Study Locations

• China
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Recruiting
      • Qinghai University Affiliated Hospital
    • Xining, Qinghai, China, 810000
      • Not yet recruiting
      • Qinghai University Affiliated Hospital
      • Contact: Jiuda Zhao, Dr; Phone Number: 869716230893; Email: jiudazhao@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 + 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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The objective response rate	Difference in change in the objective response rate from first to last assessment between two arms	4-6months
The pathological complete response rate	Difference in change the pathological complete response rate from first to last assessment between two arms	4-6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The disease control rate	Difference in change the disease control rate rate from first to last assessment between two arms	4-6months
Evaluation of side effects related to neoadjuvant therapy (CTCAE v5.0).	Side effects of neoadjuvant therapy will be assessed according to the CTCAE v5.0 criteria.	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.	The pathological response will be assessed using the Miller & Payne scoring system, considering residual disease in lymph nodes after neoadjuvant therapy.	4-6months

Collaborators and Investigators

• Sponsor: Jiuda Zhao

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 13, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Vitamin D; Efficacy; Adverse Reaction
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D; Ergocalciferols
• Other Study ID Numbers: AHQU-2024003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No