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

NCT06642428 | Recruiting DMC

• 1 other identifier: AHQU-2024003
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Vitamin D; Breast Cancer; Adverse Reaction; Efficacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Neoadjuvant therapy + vitamin D2

EXPERIMENTAL

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

Neoadjuvant therapy

OTHER

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

Interventions

Neoadjuvant therapy + vitamin D2 DRUG

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.

Neoadjuvant therapy + vitamin D2

Neoadjuvant therapy DRUG

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.

Neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiuda Zhao: lead

Study Sites (2)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

NOT YET RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy; Ergocalciferols

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Jiuda Zhao

CONTACT

869716230893; jiudazhao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Breast Disease Diagnosis and Treatment Center

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: October 18, 2024
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: January 17, 2025

Record last verified: 2024-10

Locations

CN (2)