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

ConditionsVitamin DNeoadjuvant TherapyBreast CancerAdverse ReactionEfficacyChemotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiuda Zhao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant therapy + vitamin D2Experimental treatment 1 intervention
Group B: Neoadjuvant therapyOther 1 intervention

Trial outcomes

Primary outcomes

1

The objective response rate

Difference in change in the objective response rate from first to last assessment between two arms

Time frame
4-6months
2

The pathological complete response rate

Difference in change the pathological complete response rate from first to last assessment between two arms

Time frame
4-6months

Secondary outcomes

1

The disease control rate

Difference in change the disease control rate rate from first to last assessment between two arms

Time frame
4-6months
2

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.

Time frame
From the initiation of neoadjuvant therapy to 21 days after the last cycle of neoadjuvant therapy.
3

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.

Time frame
4-6months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiuda Zhao

Lead sponsor

Affiliated Hospital of Qinghai University

Sponsor institution

Source ClinicalTrials.gov
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