Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06642428

Rekrutiert

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

Interventionsstudie

Phase nicht angegeben

Qinghai University Affiliated Hospital

Sponsor: Jiuda Zhao

Zuletzt aktualisiert: 17. Januar 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere Medikamente

Erforderliche Mutationen

Keine

Studie gestartet

18. Oktober 2024

Zuletzt vom Sponsor aktualisiert

17. Januar 2025

Voraussichtlicher Abschluss

31. Januar 2026

Studienkontakt

Name:Jiuda Zhao

E-Mail:jiudazhao@126.com

Telefon:869716230893

Eignung

Einschlusskriterien

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.

Ausschlusskriterien

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.

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Design-Details

ZuteilungRandomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer140

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: 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.

Interventionen:

Neoadjuvant therapy + vitamin D2
Neoadjuvant therapy

Ergebnismessungen

Primäre Ergebnismessungen

The objective response rate4-6months

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

The pathological complete response rate4-6months

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

Sekundäre Ergebnismessungen

The disease control rate4-6months

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

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.

Side effects of neoadjuvant therapy will be assessed according to the CTCAE v5.0 criteria.

Pathological response assessment using the Miller & Payne scoring system in conjunction with residual disease in lymph nodes following neoadjuvant therapy.4-6months

The pathological response will be assessed using the Miller & Payne scoring system, considering residual disease in lymph nodes after neoadjuvant therapy.

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Studienzentren

Diese Studie hat 1 Studienzentrum

Qinghai University Affiliated Hospital

Xining, Qinghai, CN

Name:Jiuda Zhao, Dr

E-Mail:jiudazhao@126.com

Telefon:869716230893

Rekrutiert noch nicht

Xining, Qinghai, 810000 CN

Qinghai University Affiliated Hospital

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