NCT01769625

Prostaglandin Inhibition to Prevent Breast Cancer

Completed Phase 1/Phase 2 Last updated 8 August 2017

What this trial tests

Phase 1/Phase 2 trial testing placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU in Biomarker Change Linked to Breast Cancer in 31 participants. Completed in 1 November 2016.

Timeline

1 January 2009

Primary endpoint
1 November 2016

1 November 2016

Quick facts

Lead sponsor	Hartford Hospital
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	31
Start date	1 January 2009
Primary completion	1 November 2016
Estimated completion	1 November 2016
Sites	1 location across United States

Drugs / interventions tested

• placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU — full drug profile →

Conditions studied

• Biomarker Change Linked to Breast Cancer — all drugs for Biomarker Change Linked to Breast Cancer →

Sponsor

Hartford Hospital

Who can join

18 and older, female only, with Biomarker Change Linked to Breast Cancer. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast
  Time frame: approximately 30 days
  This will be measured from both baseline and completion samples 1\. PG synthesis and metabolism, through the measurement of 15-PGDH, COX-2, and PGE2 in the breast Rationale: 1,25(OH)2D, the active form of vitamin D, has been shown in vitro to decrease PGE2 both by interfering with its production and by increasing its breakdown, leading to lower cell proliferation. Celecoxib potentiated the antip

Sponsor's own description

This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.

The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lipid metabolic reprogramming in cancer cells.
   Beloribi-Djefaflia S, Vasseur S, Guillaumond F. · · 2016 · cited 1007× · PMID 26807644 · DOI 10.1038/oncsis.2015.49
2. Celecoxib in breast cancer prevention and therapy.
   Li J, Hao Q, Cao W, Vadgama JV, et al · · 2018 · cited 52× · PMID 30464589 · DOI 10.2147/cmar.s178567
3. Antioxidants for the Treatment of Breast Cancer: Are We There Yet?
   Griñan-Lison C, Blaya-Cánovas JL, López-Tejada A, Ávalos-Moreno M, et al · · 2021 · cited 43× · PMID 33572626 · DOI 10.3390/antiox10020205
4. The Effects of Vitamin D on the Breast Cancer Tumor Microenvironment.
   Kanwal B, Shah SS, Shaheen F, Shiferaw MS, et al · · 2025 · PMID 41374952 · DOI 10.3390/cancers17233751