NCT04854525 is a clinical trial of Pre reconstruction Radiotherapy in Mammaplasty, sponsored by Humanitas Clinical and Research Center.

Who is sponsoring NCT04854525?

NCT04854525 is sponsored by Humanitas Clinical and Research Center.

What drugs are being tested in NCT04854525?

Interventions in NCT04854525: Pre reconstruction Radiotherapy.

What condition does NCT04854525 study?

NCT04854525 studies Mammaplasty, Radiotherapy; Complications, Breast Implant; Complications, Transplant Failure.

Is NCT04854525 still recruiting?

NCT04854525 is currently completed. Last updated 22 April 2021.

Last reviewed 2021-04-22 · How we verify

NCT04854525

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Breast Reconstruction in Previously Irradiated Breast

Completed Last updated 22 April 2021

What this trial tests

trial testing Pre reconstruction Radiotherapy in Mammaplasty in 2,150 participants. Completed in 25 January 2021.

Timeline

6 June 2020

Primary endpoint
23 November 2020

25 January 2021

Quick facts

Lead sponsor	Humanitas Clinical and Research Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,150
Start date	6 June 2020
Primary completion	23 November 2020
Estimated completion	25 January 2021
Sites	1 location across Italy

Drugs / interventions tested

Pre reconstruction Radiotherapy

Conditions studied

Mammaplasty — all drugs for Mammaplasty →
Radiotherapy; Complications — all drugs for Radiotherapy; Complications →
Breast Implant; Complications — all drugs for Breast Implant; Complications →
Transplant Failure — all drugs for Transplant Failure →

Sponsor

Humanitas Clinical and Research Center

Who can join

Adults 18 to 80, female only, with Mammaplasty or Radiotherapy; Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life. There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction. Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes. As a consequence, plastic surgeons come into contact with more patients with a history of irradiation of their breasts than ever before. However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction. The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Mammaplasty

Currently open trials in the same condition.

NCT06725459 — NPWT Reduction Mammaplasty · NA · recruiting
NCT07008339 — Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection. · NA · recruiting
NCT06274736 — Safety and Performance of Motiva® Sizers · recruiting
NCT04715802 — Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel · active not recruiting

Other Humanitas Clinical and Research Center trials

Trials by the same sponsor.

NCT07161297 — Remimazolam for Colonoscopy in IBD Patients · Phase 4 · not yet recruiting
NCT04934943 — "Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools" · not yet recruiting
NCT06394947 — Fluid Challenge in Intensive Care The FENICE II Study · completed
NCT06627907 — Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room. · not yet recruiting
NCT06099171 — Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck Pain · Phase 3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04854525 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Humanitas Clinical and Research Center
Last refreshed: 22 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04854525.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing