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RECRUITING
NCT03730922
NA

Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

Sponsor: Danish Breast Cancer Cooperative Group

View on ClinicalTrials.gov

Summary

In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.

Official title: The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

590

Start Date

2020-01-01

Completion Date

2035-11

Last Updated

2025-02-06

Healthy Volunteers

No

Interventions

PROCEDURE

Delayed-immediate reconstruction

Skin sparing mastectomy and reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Final reconstruction with any reconstructive procedure 6-12 months after completion of chemotherapy and RT.

PROCEDURE

Delayed reconstruction

Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT

Locations (8)

Åbenrå Sygehus

Aabenraa, Denmark

Ålborg Universitetshospital

Aalborg, Denmark

Århus Universitets Hospital

Aarhus, Denmark

Gentofte Hospital/Herlev Hospital

Copenhagen, Denmark

Esbjerg Sygehus

Esbjerg, Denmark

Sjællands Universitetshospital

Roskilde, Denmark

Vejle Sygehus

Vejle, Denmark

Viborg Sygehus

Viborg, Denmark