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

NCT03730922 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm Female
  • Complication of Radiation Therapy
  • Breast Implant; Complications

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

Sponsors & Collaborators

  • Danish Breast Cancer Cooperative Group

    lead OTHER

Principal Investigators

  • Birgitte V Offersen, Professor · DBCG

  • Tove F Tvedskov, DMSc · DBCG

  • Tine Damsgaard, Professor · DBCG

  • Peer Christiansen, Professor · DBCG

  • Majbrit Jensen, MSc · DBCG

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2025-11-30
Completion
2035-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03730922 on ClinicalTrials.gov