Delayed-Immediate Breast Reconstruction

NCT00473122 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-07-15

No results posted yet for this study

Summary

The goal of this clinical research study is to evaluate a new two-stage approach (delayed-immediate reconstruction) to breast reconstruction in women who may require post-mastectomy radiation therapy. Researchers will compare the cosmetic outcomes and any complications that occur in women who receive delayed-immediate reconstruction to those who receive the standard approaches (either immediate reconstruction or delayed breast reconstruction).

Conditions

Interventions

PROCEDURE

Delayed-Immediate Breast Reconstruction

Immediate reconstruction surgery if no XRT required; or reconstruction surgery delayed until XRT complete.

Sponsors & Collaborators

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Steven J. Kronowitz, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT00473122 on ClinicalTrials.gov