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Delayed-Delayed Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT01256528
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is completed).

Condition or disease Intervention/treatment
Breast Cancer Procedure: Delayed Breast Reconstruction

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multidisciplinary Protocol for Planned Skin-Preserving Delayed Breast Reconstruction for Patients With Locally Advanced Breast Cancer Requiring Postmastectomy Radiation Therapy
Study Start Date : December 2010
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Delayed Breast Reconstruction
Approximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT).
Procedure: Delayed Breast Reconstruction
Approximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT).


Outcome Measures

Primary Outcome Measures :
  1. Overall Complication Rate [ Time Frame: 6 months ]
    Overall complication defined as any of the following complications post breast reconstruction surgery: seroma, hematoma, wound dehiscence, partial flap loss, total flap loss, infection, flap microvascular thrombosis (arterial or venous), venous congestion of flap, flap fat necrosis, mastectomy skin flap necrosis, exposure breast implant, capsular contracture, and delayed wound healing.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with invasive breast carcinoma that are scheduled for a mastectomy with planned postmastectomy XRT. This includes, but is not limited to, clinical stage II, III, and IV.
  2. Patient must desire breast reconstruction.
  3. Patients must sign the informed consent form and must be deemed by operative surgeon not to have medical contraindications for delayed-delayed approach.
  4. Patients must be 18 years of age or older.

Exclusion Criteria:

  1. Patients in whom it is not known preoperatively to need postmastectomy radiation therapy.
  2. Patients with inflammatory breast cancer.
  3. Patients in whom the breast skin can not be spared because of involvement with breast cancer.
  4. Any patient deemed by the radiation oncologist during preoperative consultation to be an inappropriate patient for this protocol.
  5. Patients that can not commit to receiving postmastectomy radiation treatment in addition to breast reconstructive procedures at MD Anderson Cancer Center or satellite affiliates.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256528


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Steven J. Kronowitz, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01256528     History of Changes
Other Study ID Numbers: 2010-0053
NCI-2011-00270 ( Registry Identifier: NCI CTRP )
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016

Keywords provided by M.D. Anderson Cancer Center:
Invasive breast carcinoma
Breast reconstruction
Mastectomy
Breast cancer
Delayed-delayed breast reconstruction
Post-mastectomy radiation therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases