Breast Cancer Clinical Trial

Comparing Two Different Surgical Techniques for Breast Reconstruction

Summary

The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle.

The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Women aged 21-60 years
Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage.
Planning to undergo unilateral or bilateral mastectomy.
Planning to undergo nipple- or skin-sparing mastectomy.
Mastectomy weight less than 800 grams.
Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (≤ 4 cm) at the defect margins with otherwise adequate perfusion.

Exclusion Criteria:

Receipt of neoadjuvant chemotherapy for locally advanced breast cancer.
Presence of preoperative axillary lymph node metastasis.
Presence of intraoperative sentinel node positivity.
History of radiotherapy.
Current smoker.
Planning to undergo direct-to-implant reconstruction.
BMI >35.
Prior sternotomy.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT04716959

Recruitment Status:

Withdrawn

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

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Memorial Sloan Kettering BaskingRidge (Consent and Followup)
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent and Followup)
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent and Followup )
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent and Followup)
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent and Followup)
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent and Followup)
Rockville Centre New York, 11553, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT04716959

Recruitment Status:

Withdrawn

Sponsor:


Memorial Sloan Kettering Cancer Center

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