Recruiting

Breast Reconstruction Methods and Patient Satisfaction After Mastectomy

Plain-English translation of NCT04356235 on ClinicalTrials.gov ↗ · Source last updated April 2020 · Translation generated August 2026 · How we translate trials

What is this trial?

This study is testing different surgical techniques for rebuilding the breast after mastectomy (surgical removal of breast tissue). Researchers want to understand which approaches give patients the best cosmetic results and highest satisfaction. The trial involves comparing several methods: some use tissue expanders followed by silicone implants, some also reshape the remaining breast for balance, and some test using supportive mesh alongside implants.

After breast cancer surgery, many women need breast reconstruction to restore appearance and confidence. Doctors have several surgical options available, but it's unclear which combination of techniques produces the best long-term results and highest patient satisfaction. This study will help guide future treatment decisions.

Do you qualify?

You likely qualify if…

you are under age 65 and have been diagnosed with primary breast cancer (Stage 0-III) requiring mastectomy
you are willing to undergo immediate or delayed breast reconstruction using implants
you are willing to participate in follow-up visits and cosmetic assessments over several years
you have not had prior breast surgery (such as cosmetic surgery or lifting) or radiation therapy to the breast area
you do not have autoimmune diseases or other serious health conditions that would limit life expectancy

You likely don't qualify if…

you are 65 years old or older, or have poor general health with an estimated life expectancy of less than 2 years
you have a history of other cancers (apart from non-melanoma skin cancer)
you have had previous breast surgery, radiation therapy to the breast, or reconstruction
you have autoimmune diseases, long-term steroid use that has affected skin quality, or severe complications from cancer treatment
you are unable or unwilling to commit to regular follow-up appointments for 5 years

What participation looks like

Participants will undergo mastectomy with one of several breast reconstruction approaches—either immediate reconstruction in one surgery, or a two-step process using a tissue expander first followed by implant placement. Depending on which group you're assigned to, your surgeon may also reshape or augment your other breast to match. You'll be followed closely with multiple appointments over 5 years, during which doctors will photograph your breasts, assess results, and ask you to complete surveys about satisfaction and quality of life.

AI-generated summary from trial data · Aug 11, 2026 · Not medical advice

Trial locations(1 site)

Hungary

National Institute of Oncology, Budapest