RecruitingNot ApplicableNCT03730922

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

The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial

Sponsor

Danish Breast Cancer Cooperative Group

Enrollment

590 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasm Female Complication of Radiation Therapy Breast Implant; Complications

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of breast reconstruction approaches — one that begins immediately after mastectomy and radiation versus one that is fully delayed — to find out which gives better results for women with breast cancer who need both mastectomy and radiation therapy. **You may be eligible if...** - You are a woman over 18 who is scheduled for a mastectomy for invasive breast cancer (stage T1–T3) - You want to have breast reconstruction - You are recommended to have radiation therapy to the breast area after surgery - You may have any hormone receptor or HER2 status **You may NOT be eligible if...** - You have cancer that has spread to other organs (distant metastasis) - You have inflammatory breast cancer without a good response to pre-treatment - You are not a candidate for breast reconstruction for medical reasons - You are not willing to follow the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDelayed-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.

PROCEDUREDelayed reconstruction

Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT