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RECRUITINGINTERVENTIONAL

Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.

Who May Be Eligible (Plain English)

Who May Qualify: Women \>18 years with histopathologically-confirmed breast cancer, who: - require mastectomy for any reason - a known indication for (adjuvant) radiotherapy - require implant-based breast reconstruction Who Should NOT Join This Trial: - Inability to give willing to sign a consent form - MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings - Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla - Pregnant or lactating - inflammatory breast cancer Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Women \>18 years with histopathologically-confirmed breast cancer, who: * require mastectomy for any reason * a known indication for (adjuvant) radiotherapy * require implant-based breast reconstruction Exclusion Criteria: * Inability to give informed consent * MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings * Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla * Pregnant or lactating * inflammatory breast cancer

Treatments Being Tested

RADIATION

Neoadjuvant radiotherapy

In case of neoadjuvant chemotherapy, RT will start 3-4 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions or 16 x 2.67Gy 5 fractions per week. A skin-sparing mastectomy and a immediate implant-based breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment.

Locations (1)

Xinhong Wu
Wuhan, Hubei, China