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.
Woman >18 years who are offered a mastectomy for invasive breast can-cer pT1-3, pN0-N3, M0 and wish reconstruction. The patient can be inclu-ded no matter the status of estrogen receptor, progesterone receptor, malignancy grade, and HER2 status.
The patient is a candidate for loco-regional radiation therapy according to national or institutional guidelines.
Highly selected patients with inflammatory breast cancer, namely those with complete or near complete response to neoadjuvant systemic thera-py judged by imaging and clinical examination before surgery. Any skin edema and clinical signs of skin involvement must have disappeared during systemic therapy. It is highly recommended that the decision to offer an inflammatory breast cancer patient inclusion in the DBCG RT Recon trial is made during a multidisciplinary team conference.
Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatment and other targeted therapies used in the adjuvant setting either as new standard or as part of a trial during the course of the trial is accepted.
Pregnant or lactating.
Previous breast cancer or Ductal carcinoma in Situ (DCIS).
Bilateral breast cancer.
Previous radiation therapy to the chest region.
Single group
Delayed-immediate reconstruction
Procedure/SurgerySkin 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.
Delayed reconstruction
Procedure/SurgeryTotal mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT
Number of patients with complications with surgical intervention
Number of patients with complication deeming surgical intervention necessary (excluding percutaneous drainage and antibiotic treatment for inflammation in cases without need for open drainage): * Infection * Hematoma * Loss of implant/expander * Necrosis * Seroma
Number of patients with complications without surgical intervention
Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary
Depression
Degree of Depression measured by Becks Depression Inventory, BDII using a scale from 1 to 4, 4 being the worst
Fear of cancer recurrence
Fear of cancer recurrence measured by Concerns About Recurrence Questionnaire-3 (CARQ-3 ) on a scale from 1 to 10, 10 worst (fear all the time)
Patient´s satisfaction and quality of life (QoL)
Patient satisfaction and QoL measures by the BREAST-Q-instruments on a scale from 1 to 5, 5 being worst
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