Actively Recruiting
Led by Danish Breast Cancer Cooperative Group · Updated on 2025-02-06
590
Participants Needed
8
Research Sites
521 weeks
Total Duration
This research aims to compare two methods of breast reconstruction in female breast cancer patients who undergo mastectomy followed by post-mastectomy radiation therapy (PMRT). The study evaluates the safety and outcomes of delayed-immediate reconstruction, where a skin-sparing mastectomy and implant reconstruction are done at the time of primary surgery to preserve native skin for later reconstruction, versus the standard delayed reconstruction which occurs 6 to 12 months after chemotherapy and PMRT. The goal is to assess complications, aesthetic results, and psychological well-being associated with each approach. Participants are assigned to one of two groups: the delayed-immediate reconstruction group receives a skin-sparing mastectomy with silicone implant or expander covered by muscle and mesh, followed by a final reconstruction 6 to 12 months after chemotherapy and radiation. The delayed reconstruction group undergoes total mastectomy initially and final reconstruction 6 to 12 months after PMRT using any reconstructive method. Contralateral procedures are allowed during delayed surgeries. This design allows comparison of complication rates and outcomes between the two approaches. Throughout the study, patients will be closely monitored for surgical complications requiring intervention within one year of final reconstruction. Secondary measures include complications not requiring surgery, patient depression, fear of cancer recurrence, satisfaction, quality of life, body image, pain, lymphoedema, shoulder mobility, capsular contracture, and aesthetic outcomes evaluated up to 10 years after reconstruction. Timely start of adjuvant therapy is also assessed. Participation involves surgery, follow-up visits, physical and psychological assessments over many years to evaluate safety and long-term effects.
CONDITIONS
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until completion of chemotherapy and radiation therapy, approximately 6 to 12 months
Participants undergo primary surgery with either delayed-immediate reconstruction involving skin sparing mastectomy and implant placement, or delayed reconstruction with total mastectomy. This is followed by chemotherapy and loco-regional radiation therapy as per guidelines.
Surgery and routine treatment visits as per standard care
Duration - 6 to 12 months post-chemotherapy and radiation
Participants receive final breast reconstruction surgery 6 to 12 months after completion of chemotherapy and radiation therapy using various reconstructive procedures.
1 to 2 visits for final reconstruction surgery and immediate post-operative care
Duration - Up to 10 years post-final reconstruction
Participants are monitored for complications, morbidity, aesthetic outcomes, psychological well-being, and quality of life for up to 10 years after final reconstruction.
Regular follow-up visits over 10 years
Total: 8 locations
1
Åbenrå Sygehus
Aabenraa, Denmark
Withdrawn
2
Ålborg Universitetshospital
Aalborg, Denmark
Withdrawn
3
Århus Universitets Hospital
Aarhus, Denmark
Suspended
4
Gentofte Hospital/Herlev Hospital
Copenhagen, Denmark
Actively Recruiting
5
Esbjerg Sygehus
Esbjerg, Denmark
Withdrawn
6
Sjællands Universitetshospital
Roskilde, Denmark
Not Yet Recruiting
7
Vejle Sygehus
Vejle, Denmark
Not Yet Recruiting
8
Viborg Sygehus
Viborg, Denmark
Withdrawn
T
Tove F Tvedskov, DMSc
P
Peer M Christiansen, Professor
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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O Kaidar-Person, H D Nissen, E S Yates...
https://pubmed.ncbi.nlm.nih.gov/32988717