Actively Recruiting
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
Led by Danish Breast Cancer Cooperative Group · Updated on 2025-02-06
590
Participants Needed
8
Research Sites
826 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman >18 years who are offered a mastectomy for invasive breast cancer pT1-3, pN0-N3, M0 and wish reconstruction
- Candidate for loco-regional radiation therapy according to guidelines
- Highly selected inflammatory breast cancer patients with near complete response to therapy and no skin involvement
- Accepts adjuvant systemic therapies including chemotherapy, endocrine, anti-HER2, and targeted treatments
- Accepts neoadjuvant chemotherapy and primary systemic therapy for operable breast cancer
- Previous non-breast malignancy allowed if disease free for at least 5 years, except certain in situ or skin cancers
- Life expectancy of minimum 10 years
You will not qualify if you...
- Pregnant or lactating
- Previous breast cancer or ductal carcinoma in situ (DCIS)
- Bilateral breast cancer
- Previous radiation therapy to the chest region
- Previous non-breast malignancy within 5 years, except certain in situ or skin cancers
- Conditions preventing breast reconstruction, radiation therapy, or follow-up
- Inability to participate due to language or personal issues
- Life expectancy less than 10 years
AI-Screening
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Trial Site Locations
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Withdrawn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Withdrawn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
Research Team
T
Tove F Tvedskov, DMSc
CONTACT
P
Peer M Christiansen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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