Phase
Condition
N/ATreatment
Delayed reconstruction
Delayed-immediate reconstruction
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 thestatus of estrogen receptor, progesterone receptor, malignancy grade, and HER2status.
The patient is a candidate for loco-regional radiation therapy according to nationalor institutional guidelines.
Highly selected patients with inflammatory breast cancer, namely those with completeor near complete response to neoadjuvant systemic thera-py judged by imaging andclinical examination before surgery. Any skin edema and clinical signs of skininvolvement must have disappeared during systemic therapy. It is highly recommendedthat the decision to offer an inflammatory breast cancer patient inclusion in theDBCG RT Recon trial is made during a multidisciplinary team conference.
Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatmentand other targeted therapies used in the adjuvant setting either as new standard oras part of a trial during the course of the trial is accepted.
Neoadjuvant chemotherapy and primary systemic therapy of an operable breast canceris accepted.
Patient with previous non-breast malignancy is accepted if the patient has beenwithout disease minimum 5 years, and the treating oncologist esti-mates a low riskof recurrence. Patients with the following diseases can be accepted despite lessthan 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situcoli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinomaof the skin.
Life expectancy minimum 10 years.
Exclusion
Exclusion Criteria:
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 (not including carcinoma in situ of the cervix orcolon, melanoma in situ, basal cell carcinoma of the skin, and squamous cellcarcinoma of the skin) within 5 years.
Conditions indicating that the patient cannot go through breast reconstruction, theradiation therapy or follow up.
Not being able to participate due to language or other personal issues.
Life expectancy less than 10 years.
Study Design
Study Description
Connect with a study center
Ålborg Universitetshospital
Aalborg,
DenmarkSite Not Available
Gentofte Hospital/Herlev Hospital
Copenhagen,
DenmarkActive - Recruiting
Rigshospitalet/Herlev Hospital
Copenhagen,
DenmarkActive - Recruiting
Esbjerg Sygehus
Esbjerg,
DenmarkSite Not Available
Ringsted Sygehus
Ringsted,
DenmarkSite Not Available
Sjællands Universitetshospital
Roskilde,
DenmarkSite Not Available
Vejle Sygehus
Vejle,
DenmarkSite Not Available
Viborg Sygehus
Viborg,
DenmarkSite Not Available
Åbenrå Sygehus
Åbenrå,
DenmarkSite Not Available
Århus Universitets Hospital
Århus,
DenmarkSuspended
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