Delayed-immediate reconstruction: Skin 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: Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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.
* Neoadjuvant chemotherapy and primary systemic therapy of an operable breast cancer is accepted.
* Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist esti-mates a low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situ coli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinoma of the skin.
* Life expectancy minimum 10 years.
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 or colon, melanoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin) within 5 years.
* Conditions indicating that the patient cannot go through breast reconstruction, the radiation therapy or follow up.
* Not being able to participate due to language or other personal issues.
* Life expectancy less than 10 years.
Primary outcome measure(s)
Number of patients with complications with surgical intervention — 1 year after final reconstruction 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
Trial sites (8)
Facility
City
Region
Status
Åbenrå Sygehus
Aabenraa
Denmark
Withdrawn
Ålborg Universitetshospital
Aalborg
Denmark
Withdrawn
Århus Universitets Hospital
Aarhus
Denmark
Suspended
Gentofte Hospital/Herlev Hospital
Copenhagen
Denmark
Recruiting
Esbjerg Sygehus
Esbjerg
Denmark
Withdrawn
Sjællands Universitetshospital
Roskilde
Denmark
Not Yet Recruiting
Vejle Sygehus
Vejle
Denmark
Not Yet Recruiting
Viborg Sygehus
Viborg
Denmark
Withdrawn
More Danish Breast Cancer Cooperative Group trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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