Clinical trial NCT03730922: Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
Official title: The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm Female
Complication of Radiation Therapy
Breast Implant; Complications
Keywords: Breast cancer
Reconstruction
Post mastectomy radiotherapy
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 590
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study started as a randomized trial but was november 2023 changed for a prospective single arm tieal
Primary purpose: TREATMENT

Brief 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.

Detailed description: An increasing proportion of breast cancer patients treated by mastectomy wish for a breast reconstruction. If post-mastectomy radiation therapy is recommended, the reconstruction is often delayed until 6 - 12 months after completion of chemotherapy and radiation therapy due to risk of complication that might delay adjuvant treatment. At this time the native skin over the removed breast cannot be used in the reconstruction, resulting in a suboptimal aesthetic outcome. In the delayed-immediate reconstruction method, a skin sparing mastectomy and reconstruction with implant is performed at primary surgery, to save the native skin under radiation therapy, thereby improving the chance for a good aesthetic outcome at the final delayed reconstruction. In this trial breast cancer patients treated by mastectomy and loco-regional radiation therapy is randomized to either delayed reconstruction or delayed-immediate reconstruction. The complication rate as well as morbidity, aesthetic outcome and psychological well-being after delayed-immediate reconstruction will be compared with delayed reconstruction

Eligibility criteria: 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 outcomes:
measure: Number of patients with complications with surgical intervention
timeFrame: 1 year after final reconstruction
Secondary outcomes:
measure: Number of patients with complications without surgical intervention
timeFrame: 1 year after final reconstruction
measure: Depression
timeFrame: 10 years post-final reconstruction
measure: Fear of cancer recurrence
timeFrame: 10 years post-final reconstruction
measure: Patient´s satisfaction and quality of life (QoL)
timeFrame: 10 years post-final reconstruction
measure: Timely initiation of adjuvant therapy
timeFrame: 1 year
measure: Degree of patient reported morbidity regarding body image, painsensory disturbanses and feeling og lymphoedema
timeFrame: 10 years post-final reconstruction
measure: Number of patients with lymphoedema
timeFrame: 10 years post-final reconstruction
measure: Number of patients with restricted range of motion of the shoulder
timeFrame: 10 years post-final reconstruction
measure: Number of patients with capsular contracture
timeFrame: 10 years post-final reconstruction
measure: Aesthetic outcome
timeFrame: 10 years post-final reconstruction
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Ålborg Universitetshospital
city: Copenhagen
country: Denmark
facility: Gentofte Hospital/Herlev Hospital
city: Esbjerg
country: Denmark
facility: Esbjerg Sygehus
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Viborg
country: Denmark
facility: Viborg Sygehus
city: Åbenrå
country: Denmark
facility: Åbenrå Sygehus
city: Århus
country: Denmark
facility: Århus Universitets Hospital
Study officials:
affiliation: DBCG
name: Birgitte V Offersen, Professor
role: STUDY_DIRECTOR
affiliation: DBCG
name: Tove F Tvedskov, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: DBCG
name: Tine Damsgaard, Professor
role: STUDY_DIRECTOR
affiliation: DBCG
name: Peer Christiansen, Professor
role: STUDY_DIRECTOR
affiliation: DBCG
name: Majbrit Jensen, MSc
role: STUDY_DIRECTOR
References:
citation: Kaidar-Person O, Nissen HD, Yates ES, Andersen K, Boersma LJ, Boye K, Canter R, Costa E, Daniel S, Hol S, Jensen I, Lorenzen EL, Mjaaland I, Nielsen MEK, Poortmans P, Vikstrom J, Webb J, Offersen BV. Postmastectomy Radiation Therapy Planning After Immediate Implant-based Reconstruction Using the European Society for Radiotherapy and Oncology-Advisory Committee in Radiation Oncology Practice Consensus Guidelines for Target Volume Delineation. Clin Oncol (R Coll Radiol). 2021 Jan;33(1):20-29. doi: 10.1016/j.clon.2020.09.004. Epub 2020 Sep 26.