Breast Implant; Complications, Breast Neoplasm Female, Complication of Radiation Therapy
Conditions
Keywords
Breast cancer, Reconstruction, Post mastectomy radiotherapy
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
Interventions
PROCEDUREDelayed-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.
PROCEDUREDelayed reconstruction
Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT
Sponsors
Danish Breast Cancer Cooperative Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study started as a randomized trial but was november 2023 changed for a prospective single arm tieal
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 10 years post-final reconstruction | Degree of Depression measured by Becks Depression Inventory, BDII using a scale from 1 to 4, 4 being the worst |
| Fear of cancer recurrence | 10 years post-final reconstruction | Fear of cancer recurrence measured by Concerns About Recurrence Questionnaire-3 (CARQ-3 ) on a scale from 1 to 10, 10 worst (fear all the time) |
| Patient´s satisfaction and quality of life (QoL) | 10 years post-final reconstruction | Patient satisfaction and QoL measures by the BREAST-Q-instruments on a scale from 1 to 5, 5 being worst |
| Timely initiation of adjuvant therapy | 1 year | Time from primary surgery to start of adjuvant therapy |
| Number of patients with complications without surgical intervention | 1 year after final reconstruction | Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary |
| Number of patients with lymphoedema | 10 years post-final reconstruction | Difference in arm circumference between arms 15 cm/10 cm proximal/distal to the olecranon bilaterally. Any difference ≥10% defines lymhoedema. |
| Number of patients with restricted range of motion of the shoulder | 10 years post-final reconstruction | Differences between arms in range of motion of the shoulder measured at abduction/flexion with the patient sitting in front of a poster with a circle with degrees 0-180˚.Any difference ≥10 degrees defines defines restricted motion |
| Number of patients with capsular contracture | 10 years post-final reconstruction | Degree of capsular Contracture using Baker grading |
| Aesthetic outcome | 10 years post-final reconstruction | Aesthetic outcome scored bt the physician using breast Photo, on a scale from 0 to 3, 3 being worst |
| Degree of patient reported morbidity regarding body image, painsensory disturbanses and feeling og lymphoedema | 10 years post-final reconstruction | Patient reported morbidity measured by a questionnaire. The prevalence of pain will be assessed on a 0-10 numerical rating scale (NRS) and reported as: 'light pain' NRS 1-3; 'moderate pain' NRS 4-6; and 'severe pain' NRS 7-10. Sensory disturbances will be assessed by a dichotomous 'yes/no' question,. Lymphoedema will be assessed on a 0-10 numerical rating scale, 10 being worst. Body image will be assessed on a 0-7 numerical rating scale, 7 being best. |
Countries
Denmark
Contacts
Primary ContactTove F Tvedskov, DMSc
Backup ContactPeer M Christiansen, Professor
Outcome results
None listed