Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

Breast Neoplasm Female Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730922
• Other study ID #: DBCG RT Recon
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 2035

Study information

• Verified date: November 2023
• Source: Danish Breast Cancer Cooperative Group
• Contact: Tove F Tvedskov, DMSc
• Phone: +4535451028
• Email: tove.holst.filtenborg.tvedskov[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 590
• Est. completion date: November 2035
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Implant; Complications
• Breast Neoplasm Female
• Breast Neoplasms
• Complication of Radiation Therapy

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Denmark	Ålborg Universitetshospital	Aalborg
Denmark	Åbenrå Sygehus	Åbenrå
Denmark	Århus Universitets Hospital	Århus
Denmark	Gentofte Hospital/Herlev Hospital	Copenhagen
Denmark	Esbjerg Sygehus	Esbjerg
Denmark	Sjællands Universitetshospital	Roskilde
Denmark	Vejle Sygehus	Vejle
Denmark	Viborg Sygehus	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Danish Breast Cancer Cooperative Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complications with surgical intervention	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	1 year after final reconstruction
Secondary	Number of patients with complications without surgical intervention	Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary	1 year after final reconstruction
Secondary	Depression	Degree of Depression measured by Becks Depression Inventory, BDII using a scale from 1 to 4, 4 being the worst	10 years post-final reconstruction
Secondary	Fear of cancer recurrence	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)	10 years post-final reconstruction
Secondary	Patient´s satisfaction and quality of life (QoL)	Patient satisfaction and QoL measures by the BREAST-Q-instruments on a scale from 1 to 5, 5 being worst	10 years post-final reconstruction
Secondary	Timely initiation of adjuvant therapy	Time from primary surgery to start of adjuvant therapy	1 year
Secondary	Degree of patient reported morbidity regarding body image, painsensory disturbanses and feeling og lymphoedema	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.	10 years post-final reconstruction
Secondary	Number of patients with lymphoedema	Difference in arm circumference between arms 15 cm/10 cm proximal/distal to the olecranon bilaterally. Any difference =10% defines lymhoedema.	10 years post-final reconstruction
Secondary	Number of patients with restricted range of motion of the shoulder	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	10 years post-final reconstruction
Secondary	Number of patients with capsular contracture	Degree of capsular Contracture using Baker grading	10 years post-final reconstruction
Secondary	Aesthetic outcome	Aesthetic outcome scored bt the physician using breast Photo, on a scale from 0 to 3, 3 being worst	10 years post-final reconstruction