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

NCT03730922 | Recruiting

• 1 other identifier: DBCG RT Recon
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Keywords

Breast cancer; Reconstruction; Post mastectomy radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of patients with complications without surgical intervention

  1 year after final reconstruction

• Depression

  10 years post-final reconstruction

• Fear of cancer recurrence

  10 years post-final reconstruction

• Patient´s satisfaction and quality of life (QoL)

  10 years post-final reconstruction

• Timely initiation of adjuvant therapy

  1 year

Study Arms (2)

A: Delayed-immediate reconstruction

EXPERIMENTAL

Primary Surgery: Skin sparing mastectomy (nipple sparing if appropriate) and axillary surgery according to guidelines or protocol. Reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Delayed reconstruction: Final reconstruction with any reconstructive procedure - being it autologous or implant-based (one- or two-stage, +/- acellular dermal matrix (ADM)) - is performed 6-12 months after completion of chemotherapy and PMRT. Any contralateral procedure is allowed when doing the delayed surgery, but not in relation to the initial cancer surgery.

Procedure: Delayed-immediate reconstruction

B: Delayed reconstruction

ACTIVE COMPARATOR

Primary surgery: Total mastectomy and axillary surgery according to guidelines or protocol. Delayed reconstruction: 6-12 months after completion of PMRT: final recon-struction with any reconstructive procedure - being it autologous or implant-based (one-or two-stage, +/- ADM). Any contralateral procedure is allowed at any time point after PMRT has been delivered This arm has been closed nov 2023

Procedure: Delayed reconstruction

Interventions

Delayed-immediate reconstruction PROCEDURE

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.

A: Delayed-immediate reconstruction

Delayed reconstruction PROCEDURE

Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT

B: Delayed reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Breast Cancer Cooperative Group: lead

Study Sites (8)

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

Related Publications (1)

• 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.

  PMID: 32988717 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Birgitte V Offersen, Professor

  DBCG

  STUDY DIRECTOR

• Tove F Tvedskov, DMSc

  DBCG

  PRINCIPAL INVESTIGATOR

• Tine Damsgaard, Professor

  DBCG

  STUDY DIRECTOR

• Peer Christiansen, Professor

  DBCG

  STUDY DIRECTOR

• Majbrit Jensen, MSc

  DBCG

  STUDY DIRECTOR

Central Study Contacts

Tove F Tvedskov, DMSc

CONTACT

+4535451028; tove.holst.filtenborg.tvedskov@regionh.dk

Peer M Christiansen, Professor

CONTACT

peerchri@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, DMSc, Phd, associated professor

Model Details: The study started as a randomized trial but was november 2023 changed for a prospective single arm tieal

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: November 5, 2018
• Study Start: January 1, 2020
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2035
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

DK (8)