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

NCT ID: NCT03730922

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 590 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2035-11-30

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Delayed-immediate reconstruction

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.

Group Type: EXPERIMENTAL

Delayed-immediate reconstruction

Intervention Type: 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.

B: Delayed reconstruction

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

Group Type: ACTIVE_COMPARATOR

Delayed reconstruction

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Delayed reconstruction

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Danish Breast Cancer Cooperative Group

OTHER

Sponsor Role: lead

Responsible Party

Tove Filtenborg Tvedskov

Consultant, DMSc, Phd, associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birgitte V Offersen, Professor

Role: STUDY_DIRECTOR

DBCG

Tove F Tvedskov, DMSc

Role: PRINCIPAL_INVESTIGATOR

DBCG

Tine Damsgaard, Professor

Role: STUDY_DIRECTOR

DBCG

Peer Christiansen, Professor

Role: STUDY_DIRECTOR

DBCG

Majbrit Jensen, MSc

Role: STUDY_DIRECTOR

DBCG

Locations

Åbenrå Sygehus

Aabenraa, , Denmark

Site Status: WITHDRAWN

Ålborg Universitetshospital

Aalborg, , Denmark

Site Status: WITHDRAWN

Århus Universitets Hospital

Aarhus, , Denmark

Site Status: SUSPENDED

Gentofte Hospital/Herlev Hospital

Copenhagen, , Denmark

Site Status: RECRUITING

Esbjerg Sygehus

Esbjerg, , Denmark

Site Status: WITHDRAWN

Sjællands Universitetshospital

Roskilde, , Denmark

Site Status: NOT_YET_RECRUITING

Vejle Sygehus

Vejle, , Denmark

Site Status: NOT_YET_RECRUITING

Viborg Sygehus

Viborg, , Denmark

Site Status: WITHDRAWN

Countries

Denmark

Central Contacts

Tove F Tvedskov, DMSc

Role: CONTACT

tove.holst.filtenborg.tvedskov@regionh.dk

+4535451028

Peer M Christiansen, Professor

Role: CONTACT

peerchri@rm.dk

Facility Contacts

Tove Tvedskov

Role: primary

Lone Bak Hansen

Role: primary

Tine Damsgaard, Professor

Role: primary

References

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.

Reference Type: DERIVED

PMID: 32988717 (View on PubMed)

Other Identifiers

DBCG RT Recon

Identifier Type: -

Identifier Source: org_study_id