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Breast Neoplasm FemaleNCT03730922

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

A study testing Delayed-immediate reconstruction and Delayed reconstruction in people with Breast Neoplasm Female and Complication of Radiation Therapy, run by Danish Breast Cancer Cooperative Group at 8 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Delayed-immediate reconstruction and Delayed reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
590 participants
Where
8 sitesDenmark
Study dates
1 Jan 2020to Nov 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tove F Tvedskov, DMSc contact

+4535451028

tove.holst.filtenborg.tvedskov@regionh.dk

Peer M Christiansen, Professor contact

peerchri@rm.dk

8 sites in 1 country

Denmark8 sites, 3 recruiting

  • Åbenrå Sygehus

    Aabenraa

    Withdrawn

  • Ålborg Universitetshospital

    Aalborg

    Withdrawn

  • Århus Universitets Hospital

    Aarhus

    Suspended

  • Gentofte Hospital/Herlev Hospital

    Copenhagen

    Tove Tvedskov

    Rikke Bredgaard

    Recruiting

  • Esbjerg Sygehus

    Esbjerg

    Withdrawn

  • Sjællands Universitetshospital

    Roskilde

    Lone Bak Hansen

    Not yet recruiting

  • Vejle Sygehus

    Vejle

    Tine Damsgaard, Professor

    Not yet recruiting

  • Viborg Sygehus

    Viborg

    Withdrawn

Other trials in Denmark

About this study

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

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.

Read the 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

Being tested
Delayed-immediate reconstruction, Delayed reconstruction
Keywords
Breast cancer, Reconstruction, Post mastectomy radiotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delayed-immediate reconstructionProcedure or surgery

    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 reconstructionProcedure or surgery

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

Study groups in NCT03730922
Study groupRoleWhat they receive
A: Delayed-immediate reconstructionExperimentalPrimary 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.
Receives: Procedure: Delayed-immediate reconstruction
B: Delayed reconstructionActive comparatorPrimary 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
Receives: Procedure: Delayed reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year after final reconstruction

Secondary outcomes (10)

  1. Number of patients with complications without surgical intervention

    Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary

    Measured: 1 year after final reconstruction

  2. Depression

    Degree of Depression measured by Becks Depression Inventory, BDII using a scale from 1 to 4, 4 being the worst

    Measured: 10 years post-final reconstruction

  3. 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)

    Measured: 10 years post-final reconstruction

  4. 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

    Measured: 10 years post-final reconstruction

  5. Timely initiation of adjuvant therapy

    Time from primary surgery to start of adjuvant therapy

    Measured: 1 year

  6. 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.

    Measured: 10 years post-final reconstruction

  7. 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.

    Measured: 10 years post-final reconstruction

  8. 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

    Measured: 10 years post-final reconstruction

  9. Number of patients with capsular contracture

    Degree of capsular Contracture using Baker grading

    Measured: 10 years post-final reconstruction

  10. Aesthetic outcome

    Aesthetic outcome scored bt the physician using breast Photo, on a scale from 0 to 3, 3 being worst

    Measured: 10 years post-final reconstruction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2018
  2. Study start1 Jan 2020
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
The study started as a randomized trial but was november 2023 changed for a prospective single arm tieal
Masking
None (open label)
Enrolment
590 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03730922
Sponsor's protocol ID
DBCG RT Recon
Status last verified
Feb 2025
First submitted
2 Oct 2018
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32988717

Questions about this trial

What is this clinical trial studying?

A study testing Delayed-immediate reconstruction and Delayed reconstruction in people with Breast Neoplasm Female and Complication of Radiation Therapy, run by Danish Breast Cancer Cooperative Group at 8 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tove F Tvedskov, DMSc (+4535451028, tove.holst.filtenborg.tvedskov@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with complications with surgical intervention (time frame: 1 year after final reconstruction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03730922, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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