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

Last updated: February 4, 2025
Sponsor: Danish Breast Cancer Cooperative Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Delayed reconstruction

Delayed-immediate reconstruction

Clinical Study ID

NCT03730922
DBCG RT Recon
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 thestatus of estrogen receptor, progesterone receptor, malignancy grade, and HER2status.

  • The patient is a candidate for loco-regional radiation therapy according to nationalor institutional guidelines.

  • Highly selected patients with inflammatory breast cancer, namely those with completeor near complete response to neoadjuvant systemic thera-py judged by imaging andclinical examination before surgery. Any skin edema and clinical signs of skininvolvement must have disappeared during systemic therapy. It is highly recommendedthat the decision to offer an inflammatory breast cancer patient inclusion in theDBCG RT Recon trial is made during a multidisciplinary team conference.

  • Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatmentand other targeted therapies used in the adjuvant setting either as new standard oras part of a trial during the course of the trial is accepted.

  • Neoadjuvant chemotherapy and primary systemic therapy of an operable breast canceris accepted.

  • Patient with previous non-breast malignancy is accepted if the patient has beenwithout disease minimum 5 years, and the treating oncologist esti-mates a low riskof recurrence. Patients with the following diseases can be accepted despite lessthan 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situcoli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinomaof the skin.

  • Life expectancy minimum 10 years.

Exclusion

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 orcolon, melanoma in situ, basal cell carcinoma of the skin, and squamous cellcarcinoma of the skin) within 5 years.

  • Conditions indicating that the patient cannot go through breast reconstruction, theradiation therapy or follow up.

  • Not being able to participate due to language or other personal issues.

  • Life expectancy less than 10 years.

Study Design

Total Participants: 590
Treatment Group(s): 2
Primary Treatment: Delayed reconstruction
Phase:
Study Start date:
January 01, 2020
Estimated Completion Date:
November 30, 2035

Study 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

Connect with a study center

  • Ålborg Universitetshospital

    Aalborg,
    Denmark

    Site Not Available

  • Gentofte Hospital/Herlev Hospital

    Copenhagen,
    Denmark

    Active - Recruiting

  • Rigshospitalet/Herlev Hospital

    Copenhagen,
    Denmark

    Active - Recruiting

  • Esbjerg Sygehus

    Esbjerg,
    Denmark

    Site Not Available

  • Ringsted Sygehus

    Ringsted,
    Denmark

    Site Not Available

  • Sjællands Universitetshospital

    Roskilde,
    Denmark

    Site Not Available

  • Vejle Sygehus

    Vejle,
    Denmark

    Site Not Available

  • Viborg Sygehus

    Viborg,
    Denmark

    Site Not Available

  • Åbenrå Sygehus

    Åbenrå,
    Denmark

    Site Not Available

  • Århus Universitets Hospital

    Århus,
    Denmark

    Suspended

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