Comparing two methods of breast reconstruction after mastectomy and radiation therapy
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
This study is testing whether a new method of breast reconstruction done right after surgery can lead to better results and fewer problems for women who have had a mastectomy and radiation for breast cancer, compared to the traditional method done later.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Danish Breast Cancer Cooperative Group Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 8 sites (Aabenraa and 7 other locations) |
| Trial ID | NCT03730922 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and outcomes of delayed-immediate breast reconstruction versus traditional delayed reconstruction in women undergoing mastectomy and post-mastectomy radiation therapy for breast cancer. The delayed-immediate method involves performing a skin-sparing mastectomy and immediate reconstruction with a silicone implant, aiming to preserve the native skin for better aesthetic results. Participants will be randomized to receive either reconstruction method, and outcomes such as complication rates, morbidity, aesthetic satisfaction, and psychological well-being will be assessed. The goal is to determine if the delayed-immediate approach can improve overall patient outcomes compared to the delayed reconstruction method.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old who are undergoing mastectomy for invasive breast cancer and are candidates for loco-regional radiation therapy.
Not a fit: Patients who do not wish to undergo reconstruction or those with significant skin involvement at the time of surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved aesthetic outcomes and reduced complications for breast cancer patients undergoing reconstruction after mastectomy and radiation therapy.
How similar studies have performed: Other studies have explored various reconstruction methods, but this specific approach of delayed-immediate reconstruction in the context of radiation therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aabenraa and 7 other locations
- 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)
Study contacts
- Principal investigator: Tove F Tvedskov, DMSc — Dbcg
- Study coordinator: Tove F Tvedskov, DMSc
- Email: tove.holst.filtenborg.tvedskov@regionh.dk
- Phone: +4535451028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.