NCT03730922 Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
| NCT ID | NCT03730922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danish Breast Cancer Cooperative Group |
| Condition | Breast Neoplasm Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 590 participants in total. It began in 2020-01-01 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Birgitte V Offersen, Professor
STUDY DIRECTOR
DBCG
Frequently Asked Questions
Who can join the NCT03730922 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasm Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03730922 currently recruiting?
Yes, NCT03730922 is actively recruiting participants. Contact the research team at tove.holst.filtenborg.tvedskov@regionh.dk for enrollment information.
Where is the NCT03730922 trial being conducted?
This trial is being conducted at Aabenraa, Denmark, Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark and 4 additional locations.
Who is sponsoring the NCT03730922 clinical trial?
NCT03730922 is sponsored by Danish Breast Cancer Cooperative Group. The principal investigator is Birgitte V Offersen, Professor at DBCG. The trial plans to enroll 590 participants.