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

Launched by DANISH BREAST CANCER COOPERATIVE GROUP · Nov 2, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to breast reconstruction for women who have undergone a mastectomy and radiation therapy due to breast cancer. Traditionally, reconstruction is delayed for 6 to 12 months after treatment to reduce the risk of complications. However, this trial is looking at a method called delayed-immediate reconstruction, where doctors perform a skin-sparing mastectomy and place a silicone implant right away to preserve the skin for a later reconstruction. The goal is to see if this method is safe and effective for patients.

To be eligible for this trial, participants must be women over 18 years old who are scheduled for a mastectomy due to invasive breast cancer. They should also be candidates for radiation therapy. Patients who have inflammatory breast cancer that has responded well to treatment may also be included. Those with certain previous cancers or health conditions may not qualify. If you join the trial, you can expect to receive specialized care and regular follow-ups as part of the study. This trial is currently recruiting participants, so if you think you might be eligible, it could be a great opportunity to explore new options for your breast reconstruction.

Gender

FEMALE

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.