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

  • STATUS
    Recruiting
  • End date
    Nov 26, 2033
  • participants needed
    590
  • sponsor
    Danish Breast Cancer Cooperative Group
Updated on 26 August 2021
cancer
estrogen
carcinoma
breast cancer
endocrine therapy
progesterone
aspart
mastectomy
mates

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.

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

Details
Condition Breast Neoplasm Female, Breast Implant; Complications, Complication of Radiation Therapy
Treatment Delayed-immediate reconstruction, Delayed reconstruction
Clinical Study IdentifierNCT03730922
SponsorDanish Breast Cancer Cooperative Group
Last Modified on26 August 2021

Eligibility

Yes No Not Sure

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
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