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Compares treatment options for Breast Neoplasm Female
Official title Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
ClinicalTrials.gov ID: NCT03730922
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
- Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatment and other targeted therapies used in the adjuvant setting either...
- Neoadjuvant chemotherapy and primary systemic therapy of an operable breast cancer is accepted.
You likely can't join if
- 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...
- Conditions indicating that the patient cannot go through breast reconstruction, the radiation therapy or follow up.
See the full eligibility 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...
- 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...
- 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...
- 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...
- Life expectancy minimum 10 years.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aabenraa, Denmark
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Esbjerg, Denmark
- Roskilde, Denmark
- Vejle, Denmark
- Viborg, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aabenraa, Denmark; Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Esbjerg, Denmark; Roskilde, Denmark and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.