Status:
ACTIVE_NOT_RECRUITING
Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.
Lead Sponsor:
Fundacao Champalimaud
Collaborating Sponsors:
European Commission
INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (...
Detailed Description
The CINDERELLA clinical trial will be an open, prospective randomized trial that Champalimaud Foundation will coordinate. Five clinical centres agreed to participate in the trial. The trial will be de...
Eligibility Criteria
Inclusion
- Inclusion :
- More than 18 years old
- Written informed consent
- Primary breast cancer in situ or invasive without evidence of systemic disease - non Stage IV or locally advanced non-operable breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Uni or Bilateral surgery even if prophylactic in one side
- Capacity to use a web-based app autonomously or with home-based support
- Exclusion:
- Mastectomy without reconstruction
- Pregnancy or lactation
- Previous radiation to breast/chest (e.g., lymphoma)
- Previous ipsilateral breast surgery due to malignant disease.
- Other neoplasm in the last 5 years (excluding basal cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix)
- Severe skin disease that will contra-indicate the use of radiotherapy
- Prophylactic surgery
Exclusion
Key Trial Info
Start Date :
August 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1030 Patients enrolled
Trial Details
Trial ID
NCT05196269
Start Date
August 8 2023
End Date
December 1 2026
Last Update
May 7 2025
Active Locations (6)
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1
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
2
Sheba Medical Center
Ramat Gan, Israel, 52621
3
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
4
Copernicus Mamma Centrum, Wojewodzkie Centrum Onkologii, Copernicus Podmiot Leczniczy
Gdansk, Pomeranian, Poland, 80-210