An interventional study of Hypofractionation in Breast Cancer, sponsored by Barretos Cancer Hospital. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-08.
Sponsored by Barretos Cancer Hospital · Not applicable, Interventional, and Treatment
RATIONALE:
Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome.
There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis.
PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.
General aim: To evaluated if hypofractionated accelerated radiotherapy in patients with breast cancer undergoing immediate breast implant reconstruction surgery is non inferior to conventional radiotherapy.
Aim 1 (Primary objective): Assess the G3 toxicity rate - loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning).
Aim 2 (Specific secondary objectives):
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Barretos Cancer Hospital is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Post Mastectomy Hypofractionated Radiotherapy Arm
Radiation: Hypofractionation
Post Mastectomy Conventional Radiotherapy
Hypofractionation scheme will comprise 40 Gy in 15 fractions
Assess the G3 toxicity rate
loss of the prosthesis (complication that requires surgical intervention: capsular contracture, leakage, infection, malpositioning)
Time frame: 2 years
Local recurrence
Compare local recurrence rate between two groups
Time frame: 5 years
Assessment of quality of life through the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire
Compare quality of life index between two groups using EORTC scales during treatment, after 6 and 12 months after treatment ending
Time frame: 2 years
Comparison of self-image using the EORTC Questionnaires European Organization for Research and Treatment of Cancer, where a high or low score may suggest good quality of life depending on the domain of the questionnaire
Compare self-image differences between groups
Time frame: 5 years
Compare acute and late radiodermatitis rates by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Acute and late radiodermatitis rateswill be evaluated by CTCAE 4.0 scale, using the adverse event (AE) reporting. A grading (severity) scale is provided for each AE term.
Time frame: 2 years
Dosimetric analysis
Analyze dosimetric planning differences considering the volumes of all breast and breast without prosthesis
Time frame: 5 years
Inflammation markers screening - detection of cytokines with the CBA panel
Study inflammation molecular markers, which may indicate an increased risk of fibrosis. The cytokines present in the plasma will be evaluated using the Cytometric Beads Array technique with the CBA panel - Human Th1/Th2/Th17CBAKit which, through beads, is able to identify the expression of cytokines expressed by Th1, Th2 standard lymphocytes and Th17, including IL-2, IL-4, IL-6, IL-10, IL-17A, TNF e IFN-γ. After proper labeling, the immunophenotypic analyzes will be performed in a BD FAC Symphony flow cytometer.
Time frame: 3 years
Extracellular vesicles isolation and characterization
Evaluate the change in the profile of extracellular vesicles in patients treated with RT hypofractionated and conventional
Time frame: 4 years
Evaluate extracellular vesicles molecular profile
Evaluate the change in EV collagen production after in vitro irradiation, using co-culture experiments with breast cells and fibroblasts
Time frame: 4 years
Started Jun 2022 (actual). Primary completion is estimated for May 2026, 46 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 46 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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Barretos Cancer Hospital