An interventional study of Breast conserving surgery and Radical modified mastectomy in Inflammatory Breast Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast.
Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.
In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.
There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.
112 studies on the registry are indexed under Inflammatory Breast Neoplasms; 7 are open to participants now.
This study's planned enrollment of 300 is above the median of 58 across 96 interventional studies indexed under Inflammatory Breast Neoplasms.
Browse Inflammatory Breast Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Breast conserving surgery
Procedure: Radical modified mastectomy
Remove only a small part of the breast
Remove all the breast parenchyma, nipple and skin
local recurrence rate
Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy
Time frame: 24 months
local recurrence-free survival
Rate of disease free survival after breast conserving surgery vs radical mastectomy
Time frame: 24 months
overall survival
overall survival after breast conserving surgery vs radical mastectomy
Time frame: 24 months
Start is estimated for Mar 2024; primary completion for Jan 2026, 22 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Inflammatory Breast Neoplasms →
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