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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05772390
Other study ID # IRST174.25
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 31, 2023
Est. completion date March 2032

Study information

Verified date April 2023
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Oriana Nanni
Phone +390543739266
Email oriana.nanni@irst.emr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer


Description:

Breast cancer is the leading type of cancer in women worldwide. Although advances in treatment have led to an overall reduction in breast cancer mortality, survivors continue to have an ongoing risk of disease recurrence. For women who experience breast recurrence, mastectomy has historically been the only treatment approach offered. However, it has been associated with negative health outcomes, including reduced quality of life, depression and anxiety, and impaired sexual functioning. As a result, there is increasing interest to identify treatment options that include breast preservation. Breast-conserving surgery followed by re-irradiation with partial breast irradiation has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation.


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Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Partial breast re-irradiation
partial breast re-irradiation

Locations

Country Name City State
Italy UO Radioterapia, IRST IRCCS Meldola Forlì Cesena

Sponsors (1)

Lead Sponsor Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment related toxicity determine the toxicity of partial breast re-irradiation (PBrI) as rate of grade = 3 treatment-related skin, fibrosis, and breast pain Adverse Events, accordin to Common Terminology Criteria for Adverse Events scale 5.0 (Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE) up to 1 year from completion of radiation treatment 12 months
Secondary in-breast recurrence in the ipsilateral breast In-breast recurrence is defined histologic evidence of recurrent carcinoma, invasive or noninvasive (excluding lobular carcinoma in situ), in the ipsilateral breast 5 years
Secondary Number of patients free from mastectomy over total number of patients Freedom from mastectomy is calculated from mastectomy failure rates. Failure is a mastectomy of the treated breast performed for any reason 5 years
Secondary To evaluate distant-metastasis free survival Distant metastasis-free survival is defined as time from registration to the appearance of a distant metastasis confirmed radiographically and/or pathologically or death from any cause 5 years
Secondary Overall survival Overall survival is defined as time from registration to date of death or last follow-up 5 years
Secondary Patient satisfaction Patients satisfaction is assessed with the Breast-Q questionnaire (from 0 (worst) to 100 (best). Higher scores reflect a better outcome) 5 years
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