Partial Breast Re-irradiation in Women in Women With Locally Recurrent Breast Cancer Previously Treated With Conservative Surgery and Whole Breast Irradiation

Study Overview
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Brief Summary
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A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer

Detailed Description
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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.

Official Title
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Partial Breast Re-irradiation in Women With Locally Recurrent Breast Cancer Previously Treated With Conservative Surgery and Whole Breast Irradiation: A Prospective Phase II Clinical Study

Conditions
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Breast Cancer, Recurrent

Intervention / Treatment
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* Radiation: Partial breast re-irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated ipsilateral unifocal breast lesions; Histologically confirmed invasive breast carcinoma or carcinoma in situ; Limited size (< 2 cm) without evidence of skin involvement; Negative histologic margins of resection; Negative axillary lymph nodes; No synchronous distant metastases; Bilateral breast mammogram or MRI within 120 days prior to study entry; For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) Positron Emission Tomography -Computerized Tomography scan or Computerized Tomography scan of the chest, abdomen, and pelvis, and bone scan; ≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence; 10. Female, aged >18 years; 11. Life expectancy of greater than 12 months; 12. Eastern Cooperative Oncology Group (ECOG) performance status <2; 13. Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter; 14. Participant is willing and able to give informed consent for participation in the study; Exclusion Criteria: Regional recurrences (axillary, supraclavicular); Positive histologic margins at resection; Metastatic disease; Previous breast Radiotherapy performed with Intraoperative radiotherapy, brachytherapy or previous partial breast treatment; Known pathogenic mutation of BRCA1, BRCA2 or Tumor Protein 53 gene; Patients who had chemotherapy within 2 weeks prior to study Radiotherapy; Participation in another clinical trial with any investigational agents within 30 days prior to study screening; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; Significant comorbidity precluding radiotherapy for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus); 10. Other known malignant neoplastic diseases in the patient's medical history with a disease free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix, endometrium or colon); 11. Inaccessibility for follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partial breast re-irradiation<br>partial breast re-irradiation in patients with local recurrence of breast cancer, previously treated with breast conservative surgery and whole breast radiotherapy. A total dose of 35 Gy in 10 daily fractions, 5 fractions per week, will be prescribed. | Radiation: Partial breast re-irradiation<br>* partial breast re-irradiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Overall survival | Overall survival is defined as time from registration to date of death or last follow-up | 5 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial re-irradiation, recurrent breast cancer, conservative surgery