Actively Recruiting
Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2024-09-19
68
Participants Needed
1
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer
CONDITIONS
Official Title
Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Isolated ipsilateral unifocal breast lesions
- Histologically confirmed invasive breast carcinoma or carcinoma in situ
- Lesion size less than 2 cm without 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, whole-body PET-CT or CT chest/abdomen/pelvis and bone scan within 120 days prior to study entry if clinically relevant
- At least 24 months interval between initial breast conserving therapy and recurrence
- Female, aged over 18 years
- Life expectancy greater than 12 months
- ECOG performance status less than 2
- Female participants of childbearing potential must use effective contraception during study and for 4 months after
- Willing and able to give informed consent for participation
You will not qualify if you...
- Regional recurrences in axillary or supraclavicular areas
- Positive histologic margins at resection
- Metastatic disease
- Previous breast radiotherapy with IORT, brachytherapy, or partial breast treatment
- Known pathogenic mutation of BRCA1, BRCA2, or TP53 genes
- Chemotherapy within 2 weeks prior to study radiotherapy
- Participation in another clinical trial with investigational agents within 30 days prior to screening
- Uncontrolled illnesses including infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Significant comorbidities that contraindicate breast radiotherapy such as cardiovascular or pulmonary disease, scleroderma, or systemic lupus erythematosus
- Other malignant cancers in medical history with disease-free interval under 5 years (except treated basal cell carcinoma or in situ carcinomas of cervix, endometrium, or colon)
- Inaccessibility for follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UO Radioterapia, IRST IRCCS
Meldola, Forlì Cesena, Italy, 47014
Actively Recruiting
Research Team
O
Oriana Nanni
CONTACT
B
Bernadette Vertogen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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