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Trial Title:
Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation
NCT ID:
NCT05772390
Condition:
Breast Cancer
Recurrent
Conditions: Official terms:
Breast Neoplasms
Recurrence
Conditions: Keywords:
Partial re-irradiation
recurrent breast cancer
conservative surgery
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Partial breast re-irradiation
Description:
partial breast re-irradiation
Arm group label:
Partial breast re-irradiation
Summary:
A prospective study of partial breast re-irradiation in patients with local recurrence of
breast cancer
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Isolated ipsilateral unifocal breast lesions;
2. Histologically confirmed invasive breast carcinoma or carcinoma in situ;
3. Limited size (< 2 cm) without evidence of skin involvement;
4. Negative histologic margins of resection;
5. Negative axillary lymph nodes;
6. No synchronous distant metastases;
7. Bilateral breast mammogram or MRI within 120 days prior to study entry;
8. For invasive in-breast recurrence, no more than 120 days since whole-body (positron
emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and
bone scan (if clinically relevant);
9. ≥ 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. 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:
1. Regional recurrences (axillary, supraclavicular);
2. Positive histologic margins at resection;
3. Metastatic disease;
4. Previous breast RT performed with IORT, brachytherapy or previous partial breast
treatment;
5. Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;
6. Patients who had chemotherapy within 2 weeks prior to study RT;
7. Participation in another clinical trial with any investigational agents within 30
days prior to study screening;
8. 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;
9. Significant comorbidity precluding RT 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;
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UO Radioterapia, IRST IRCCS
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Simona Cima
Email:
simona.cima@irst.emr.it
Start date:
March 31, 2023
Completion date:
March 2032
Lead sponsor:
Agency:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Agency class:
Other
Source:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05772390
