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New treatment option for Breast Cancer
Official title Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation
ClinicalTrials.gov ID: NCT05772390
What this study is testing
- What it's testing
- A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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;
You likely can't join if
- Regional recurrences (axillary, supraclavicular);
- Positive histologic margins at resection;
- Metastatic disease;
- Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;
- Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;
- Patients who had chemotherapy within 2 weeks prior to study RT;
See the full eligibility 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) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan (if clinically relevant);
- ≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence;
- Female, aged \>18 years;
- Life expectancy of greater than 12 months;
- ECOG performance status \<2;
- 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;
- Participant is willing and able to give informed consent for participation in the study;
- Regional recurrences (axillary, supraclavicular);
- Positive histologic margins at resection;
- Metastatic disease;
- Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;
- Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;
- Patients who had chemotherapy within 2 weeks prior to study RT;
- 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...
- Significant comorbidity precluding RT for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus);
- 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...
- Inaccessibility for follow-up;
The study team makes the final eligibility decision.
Where it's taking place
- Meldola, Forlì Cesena, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Meldola, Forlì Cesena, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.