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Compares treatment options for Local Neoplasm Recurrence
Official title Partial Breast Versus no Irradiation for Women With Early Breast Cancer
ClinicalTrials.gov ID: NCT03646955
What this study is testing
- What it's testing
- All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, women only
You may be able to join if
- Female patient \>=60 years Primary tumour characteristics by conventional histopathology
- unilateral and unifocal non-lobular histology grade 1-2
- maximum microscopic size \<=20mm
- node negative determined by sentinel node or axillary lymph node dissection
- estrogen receptor \>=10% positive
You likely can't join if
- multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
- evidence of clinical or pathological T4 breast cancer
- grade 3 malignancy
- previous breast cancer or DCIS irrespective of disease-free interval
- previous radiation therapy to the breast or thorax,
- previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.
See the full eligibility criteria
- Female patient \>=60 years Primary tumour characteristics by conventional histopathology
- unilateral and unifocal non-lobular histology grade 1-2
- maximum microscopic size \<=20mm
- node negative determined by sentinel node or axillary lymph node dissection
- estrogen receptor \>=10% positive
- HER2 negative (by IHC and/or in situ hybridization)
- resection margin \>=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer Surgical type is breast conservation Performance status ECOG 0-2 No evidence of distant metastasis
- multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
- evidence of clinical or pathological T4 breast cancer
- grade 3 malignancy
- previous breast cancer or DCIS irrespective of disease-free interval
- previous radiation therapy to the breast or thorax,
- previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.
- comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
- mental/psychiatric disorder which precludes the patient from understanding the randomization and the follow up.
- documented hereditary breast cancer or with high genetic risk of breast cancer
- life expectancy \<10 years
The study team makes the final eligibility decision.
Where it's taking place
- Santiago, Chile
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Herlev, Denmark
- Næstved, Denmark
- Odense, Denmark
- Vejle, Denmark
- Bergen, Norway
- Bodø, Norway
- Kristiansand, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Gothenburg, Sweden
- Lund, Sweden
- Uppsala, Sweden
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, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago, Chile; Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Herlev, Denmark; Næstved, Denmark and 11 more location(s). 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.