Partial Breast Versus no Irradiation for Women With Early Breast Cancer

Launched by DANISH BREAST CANCER COOPERATIVE GROUP · Aug 23, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring whether some women with early breast cancer can safely skip radiation therapy after surgery. Typically, radiation is recommended after breast-conserving surgery to reduce the chance of cancer returning, but not all patients benefit from it. This study aims to identify specific characteristics that could help doctors determine which patients are at low risk for cancer returning and may not need radiation, thus avoiding potential side effects.

To participate, women must be at least 60 years old and have certain types of breast cancer, such as a single tumor that is smaller than 20 mm and has specific low-grade features. They should have no cancer spread to the lymph nodes and meet other health criteria. If eligible, participants will be monitored closely to see how they do without radiation. It’s an important trial that may help tailor treatment for breast cancer patients in the future, reducing unnecessary treatments for those who are unlikely to benefit from them.

Gender

FEMALE

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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