This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy X-rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM 1: Patients are assigned to 1 of 2 treatment groups. GROUP 1A: Lumpectomy patients undergo whole breast radiation therapy using IMRT or 3DCRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks. GROUP 1B: Mastectomy patients do not undergo radiation therapy. ARM 2: Patients are assigned to 1 of 2 treatment groups. GROUP 2A: Lumpectomy patients undergo regional nodal radiation therapy with whole breast radiation therapy using IMRT or 3DCRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks. GROUP 2B: Mastectomy patients undergo regional nodal radiation therapy and chest wall XRT using IMRT or 3DCRT once daily 5 days a week for 5 weeks. All patients also receive systemic therapy as planned (hormonal therapy for patients with hormone-receptor-positive breast cancer and trastuzumab or other anti-human epidermal growth factor receptor 2 [HER2] therapy for patients with breast cancer that is HER2-positive). After completion of study treatment, patients are followed up at 6, 12, 18, and 24 months and then yearly for 8 years.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Definitive clinical or radiologic evidence of metastatic disease
- T4 tumors including inflammatory breast cancer
- Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone
- N2 or N3 disease detected clinically or by imaging
- Patients with histologically positive axillary nodes post neoadjuvant therapy
- Patients with microscopic positive margins after definitive surgery
- Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible)
- Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible)
- History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
- Any radiation therapy for the currently diagnosed breast cancer prior to randomization
- Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
- Prior breast or thoracic radiation therapy (RT) for any condition
- Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma
- Pregnancy or lactation at the time of study entry; (Note: Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)
- Other non-malignant systemic diseases that would preclude the patient from receiving study treatment or would prevent required follow-up
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Kathy Queen, RN