A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000021016
- Lead Sponsor
- RG Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 1636
Not provided
1) Definitive clinical or radiologic evidence of metastatic disease. 2) T4 tumors including inflammatory breast cancer. 3) Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone. 4) N2 or N3 disease detected clinically or by imaging. 5 Histologically positive axillary nodes post neoadjuvant therapy. 6)Microscopic positive margins after definitive surgery. 7) Synchronous or previous contralateral invasive breast cancer or DCIS. 8) Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy 9) History of non-breast malignancies within 5 years prior to randomization. 10) Any radiation therapy for the currently diagnosed breast cancer prior to randomization. 11) Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy. 12) Prior breast or thoracic RT for any condition. 13) Active collagen vascular disease,specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. 14) Pregnancy or lactation at the time of study entry 15) Other non-malignant systemic disease that would preclude the patientfrom receiving study treatment or would prevent required follow-up. 16)Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the studyrequirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method