anthracycline/cytoxan or taxane chemotherapy planned to be given after surgery) patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes
Patients must have completed all planned neoadjuvant chemotherapy prior to surgery sandwich chemotherapy is not allowed (i.e. equivocal/indeterminate), then patients should not be enrolled * Note: If HER2 status has not been clearly determined (i.e. Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry and/or in situ hybridization ) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy * Note: Biopsy of intramammary nodes does not fulfill eligibility criteria
#Elmhurst abq journal skin
No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervixĪll patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy.Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition.Beginning 3-12 weeks following surgery, patients undergo nodal radiation therapy comprising 3-dimensional (3D) conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), or proton radiation therapy (PRT) 5 days a week for 5-6 weeks.ĪRM II: Patients undergo axillary and nodal radiation therapy comprising 3D-CRT, IMRT, or PRT 5 days a week for 5-6 weeks.Īfter completion of study treatment, patients are followed up at least every 6 months for 2 years and then annually for 3 years. OUTLINE: Patients are randomized to 1 of 2 treatment arms.ĪRM I: Patients undergo axillary lymph node dissection. To estimate the distribution of overall survival. To obtain an estimate of the distribution of residual disease burden scores. To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy. To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive sentinel lymph node(s) (SLN) after completion of neoadjuvant chemotherapy. Why Should I Register and Submit Results?.
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