3-dimensional conformal radiation therapy or internal radiation therapy after breast-conserving surgery in treating women with stage i or stage ii breast cancer

Conditions: Breast Cancer

Summary: rationale: specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. giving these treatments after surgery may kill any tumor cells that remain after surgery. it is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer. purpose: this randomized phase ii trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage i or stage ii breast cancer.

objectives: primary * to compare the rate of successfully delivered accelerated partial breast irradiation (apbi) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brachytherapy in women with stage i or ii invasive ductal carcinoma of the breast. * to establish potential patient participation in ongoing phase iii clinical trials (e.g., nsabp-b-39, gec-estro, rapid, mport, and irma) that compare apbi to standard whole-breast irradiation. secondary * to assess acute radiation-induced toxicity in these patients as assessed by nci ctcae version 3.0. * to assess long-term radiation-induced toxicity in these patients as assessed by rtog-eortc scale. * to assess the incidence and type of adverse events in the breast of these patients. * to assess the incidence and type of procedure-related complications in these patients. * to determine local control and pattern of recurrence in these patients. * to determine disease-free survival (distant and recurrence-free survival) of these patients. * to determine overall survival of these patients. * to assess cosmesis in these patients as assessed by the breast cancer treatment outcome and rtog scales. * to assess treatment-related symptoms in these patients as assessed by the breast cancer treatment outcome scale. outline: patients are randomized to 1 of 2 treatment arms. patients with a lumpectomy cavity/whole breast ratio 25-30% are assigned to treatment in arm ii. * arm i: patients undergo accelerated partial breast irradiation (apbi) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. * arm ii: patients undergo apbi using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. patients complete quality-of-life questionnaires at baseline, on the last day of treatment, at 4 and 24 weeks after completion of treatment, and then annually for 3 years. after completion of study treatment, patients are followed periodically for at least 5 years.

Eligibility criteria:
disease characteristics: * pathologically proven invasive ductal carcinoma of the breast * stage i or ii disease (pathological tumor size ≤ 3 cm, n0, m0 disease) * no t2 (tumor size \> 3 cm) or t3 disease * no lymph node (l0) or hemangiosis (v0) invasion * unilateral, unifocal, and unicentric tumor without associated suspicious diffuse microcalcification in the ipsilateral or contralateral breast * no multifocal/multicentric disease * previously treated with breast-conserving surgery with adequate axillary node management * negative surgical resection margins for tumor (invasive tumor or ductal carcinoma in situ \[dcis\]) on histology * clearly identified primary tumor excision cavity (clips recommended) with a target lumpectomy cavity/whole breast ratio quantifiable and ≤ 25% on the post-operative ct scan * patients with a lumpectomy cavity/whole breast ratio 25-30% are eligible but will undergo partial breast irradiation using multi-catheter interstitial brachytherapy during study * breast size amenable to partial breast irradiation (i.e., \> a-cup size) * no other pathological invasive tumor or dcis * no associated extensive dcis component (\< 25%) * no associated paget's disease of the nipple * hormone receptor status not specified patient characteristics: * menopausal status not specified * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no breast implants * no collagen vascular disease * no psychiatric condition or other condition that, in the opinion of the investigator, would preclude study requirements prior concurrent therapy: * see disease characteristics * no prior radiotherapy * no concurrent chemotherapy * sequential chemotherapy allowed * concurrent hormonal therapy allowed

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer invasive ductal breast carcinoma