Breast Neoplasms: Harris JR

Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. · Radiation Oncology Flight, Wilford Hall Medical Center, Lackland AFB, TX, USA. · Int J Radiat Oncol Biol Phys. · Pubmed #19545784 No free full text.

Abstract: PURPOSE: To present guidance for patients and physicians regarding the use of accelerated partial-breast irradiation (APBI), based on current published evidence complemented by expert opinion. METHODS AND MATERIALS: A systematic search of the National Library of Medicine's PubMed database yielded 645 candidate original research articles potentially applicable to APBI. Of these, 4 randomized trials and 38 prospective single-arm studies were identified. A Task Force composed of all authors synthesized the published evidence and, through a series of meetings, reached consensus regarding the recommendations contained herein. RESULTS: The Task Force proposed three patient groups: (1) a "suitable" group, for whom APBI outside of a clinical trial is acceptable, (2) a "cautionary" group, for whom caution and concern should be applied when considering APBI outside of a clinical trial, and (3) an "unsuitable" group, for whom APBI outside of a clinical trial is not generally considered warranted. Patients who choose treatment with APBI should be informed that whole-breast irradiation (WBI) is an established treatment with a much longer track record that has documented long-term effectiveness and safety. CONCLUSION: Accelerated partial-breast irradiation is a new technology that may ultimately demonstrate long-term effectiveness and safety comparable to that of WBI for selected patients with early breast cancer. This consensus statement is intended to provide guidance regarding the use of APBI outside of a clinical trial and to serve as a framework to promote additional clinical investigations into the optimal role of APBI in the treatment of breast cancer.

Morrow M, Strom EA, Bassett LW, Dershaw DD, Fowble B, Giuliano A, Harris JR, O'Malley F, Schnitt SJ, Singletary SE, Winchester DP, Anonymous00163, Anonymous00164, Anonymous00165, Anonymous00166. · Northwestern University Medical School, Chicago, IL, USA. · CA Cancer J Clin. · Pubmed #12363326 links to  free full text

Abstract: Multidisciplinary guidelines for management of invasive breast carcinoma from the American College of Radiology, the American College of Surgeons, the College of American Pathology, and the Society of Surgical Oncology have been updated to reflect the continuing advances in the diagnosis and treatment of invasive breast cancer. The guidelines provide a framework for clinical decision-making for patients with invasive breast carcinoma based on review of relevant literature and include information on patient selection and evaluation, technical aspects of surgical treatment, techniques of irradiation, and follow-up care.

Morrow M, Strom EA, Bassett LW, Dershaw DD, Fowble B, Harris JR, O'Malley F, Schnitt SJ, Singletary SE, Winchester DP, Anonymous00159, Anonymous00160, Anonymous00161, Anonymous00162. · Northwestern University Medical School, Chicago, IL, USA. · CA Cancer J Clin. · Pubmed #12363325 links to  free full text

Abstract: The multidisciplinary guidelines for management of ductal carcinoma in situ of the breast from the American College of Radiology, the American College of Surgeons, the College of American Pathology, and the Society of Surgical Oncology have been updated to take into account continuing advances in the diagnosis and treatment of this disease. The continued growth in mammographic evaluation and technology has resulted in an increase in the diagnosis of ductal carcinoma in situ of the breast (DCIS). The resulting guidelines provide a framework for clinical decision-making for patients with DCIS based on review of relevant literature, and includes information on patient selection and evaluation, technical aspects of surgical treatment, techniques of irradiation, and follow-up care.

Buchholz TA, Haffty BG, Harris JR. · No affiliation provided · J Surg Oncol. · Pubmed #17221862 No free full text.

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Harris JR. · No affiliation provided · J Clin Oncol. · Pubmed #15755963 No free full text.

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Bellon JR, Harris JR. · No affiliation provided · J Clin Oncol. · Pubmed #15545662 No free full text.

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Punglia RS, Harris JR. · No affiliation provided · Ann Surg Oncol. · Pubmed #12095965 No free full text.

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Wong JS, Harris JR. · No affiliation provided · Ann Surg Oncol. · Pubmed #11888866 No free full text.

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Gelman R, Harris JR. · No affiliation provided · Int J Radiat Oncol Biol Phys. · Pubmed #9989509 No free full text.

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Chen RC, Lin NU, Golshan M, Harris JR, Bellon JR. · Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. · J Clin Oncol. · Pubmed #18711171 No free full text.

Abstract: The management of internal mammary nodes (IMNs) in breast cancer is controversial. Surgical series from the 1950s showed that one third of breast cancer patients had IMN involvement, with a higher risk in patients with medial tumors and/or positive axillary nodes. IMN metastasis has similar prognostic importance as axillary nodal involvement. However, after three randomized trials showed no survival benefit from extended mastectomy compared with radical or modified radical mastectomy, IMN dissection was largely abandoned. Recently, lymphoscintigraphy studies have renewed interest in IMN evaluation. Approximately one fifth of internal mammary sentinel nodes are pathologic, although most centers do not perform IMN biopsies because of concerns about morbidity and lack of established survival benefit. In addition, results from randomized trials testing the value of postmastectomy irradiation and a meta-analysis of 78 randomized trials have provided high levels of evidence that local-regional tumor control is associated with long-term survival improvements. This benefit was limited to trials that used systemic therapy, which was not routinely administered in the earlier surgical studies, although the contribution from IMN treatment is unclear. IMN irradiation has also been shown to cause increased cardiac morbidity. Before mature results from current randomized trials assessing the benefit of IMN irradiation become available, lymphoscintigraphy may be used to help guide decisions regarding systemic and local-regional treatment. However, even in patients with visualized primary IMN drainage, the potential benefit of treatment should be balanced against the risk of added morbidity.

Buchholz TA, Lehman CD, Harris JR, Pockaj BA, Khouri N, Hylton NF, Miller MJ, Whelan T, Pierce LJ, Esserman LJ, Newman LA, Smith BL, Bear HD, Mamounas EP. · Department of Radiation Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcolmbe Blvd, Unit 1202, Houston, TX 77030, USA. · J Clin Oncol. · Pubmed #18258988 No free full text.

Abstract: PURPOSE: To review the state of the science with respect to diagnostic imaging and locoregional therapy for patients with breast cancer receiving preoperative chemotherapy. METHODS: Published data relevant to clinical staging, monitoring of tumor response, and locoregional therapy for patients with breast cancer treated with preoperative chemotherapy were reviewed. RESULTS: High-quality data from prospective randomized trials are limited. Available data suggest that locoregional therapy decisions should be based on both the pretreatment clinical extent of disease and the pathologic extent of the disease after chemotherapy. Accordingly, physical examination and imaging studies that accurately define the initial extent of disease are required before treatment. Sentinel lymph node biopsy can be performed either before or after preoperative chemotherapy for patients with clinical N0 disease. The success of breast conservation after preoperative chemotherapy depends on careful patient selection and achieving negative surgical margins. Adjuvant breast radiation is indicated for all patients treated with breast conservation. For patients treated with mastectomy, chest-wall and regional nodal radiation should be considered for those who present with clinical stage III disease or have histologically positive lymph nodes after preoperative chemotherapy. Additional prospective studies are needed to determine the value of postmastectomy radiation for patients with stage II breast cancer who have negative lymph nodes after chemotherapy. CONCLUSION: The increased use of preoperative chemotherapy has raised new questions concerning the optimal methods to stage and monitor disease response to treatment and how to optimize locoregional treatment. The available evidence suggests that a multidisciplinary approach improves outcomes.

Chung CS, Harris JR. · Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. · Breast. · Pubmed #17714945 No free full text.

Abstract: Several randomized trials and the most recent meta-analysis from the Oxford Overview have confirmed the efficacy of post-mastectomy radiation therapy (PMRT) in improving local control and long-term survival. The survival advantage of PMRT has been established in patients with a 10% risk of local regional recurrence. Patients with four or more positive lymph nodes fall in this category, even with effective systemic therapy. However, it remains difficult to identify the subset of patients with 1-3 positive lymph nodes at highest risk of local recurrence, who would most likely demonstrate a survival benefit with PMRT. When PMRT is used, careful treatment planning, particularly with regard to cardiac dose, is critical to minimizing serious late effects of treatment. Further developments in pathologic stratification of these patients, guided by expression profiles or novel biologic markers, are required to enable individualized assessment of long-term therapeutic risks and benefits.

Punglia RS, Morrow M, Winer EP, Harris JR. · Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. · N Engl J Med. · Pubmed #17554121 No free full text.

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Bellon JR, Harris JR. · Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. · Breast. · Pubmed #16236515 No free full text.

Abstract: This review will address: (1) 'what are the current indications for radiation therapy (RT), following both mastectomy and breast-conserving surgery?' and (2) 'if RT is indicated, what are the appropriate volumes or 'targets' to be treated?' Given the complexity of these questions, this review will focus on selected topics considered of greatest current interest. In addition, this review will primarily focus on results obtained from randomized clinical trials (RCTs). Finally, we acknowledge an American point of view in our discussion.

Wong JS, Harris JR. · Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, MA 02115, USA. · Lancet Oncol. · Pubmed #11905613 No free full text.

Abstract: The overall importance of local tumour control in the management of breast cancer, specifically the influence of local control on survival, remains one of the fundamental questions for oncologists. This review addresses the issues surrounding local tumour control, including the evolution of the concept of disease spread, the rationale for local control, the results of studies of radiotherapy after breast-conserving surgery and after mastectomy, and an interpretation of the recent data on post-mastectomy radiotherapy.

Harris JR, Halpin-Murphy P, McNeese M, Mendenhall NP, Morrow M, Robert NJ. · American Society for Therapeutic Radiology & Oncology, Reston, VA 20191, USA. · Int J Radiat Oncol Biol Phys. · Pubmed #10421530 No free full text.

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Winer EP, Harris JR, Smith BL, D'Alessandro HA, Brachtel EF. · Department of Medical Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, USA. · N Engl J Med. · Pubmed #17942877 No free full text.

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Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. · Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. · J Clin Oncol. · Pubmed #16461781 No free full text.

Abstract: PURPOSE: It has been hypothesized that wide excision alone with margins > or = 1 cm may be adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS). To test this hypothesis, we conducted a prospective, single-arm trial. METHODS: Entry criteria included DCIS of predominant grade 1 or 2 with a mammographic extent of < or = 2.5 cm treated with wide excision with final margins of > or = 1 cm or a re-excision without residual DCIS. Tamoxifen was not permitted. The accrual goal was 200 patients. Results: In July 2002, the study closed to accrual at 158 patients because the number of local recurrences met the predetermined stopping rules. The median age was 51 and the median follow-up time was 40 months. Thirteen patients developed local recurrence as the first site of treatment failure 7 to 63 months after study entry. The rate of ipsilateral local recurrence as first site of treatment failure was 2.4% per patient-year, corresponding to a 5-year rate of 12%. Nine patients (69%) experienced recurrence of DCIS and four (31%) experienced recurrence with invasive disease. Twelve recurrences were detected mammographically and one was palpable. Ten were in the same quadrant as the initial DCIS and three were elsewhere within the ipsilateral breast. No patient had positive axillary nodes at recurrence or subsequent metastatic disease. CONCLUSION: Despite margins of > or = 1 cm, the local recurrence rate is substantial when patients with small, grade 1 or 2 DCIS are treated with wide excision alone. This risk should be considered in assessing the possible use of radiation therapy with or without tamoxifen in these patients.

Burstein HJ, Bellon JR, Galper S, Lu HM, Kuter I, Taghian AG, Wong J, Gelman R, Bunnell CA, Parker LM, Garber JE, Winer EP, Harris JR, Powell SN. · Department of Medical Oncology, Dana-Farber Cancer Institute and Brigham & Women's Hospital, and Harvard Medical School, Boston, MA 02115, USA. · Int J Radiat Oncol Biol Phys. · Pubmed #16243442 No free full text.

Abstract: PURPOSE: To evaluate the safety and feasibility of concurrent radiation therapy and paclitaxel-based adjuvant chemotherapy, given either weekly or every 3 weeks, after adjuvant doxorubicin and cyclophosphamide (AC). METHODS AND MATERIALS: After definitive breast surgery and AC chemotherapy, 40 patients with operable Stage II or III breast cancer received protocol-based treatment with concurrent paclitaxel and radiation therapy. Paclitaxel was evaluated on 2 schedules, with treatment given either weeklyx12 weeks (60 mg/m2), or every 3 weeksx4 cycles (135-175 mg/m2). Radiation fields and schedules were determined by the patient's surgery and pathology. The tolerability of concurrent therapy was evaluated in cohorts of 8 patients as a phase I study. RESULTS: Weekly paclitaxel treatment at 60 mg/m2 per week with concurrent radiation led to dose-limiting toxicity in 4 of 16 patients (25%), including 3 who developed pneumonitis (either Grade 2 [1 patient] or Grade 3 [2 patients]) requiring steroids. Efforts to eliminate this toxicity in combination with weekly paclitaxel through treatment scheduling and CT-based radiotherapy simulation were not successful. By contrast, dose-limiting toxicity was not encountered among patients receiving concurrent radiation with paclitaxel given every 3 weeks at 135-175 mg/m2. However, Grade 2 radiation pneumonitis not requiring steroid therapy was seen in 2 of 24 patients (8%) treated in such a fashion. Excessive radiation dermatitis was not observed with either paclitaxel schedule. CONCLUSIONS: Concurrent treatment with weekly paclitaxel and radiation therapy is not feasible after adjuvant AC chemotherapy for early-stage breast cancer. Concurrent treatment using a less frequent paclitaxel dosing schedule may be possible, but caution is warranted in light of the apparent possibility of pulmonary injury.

Bellon JR, Come SE, Gelman RS, Henderson IC, Shulman LN, Silver BJ, Harris JR, Recht A. · Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA. · J Clin Oncol. · Pubmed #15774786 No free full text.

Abstract: PURPOSE: The optimal integration of chemotherapy with radiation (RT) for patients with early-stage breast cancer remains uncertain. We present the long-term results of a prospective randomized trial to address this question. PATIENTS AND METHODS: Two hundred forty-four patients were randomly assigned after conservative breast surgery to receive 12 weeks of cyclophosphamide, doxorubicin, methotrexate, fluorouracil, and prednisone (CAMFP) before RT (CT-first) or after RT (RT-first). Median follow-up for surviving patients was 135 months. RESULTS: There were no significant differences between the CT-first and RT-first arms in time to any event, distant metastasis, or death. Sites of first failure were also not significantly different. CONCLUSION: Among breast cancer patients treated with conservative surgery, there is no advantage to giving RT before adjuvant chemotherapy. However, this study does not have enough statistical power to rule out a clinically important survival benefit for either sequence.

Bellon JR, Shulman LN, Come SE, Li X, Gelman RS, Silver BJ, Harris JR, Recht A. · Department of Radiation Oncology, Brigham and Women's Hospital and the Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts 02115, USA. · Cancer. · Pubmed #15042668 links to  free full text

Abstract: BACKGROUND: Concurrent administration of chemotherapy and radiotherapy has the potential advantage of delaying neither treatment and providing radiation sensitization. However, the optimal approach to concurrent treatment in women with early-stage breast carcinoma remains undefined. We present updated results of a prospective protocol of concurrent cyclophosphamide/methotrexate/5-fluorouracil (CMF) and reduced-dose radiotherapy, focusing on tumor control and patient tolerance. METHODS: One hundred twelve women with AJCC Stage I or Stage II breast carcinoma with 0-3 positive axillary lymph nodes were enrolled in a prospective single-arm study of concurrent CMF and reduced-dose radiotherapy (39.6 gray [Gy] to the whole breast, 16-Gy boost). A high proportion of women had risk factors associated with an increased risk of local disease recurrence, including age <40 (32%), close or positive margins (37%), or lymphatic/vascular invasion (51%). The median follow-up period was 94 months. RESULTS: The 5-year overall survival rate was 94%. By 60 months, 5 patients (4%) experienced local disease recurrence and 19 patients (17%) experienced distant metastasis. There were no isolated regional lymph node recurrences. Local disease recurrence occurred in 1 of 25 patients (4%), 1 of 16 patients (6%), and 3 of 70 patients (4%) with positive, close (<1 mm), and negative margins, respectively. One patient developed acute myelogenous leukemia. An additional patient developed Grade 2 pneumonitis. Cosmetic results were not recorded uniformly for all patients and therefore could not be reliably analyzed. CONCLUSIONS: Concurrent CMF and reduced-dose radiotherapy resulted in a low level of late toxicity and excellent local tumor control, despite the large proportion of patients with substantial risk factors for local disease recurrence. Future studies of concurrent regimens, particularly in patients at high risk of local disease recurrence, are warranted.

Dubey A, Recht A, Come SE, Gelman RS, Silver B, Harris JR, Shulman LN. · Joint Center for Radiation Therapy, Boston, MA, USA. · Int J Radiat Oncol Biol Phys. · Pubmed #10571193 No free full text.

Abstract: PURPOSE: The optimal sequencing of chemotherapy (CT) and radiotherapy (RT) for patients with early-stage breast cancer treated with breast-conserving therapy is unresolved. Given the concerns arising from delaying either CT or RT, we conducted a pilot study of a concurrent CT-RT regimen in the hope that this would reduce side effects without decreasing efficacy. METHODS AND MATERIALS: From 1992-1994, 112 patients with 0-3 positive nodes received 6 monthly cycles of classic oral chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil (5-FU) (CMF). On day 15 of cycle 1, patients started tangential field RT (39.6 Gy in 22 fractions), followed by a 16 Gy boost in 8 fractions. Median follow-up time for surviving patients was 53 months. RESULTS: Moist desquamation developed during or shortly after RT in 50% of patients, but only 5 patients required treatment breaks. Grade 4 neutropenia during RT occurred in 16 patients, but only 1 required hospitalization. One patient developed Grade 2 radiation pneumonitis. Ninety-three percent of patients received at least 85% of prescribed drug doses. Cosmetic scores of 51 evaluable patients approximately 2 years after the end of chemotherapy were 47% excellent, 43% good, and 10% fair. We have observed 4 local failures and 20 distant failures. CONCLUSIONS: This concurrent CT-RT scheme had acceptable toxicity and outcome. Further comparison of this approach allowing prompt initiation of both CT and RT to alternative sequences is warranted.

Hardenbergh PH, Recht A, Gollamudi S, Come SE, Hayes DF, Shulman LN, O'Neill A, Gelman RS, Silver B, Harris JR. · Joint Center for Radiation Therapy, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. · Int J Radiat Oncol Biol Phys. · Pubmed #10477008 No free full text.

Abstract: PURPOSE: There is concern that breast cancer patients treated with left-sided radiation therapy (XRT) and doxorubicin (DOX) may have an increased risk of cardiac toxicity. In addition, the effect of different sequencing of XRT and chemotherapy (CT) on the likelihood of cardiotoxicity, as well as cellulitis, arm edema, or brachial plexopathy, is not well understood. We reviewed the records of patients treated on a randomized trial testing the sequencing of CT and XRT to determine if there was an increase in cardiac events or other complications in patients treated with a total dose of DOX of 180 mg/m2 and XRT, comparing patients with treatment to the left breast and the right breast, and comparing patients treated with initial CT and initial RT. MATERIALS AND METHODS: From June 1984 to December 1992, 244 patients with clinical stage I or II breast cancer were randomized following conservative surgery to receive CT (4 cycles of CAMFP at 3 week intervals) either before or after XRT (45 Gy to the entire breast, followed by a boost of 16 Gy; nodal radiation therapy was optional). Two hundred thirty-one patients were evaluable for the development of cardiac toxicity. The median age at diagnosis was 45 years (range, 20-68). CT doses were: doxorubicin, 45 mg/m2 IV bolus, d 3; methotrexate, 200 mg/m2 IV, d 1 and 15; 5-fluorouracil, 500 mg/m2 IV, d 1; cyclophosphamide, 500 mg/m2 IV, d 1; prednisone 40 mg p.o., d 1-5. A cardiac event was defined as a myocardial infarction or clinical evidence of congestive heart failure. Median follow-up time was 53 months. RESULTS: No cardiac events were observed for patients with either left- or right-sided breast cancer. The sequencing of CT and XRT had no significant effect on the risk of cardiac toxicity, cellulitis, arm edema or brachial plexopathy. CONCLUSIONS: We observed no evidence of an increased risk of cardiac toxicity from the addition of left breast tangential irradiation to DOX at a total dose of 180 mg/m2. Additional follow-up is needed to exclude possible late events. In addition, the sequencing of CT and XRT does not appear to affect the risk of cellulitis, arm edema, or brachial plexopathy.

Nguyen PL, Taghian AG, Katz MS, Niemierko A, Abi Raad RF, Boon WL, Bellon JR, Wong JS, Smith BL, Harris JR. · Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA, USA. · J Clin Oncol. · Pubmed #18413639 No free full text.

Abstract: PURPOSE: To determine whether breast cancer subtype is associated with outcome after breast-conserving therapy (BCT) consisting of lumpectomy and radiation therapy. PATIENTS AND METHODS: We studied 793 consecutive patients with invasive breast cancer who received BCT from July 1998 to December 2001. Among them, 97% had pathologically negative margins of resection, and 90% received adjuvant systemic therapy. No patient received adjuvant trastuzumab. Receptor status was used to approximate subtype: estrogen receptor (ER) or progesterone receptor (PR) positive and human epidermal growth factor receptor 2 negative = luminal A; ER+ or PR+ and HER-2+ = luminal B; ER-and PR -and HER-2+ = HER-2; and ER-and PR -and HER-2-= basal. Competing risks methodology was used to analyze time to local recurrence and distant metastases. RESULTS: Median follow-up was 70 months. The overall 5-year cumulative incidence of local recurrence was 1.8% (95% CI, 1.0 to 3.1); 0.8% (0.3, 2.2) for luminal A, 1.5% (0.2, 10) for luminal B, 8.4% (2.2, 30) for HER-2, and 7.1% (3.0, 16) for basal. On multivariable analysis (MVA) with luminal A as baseline, HER-2 (adjusted hazard ratio [AHR] = 9.2; 95% CI, 1.6 to 51; P = .012) and basal (AHR = 7.1; 95% CI, 1.6 to 31; P = .009) subtypes were associated with increased local recurrence. On MVA, luminal B (AHR = 2.9; 95% CI, 1.3 to 6.5; P = .007) and basal (AHR = 2.3; 95% CI, 1.1 to 5.2; P = .035) were associated with increased distant metastases. CONCLUSION: Overall, the 5-year local recurrence rate after BCT was low, but varied by subtype as approximated using ER, PR, and HER-2 status. Local recurrence was particularly low for the luminal A subtype, but was less than 10% at 5 years for all subtypes. Although further follow-up is needed, these results may be useful in counseling patients about their anticipated outcome after BCT.

Wong JS, Taghian AG, Bellon JR, Keshaviah A, Smith BL, Winer EP, Silver B, Harris JR. · Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA. · Int J Radiat Oncol Biol Phys. · Pubmed #18394815 No free full text.

Abstract: PURPOSE: To determine the risk of regional-nodal recurrence in patients with early-stage, invasive breast cancer, with clinically negative axillary nodes, who were treated with breast-conserving surgery, "high tangential" breast radiotherapy, and hormonal therapy, without axillary surgery or the use of a separate nodal radiation field. METHODS AND MATERIALS: Between September 1998 and November 2003, 74 patients who were >/=55 years of age with Stage I-II clinically node-negative, hormone-receptor-positive breast cancer underwent tumor excision to negative margins without axillary surgery as a part of a multi-institutional prospective study. Postoperatively, all underwent high-tangential, whole-breast radiotherapy with a boost to the tumor bed, followed by 5 years of hormonal therapy. RESULTS: For the 74 patients enrolled, the median age was 74.5 years, and the median pathologic tumor size was 1.2 cm. Lymphatic vessel invasion was present in 5 patients (7%). At a median follow-up of 52 months, no regional-nodal failures or ipsilateral breast recurrences had been identified (95% confidence interval, 0-4%). Eight patients died, one of metastatic disease and seven of other causes. CONCLUSION: In this select group of mainly older patients with early-stage hormone-responsive breast cancer and clinically negative axillary nodes, treatment with high-tangential breast radiotherapy and hormonal therapy, without axillary surgery, yielded a low regional recurrence rate. Such patients might be spared more extensive axillary treatment (axillary surgery, including sentinel node biopsy, or a separate nodal radiation field), with its associated time, expense, and morbidity.