Weischenfeldt KLH, Kirkegaard T, Rasmussen BB, Giobbie-Hurder A, Jensen M, Ejlertsen B, Lykkesfeldt AE. A high level of estrogen-stimulated proteins selects breast cancer patients treated with adjuvant endocrine therapy with good prognosis. E-published Acta Oncol, 10 May 2017 (BIG-198).
Bartlett JMS, Ahmed I, Regan MM, Sestak I, Mallon EA, Dell'Orto P, Thürlimann B, Seynaeve C, Putter H, Van de Velde CJH, Brookes CL, Forbes JF, Viale G, Cuzick J, Dowsett M, Rea DW; Trans-AIOG. HER2 status predicts for upfront AI benefits: A TRANS-AIOG meta-analysis of 12129 patients from ATAC, BIG 1-98 and TEAM with centrally determined HER2. E-published Eur J Cancer, 9 May 2017 (BIG 1-98).
Morden JP, Alvarez I, Bertelli G, Coates AS, Coleman R, Fallowfield L, Jassem J, Jones S, Kilburn L, Lønning PE, Ortmann O, Snowdon C, van de Velde C, Andersen J, Del Mastro L, Dodwell D, Holmberg S, Nicholas H, Paridaens R, Bliss JM, Coombes RC. Long-Term Follow-Up of the Intergroup Exemestane Study. E-published J Clin Oncol, 3 May 2017 (IBCSG 16-98).
363. Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, Gómez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer Jr. CE, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio‑Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM, the SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med. doi: 10.1056/NEJMoa1803164. 2018 June 4. [Epub ahead of print] (IBCSG 24-02, 25-02) (Journal Impact Factor 72.406).
Drs. Francis and Pagani, et al reported the updated results of IBCSG-led Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT). Premenopausal women were randomly assigned to receive 5 years of adjuvant tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression in SOFT; or to receive 5 years of adjuvant tamoxifen plus ovarian suppression or exemestane plus ovarian suppression in TEXT. Among premenopausal women with early breast cancer, the addition of ovarian suppression to tamoxifen resulted in significantly improved disease-free and overall survival compared with tamoxifen alone. The use of exemestane plus ovarian suppression further reduced recurrence as compared with both tamoxifen alone and tamoxifen plus ovarian suppression.
The paper is attached and linked here: https://www.nejm.org/doi/full/10.1056/NEJMoa1803164.
Dr. Marc Lippman’s editorial is attached and linked here: https://www.nejm.org/doi/full/10.1056/NEJMe1806130?query=recirc_curatedRelated_article.
362. Zeidan YH, Habib JG, Ameye L, Paesmans M, de Azambuja E, Gelber RD, Campbell I, Nordenskjöld B, Gutiérez J, Anderson M, Lluch A, Gnant M, Goldhirsch A, Di Leo A, Joseph DJ, Crown J, Piccart-Gebhart M, Francis PA. Postmastectomy radiation therapy in women with T1-T2 tumors and 1 to 3 positive lymph nodes: Analysis of the Breast International Group 02-98 Trial. Int J Radiat Oncol Biol Phys 2018 Jun 1:101(2):316-324. doi: 10.1016/j.ijrobp.2018.01.105. Epub 2018 February 6. (IBCSG 20-98) (Journal Impact Factor 5.133).
361. Dowsett M, Sestak I, Regan MM, Dodson A, Viale G, Thürlmann B, Colleoni M, Cuzick J. Integration of clinical variables for the prediction of late distant recurrence in patients with oestrogen receptor positive breast cancer treated with 5 years of endocrine therapy: CTS5. J Clin Oncol. doi: 10.1200/JCO.2017.76.4258. 2018 April 20. [Epub ahead of print] (BIG 1-98) (Journal Impact Factor 24.08).
Professor Dowsett et al developed and validated a simple clinicopathologic tool (Clinical Treatment Score post–5 years [CTS5]) to estimate residual risk of distant recurrence after 5 years of endocrine treatment. The ATAC data set (N = 4,735) was used to create a prognostic score for post–5-year risk of late distant recurrence, and validity of CTS5 (ATAC) was validated in the BIG 1-98 data set (N = 6,711). Results were published in the Journal of Clinical Oncology.
The paper and data supplement are attached and linked here: http://ascopubs.org/doi/full/10.1200/JCO.2017.76.4258
360. Munzone E, Gray KP, Fumagalli C, Guerini-Rocco E, Láng I, Ruhstaller T, Gianni L, Kammler R, Viale G, Di Leo A, Coates AS, Gelber RD, Regan MM, Goldhirsch A, Barberis M, Colleoni M. Mutational analysis of triple-negative breast cancers within the International Breast Cancer Study Group (IBCSG) Trial 22-00. Breast Cancer Res Treat. doi: 10.1007/s10549-018-4767-1. Epud 2018 March 27. [Epub ahead of print] (IBCSG 22-00).
Dr. Munzone et al investigated the occurrence and the prognostic and predictive relationship of a selected number of somatic mutations in triple-negative breast cancer (TNBC) patients having known clinical outcomes treated within the IBCSG Trial 22-00. Mutational analysis was performed with OncoCarta panel v1.0 using Mass Array System. The panel includes 19 genes belonging to different functional pathways as PI3K pathway, receptor tyrosine kinase and cell cycle-metabolic group. Mutation assessment was successful for 135 patients (49 cases, 86 controls). A manuscript was published in Breast Cancer Research Treatment.
The paper and is attached and linked here:
359. Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martin M, Nortier JWR, Paterson AHG, Rimawi MF, Lang I, Baena-Cañada JM, Thürlimann B, Mamounas EP, Geyer Jr CE, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S, International Breast Cancer Study Group, NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists’ Group, Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. doi: 10.1200/JCO.2017.76.5719. Epub 2018 February 14. [Epub ahead of print] (IBCSG 27-02).
The CALOR trial investigates the effectiveness of chemotherapy (CT) following local therapy for isolated locoregional recurrence (ILRR), which is associated with a high risk of developing breast cancer distant metastases and death. From August 2003 to January 2010, 162 patients were enrolled. Eligible patients were randomized to CT or No-CT, and stratified by prior CT, hormone-receptor (ER, PR) status, and location of ILRR. A report after 5 years median follow-up showed significant benefit of CT for ER-negative ILRR, but further follow-up was required in ER-positive ILRR.
The final analysis of CALOR after 9 years median follow-up confirms that CT benefits patients with resected ER-negative ILRR. Long-term CALOR trial results do not support the use of CT for ER+ ILRR. The final analysis of the trial was displayed during a poster session at ASCO 2017 and a manuscript has now been published in the Journal of Clinical Oncology.
The paper is attached and linked here:
The editorial is attached and linked here:
358. Lee CK, Hudson M, Simes J, Ribi K, Bernhard J, Coates AS. When do patient reported quality of life indicators become prognostic in breast cancer? Health Qual Life Outcomes. 2-18(16)13. doi: 10.1186/s12955-017-0834-2. Epub 2018 January 12. (IBCSG VI–IX and 13–15) (Impact Factor 2.143).
Dr. Lee’s manuscript investigates individual patient data meta-analysis of seven IBCSG Trials (VI–IX and 13–15) investigated the prognostic value of QL scores at several times before and after disease relapse on overall survival. Among 8024 patients enrolled in one of seven randomized controlled trials in early-stage breast cancer, 3247 had a breast cancer relapse after a median follow-up of 12.1 years. Of these, 677 had completed QL indicator assessments within defined windows 1, 2 or 3 months prior to relapse. Cox regression analyses were performed using these assessments and using identical instruments after relapse. Results have been published in Health and Quality of Life Outcomes.
The paper is attached and linked here:
357. Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, Peto R, Pritchard KI, Bergh J, Dowsett M, Hayes DF; EBCTCG. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med 2017 Nov 9;377(19):1836-1846. doi: 10.1056/NEJMoa1701830. (Journal Impact Factor 72.406).
356. Wang XV, Cole B, Bonetti M, Gelber RD. Meta-STEPP with Random Effects. Res Synth Methods. doi: 10.1002/jrsm.1288. Epub 2017 December 27. [Epub ahead of print] (Journal Impact Factor 3.018).
355. Alkner S, Jensen MB, Rasmussen BB, Bendahl PO, Fernö M, Rydén L, Mouridsen H, and Danish Breast Cancer Cooperative Group. Prognostic and predictive importance of the estrogen receptor coactivator AIB1 in a randomized trial comparing adjuvant letrozole and tamoxifen therapy in postmenopausal breast cancer: the Danish cohort of BIG 1-98. Breast Cancer Res Treat 2017;166(2):481-490. doi: 10.1007/s10549-017-4416-0. Epub 2017 August 1.
Alkner’s paper and is attached and linked here:
354. Lykkesfeldt AE, Iversen BR, Jensen MB, Ejlertsen B, Giobbie-Hurder A, Reiter BE, Kirkegaard T, Rasmussen BB. Aurora kinase A as a possible marker for endocrine resistance in early estrogen receptor positive breast cancer. Acta Oncol 2018;57(1):67-73. doi: 10.1080/0284186X.2017.1404126. Epub 2017 December 4.
Lykkesfeldt’s paper and is attached and linked here: http://www.tandfonline.com/doi/abs/10.1080/0284186X.2017.1404126?journalCode=ionc20.
353. Procter M, Robertson C. Imputing missing quality of life data as covariate in survival analysis of the International Breast Cancer Study Group Trials VI and VII. Communications in Statistics – Simulation and Computation. doi: 10.1080/03610918.2017.1390123. Epub 2017 December 15. [Epub ahead of print] (IBCSG VI, VII) (Journal Impact Factor 0.457).
352. Gennari A, Sun Z, Hasler-Strub U, Colleoni M, Kennedy MJ, Von Moos R, Cortés J, Vidal MJ, Hennessy B, Walshe J, Amillano Parraga K, Ribi K, Bernhard J, Morales SM, Pagani O, Barbeaux A, Borstnar S, Rabaglio-Poretti M, Maibach R, Regan MM, Jerusalem G. A randomized phase II study evaluating different maintenance schedules of nab-Paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial. Ann Oncol. doi: 10.1093/annonc/mdx772. Epub 2017 December 8. [Epub ahead of print] (IBCSG 42-12) (Journal Impact Factor 11.855).
351. Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Hitre E, Graas MP, Simoncini E, Kamby C, Thompson A, Loibl S, Gavilá J, Kuroi K, Marth C, Müller B, O’Reilly S, Di Lauro V, Gombos A, Ruhstaller T, Burstein H, Ribi K, Bernhard J, Viale G, Maibach R, Rabaglio-Poretti M, Gelber RD, Coates AS, Di Leo A, Regan MM, Goldhirsch A; SOLE Investigators. Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. doi: 10.1016/S1470-2045(17)30715-5. 2017 Nov 17. [Epub ahead of print] (IBCSG 35-07).
The SOLE trial is a randomized phase III clinical trial that enrolled almost 4,900 postmenopausal women, in 22 countries, with hormone-sensitive, lymph node-positive breast cancer who were breast cancer-free following 4 to 6 years of prior adjuvant endocrine therapy. Patients were randomly assigned to extend endocrine therapy by either taking an additional 5 years of continuous letrozole or 5 years of intermittent letrozole; taken for the first 9 months during years 1 to 4, and then continuously for 12 months in year 5). This is the first trial that evaluates a de-escalation of extended adjuvant endocrine therapy. 5 years of intermittent letrozole did not reduce the risk of recurrence of breast cancer compared with taking the aromatase inhibitor treatment continuously for 5 years. The results were presented at the 2017 ASCO Annual Meeting and published online in The Lancet Oncology.
The paper and supplement are attached and linked here: http://dx.doi.org/10.1016/S1470-2045(17)30715-5 .
The editorial is attached and linked here:
The commentary is attached and linked here: https://jamanetwork.com/journals/jamaoncology/article-abstract/2663286.
350. von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med 2017;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5 (IBCSG 39-11) (Journal Impact Factor 72.406).
The APHINITY trial randomzed 4,805 patients, 278 from IBCSG, to chemotherapy plus one year of trastuzumab plus placebo or to chemotherapy plus one year of trastuzumab plus pertuzumab, aiming to determine whether the addition of pertuzumab improves invasive disease-free survival (IDFS) in patients with HER2-positive early breast cancer. The patients assigned pertuzumab had significantly improved rates of IDFS, when compared to the patients assigned placebo (3-year rates of iDFS were 94.1% in the pertuzumab group and 93.2% in the placebo group). The results were presented at the 2017 ASCO Annual Meeting and concurrently published in the New England Journal of Medicine.
349. Willis S, Sun Y, Abramovitz M, Fei T, Young B, Lin X, Ni M, Achua J, Regan MM, Gray KG, Gray R, Wang V, Long B, Kammler R, Sparano JA, Williams C, Goldstein LJ, Salgado R, Loi S, Pruneri G, Viale G, Brown M, Leyland-Jones B. High expression of FGD3, a putative regulator of cell morphology and motility, is prognostic of favorable outcome in multiple cancers. J Clin Oncol Precis Oncol. doi: 10.1200/PO.17.00009. 2017 October 13. [Epub ahead of print] (BIG 1-98).
Exploratory analysis of 20,464 possible single-gene biomarkers in METABRIC discovery cohort and a confirmatory meta-analysis of ER-positive and ER-negative breast cancer cohorts confirmed better overall survival with high expression of FGD3 mRNA. In BIG 1-98, FGD3 mRNA was associated with freedom from recurrence. FGD3 was previously shown to inhibit cell migration and is regulated by ESR1. FGD3 may be an important clinical biomarker.
348. Ribi K, Coates AS, Blacher L, Regan MM, Gelber RD, Bernhard J. Assessing health-related quality of life in patients with breast cancer: a reply to Maratia et al. Qual Life Res. doi: 10.1007/s11136-017-1695-1. 2017 September 5 [Epub ahead of print] (Commentary).
lt these characteristics were misrepresented and sometimes incorrect, and critical research of the Form’s development was overlooked in the Rating.
347. Regan MM, Walley BA, Francis PA, Fleming GF, Láng I, Gómez HL, Colleoni M, Tondini C, Pinotti G, Salim M, Spazzapan S, Parmar V, Ruhstaller T, Abdi EA, Gelber RD, Coates AS, Goldhirsch A, Pagani O. Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT. Ann Oncol 0: 1-8, 2017. First published online July 29, 2017 (IBCSG 24-02 and 25-02) (Journal Impact Factor 11.855).
The phase III SOFT and TEXT trials differed by initiating OFS sequentially to and concurrently with chemotherapy, respectively, if chemotherapy was given to premenopausal patients with HR+ breast cancer. . This paper investigates the potential benefits of concurrent vs. sequential OFS initiation with chemotherapy among 1872 patients enrolled in SOFT and TEXT who initiated OFS with the GnRH agonist triptorelin.
346. Curigliano G, Burstein HJ, Winer EP, Gnant M, Dubsky P, Loibl S, Colleoni M, Regan MM, Piccart-Gebhart M, Senn HJ, Thürlimann B. De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol 28: 1700–1712, 2017. First published online June 21, 2017. (Commentary) (Journal impact factor 11.855).
This paper summarizes the current status of primary therapy of early breast cancer based on the 2017 St. Gallen International Expert Consensus Conference. Supplementary material includes the questions and results from the consensus meeting.
345. Francis PA. Adjuvant endocrine therapy for premenopausal women: Type and duration. E-published Breast 2017 June 29.
In this commentary, Dr. Prue Francis, SOFT Study Co-Chair, reviews trials and meta-analyses of treatments for hormone-responsive early breast cancer, with emphasis on postmenopausal subgroup. In particular, the paper recommends that very young women under age 35 with ER-positive breast cancer have higher risks of recurrence, and the use of ovarian suppression with oral endocrine therapy should be considered.
344. Saha P, Regan MM, Pagani O, Francis PA, Walley BA, Ribi K, Bernhard J, Luo W, Gómez HL, Burstein HJ, Parmar V, Torres R, Stewart J, Bellet M, Perelló A, Dane F, Moreira A, Vorobiof D, Nottage M, Price KN, Coates AS, Goldhirsch A, Gelber RD, Colleoni M, Fleming GF; SOFT; TEXT Investigators; International Breast Cancer Study Group. Treatment efficacy, adherence, and quality of life among women younger than 35 years in the International Breast Cancer Study Group TEXT and SOFT adjuvant endocrine therapy trials. E-published J Clin Oncol 2017 June 27 (IBCSG 24-02 and 25-02).
This article describes the treatment efficacy, quality of life, and treatment adherence of women younger than 35 years old in the SOFT and TEXT trials. Between the TEXT and SOFT trials, more than 5,700 patients were enrolled from November 2003 until March 2011; roughly 600 patients were younger than 35 years old and form the basis of the analysis.
343. Weischenfeldt KLH, Kirkegaard T, Rasmussen BB, Giobbie-Hurder A, Jensen M, Ejlertsen B, Lykkesfeldt AE. A high level of estrogen-stimulated proteins selects breast cancer patients treated with adjuvant endocrine therapy with good prognosis. E-published Acta Oncol 2017 May 10 (BIG 1-98).
This investigation was based on archival tumor tissue from 1323 Danish breast cancer patients enrolled in BIG 1-98. The aim was to determine if patients with high levels of expression for the estrogen receptor (ER), progesterone receptor, BCL-2, and IGF-IR, had improved prognosis following adjuvant endocrine therapy. Patients were classified into ER activity groups based on the levels of these biomarkers. The investigation showed that patients with the highest ER activity profile had significantly longer DFS and OS. The authors recommend additional investigations to assess whether the ER activity profile can be used to identify ER-positive, high-risk breast cancer patients who can be spared adjuvant chemotherapy.
342. Morden JP, Alvarez I, Bertelli G, Coates AS, Coleman R, Fallowfield L, Jassem J, Jones S, Kilburn L, Lønning PE, Ortmann O, Snowdon C, van de Velde C, Andersen J, Del Mastro L, Dodwell D, Holmberg S, Nicholas H, Paridaens R, Bliss JM, Coombes RC. Long-term follow-up of the intergroup exemestane study. E-published J Clin Oncol 2017 May 3 (IBCSG 16-98).
This final report of the Intergroup Exemestane Study (IES) presents results after median follow-up of 10 years. Among patients with ER-positive or ER-unknown tumors, the authors reported a modest improvement in overall survival with switching to exemestane vs continuing tamoxifen, after 2-3 years of tamoxifen. The IES and other studies have established the value of a strategy of switching to an AI after 2 to 3 years of tamoxifen to reduce disease recurrence and breast cancer mortality.
341. Bartlett JMS, Ahmed I, Regan MM, Sestak I, Mallon EA, Dell'Orto P, Thürlimann B, Seynaeve C, Putter H, Van de Velde CJH, Brookes CL, Forbes JF, Viale G, Cuzick J, Dowsett M, Rea DW; Trans-AIOG. HER2 status predicts for upfront AI benefits: A TRANS-AIOG meta-analysis of 12129 patients from ATAC, BIG 1-98 and TEAM with centrally determined HER2. Euro J Cancer 79:129-138, 2017 (BIG 1-98) (Journal impact factor 6.029).
This is the first investigation of the translational working group of the AI Overview Group (Trans-AIOG), combining individual patient data from 3 of the randomized trials of AI vs tamoxifen that had centrally-assessed HER2 status, to investigate the predictive value of HER2 status for selection of upfront AI vs. tamoxifen in the first 2-3 years of treatment. 6182 of 8010 BIG 1-98 patients contributed to the analysis. The investigation found a statistically significant HER2-by-treatment interaction, suggesting greater benefit of AI for HER2-negative tumors than for HER2-positive tumors. Yet there was heterogeneity of results between trials, in particular for the smaller group of HER2-positive tumors, and few of these patients received HER2-targeted therapy. Thus the results indicate further research is needed.
340. Borgquist S, Giobbie-Hurder A, Ahern TP, Garber JE, Colleoni M, Láng I, Debled M, Ejlertsen B, von Moos R, Smith I, Coates AS, Goldhirsch A, Rabaglio M, Price KN, Gelber RD, Regan MM, Thürlimann B. Cholesterol, Cholesterol-Lowering Medication Use, and Breast Cancer Outcome in the BIG 1-98 Study. J Clin Oncol. 35:1179-1188, 2017 (IBCSG 18-98) (Journal impact factor 20.982).
In this analysis of the BIG 1-98 trial, patients in the 4-arm cohort (N=6,182) were evaluated to determine the role of cholesterol lowering medications (CLM) in preventing breast cancer recurrences. The analysis relies on the systemic levels of total cholesterol and use of CLMs which were collected at baseline and every six months up to 5.5 years during trial treatment.
339. Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, Castro G Jr, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, McFadden E, Leyland-Jones B, Bell R, Dowsett M, Jackisch C; Herceptin Adjuvant (HERA) Trial Study Team. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet 389:1195-1205, 2017 (IBCSG 28-02) (Journal impact factor 44.002).
The final analysis of the HERA trial has been published in Lancet. The HERA trial (IBCSG 28-02) randomized 5,102 women with HER2-positive early breast cancer. As noted in the paper, “(t)o our knowledge, this 11-year follow-up of the HERA trial provides the longest survival data of any trial that assessed the addition of anti-HER2 therapy to standard treatment for HER2-positive early breast cancer.”
338. Wapnir IL, Gelber S, Anderson SJ, Mamounas EP, Robidoux A, Martín M, Nortier JW, Geyer CE Jr, Paterson AH, Láng I, Price KN, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; CALOR trial investigators. Poor prognosis after second locoregional recurrences in the CALOR trial. Ann Surg Oncol 24:398-406, 2017 (IBCSG 27-02) (Journal impact factor 3.151).
The first IBCSG paper of 2017, published in the Annals of Surgical Oncology, was based on the primary database from the CALOR trial. A total of 162 patients who had an isolated locoregional recurrence (ILRR) after primary therapy were randomly assigned to receive chemotherapy or no chemotherapy after resection of ILRR. This research project evaluated second ILRRs, management practices for dealing with ILRR, and hormone receptor status. Second ILRRs represented about one third of all recurrence events after the first ILRR, and all were PR-negative.