Clinical trial NCT05591547 - References

Breast Cancer — Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen for patIents With Favorable Risk breaSt cancEr

Citation(s)

•   Bonin K, McGuffin M, Presutti R, Harth T, Mesci A, Feldman-Stewart D, Chow E, Di Prospero L, Vesprini D, Rakovitch E, Lee J, Paszat L, Doherty M, Soliman H, Ackerman I, Cao X, Kiss A, Szumacher E
  Breast Cancer Patients' Preferences for Adjuvant Radiotherapy Post Lumpectomy: Whole Breast Irradiation vs. Partial Breast Irradiation-Single Institutional Study. J Cancer Educ. 2018 Feb;33(1):37-43. doi: 10.1007/s13187-016-1016-3.
•   Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG)
  Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. Review.
•   Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists
  Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.
•   Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR
  Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar - Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.
•   Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N
  Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41.
•   Fisher B, Wickerham DL, Deutsch M, Anderson S, Redmond C, Fisher ER
  Breast tumor recurrence following lumpectomy with and without breast irradiation: an overview of recent NSABP findings. Semin Surg Oncol. 1992 May-Jun;8(3):153-60. Review.
•   Grendarova P, Roumeliotis M, Quirk S, Lesiuk M, Craighead P, Liu HW, Pinilla J, Wilson J, Bignell K, Phan T, Olivotto IA
  One-Year Cosmesis and Fibrosis From ACCEL: Accelerated Partial Breast Irradiation (APBI) Using 27 Gy in 5 Daily Fractions. Pract Radiat Oncol. 2019 Sep - Oct;9(5):e457-e464. doi: 10.1016/j.prro.2019.04.002. Epub 2019 Apr 9.
•   Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group
  The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.
•   Hepel JT, Wazer DE
  Update on Partial Breast Irradiation. Clin Breast Cancer. 2021 Apr;21(2):96-102. doi: 10.1016/j.clbc.2020.04.003. Epub 2020 Apr 17. Review.
•   Hoopes DJ, Kaziska D, Chapin P, Weed D, Smith BD, Hale ER, Johnstone PA
  Patient preferences and physician practice patterns regarding breast radiotherapy. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):674-81. doi: 10.1016/j.ijrobp.2010.11.077. Epub 2011 Jan 27.
•   Hughes KS, Schnaper LA, Bellon JR, Cirrincione CT, Berry DA, McCormick B, Muss HB, Smith BL, Hudis CA, Winer EP, Wood WC
  Lumpectomy plus tamoxifen with or without irradiation in women age 70 years or older with early breast cancer: long-term follow-up of CALGB 9343. J Clin Oncol. 2013 Jul 1;31(19):2382-7. doi: 10.1200/JCO.2012.45.2615. Epub 2013 May 20.
•   Jung KYK, Shadbolt B, Rezo A
  Temporal impact of the publication of guidelines and randomised evidence on the adoption of hypofractionated whole breast radiotherapy for early-stage breast cancer. J Med Imaging Radiat Oncol. 2019 Aug;63(4):530-537. doi: 10.1111/1754-9485.12897. Epub 2019 May 14.
•   Kunkler IH, Williams LJ, Jack WJ, Cameron DA, Dixon JM; PRIME II investigators
  Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial. Lancet Oncol. 2015 Mar;16(3):266-73. doi: 10.1016/S1470-2045(14)71221-5. Epub 2015 Jan 28. Erratum in: Lancet Oncol. 2015 Mar;16(3):e105.
•   Lam J, Cook T, Foster S, Poon R, Milross C, Sundaresan P
  Examining Determinants of Radiotherapy Access: Do Cost and Radiotherapy Inconvenience Affect Uptake of Breast-conserving Treatment for Early Breast Cancer? Clin Oncol (R Coll Radiol). 2015 Aug;27(8):465-71. doi: 10.1016/j.clon.2015.04.034. Epub 2015 May 23.
•   Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S
  Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17.
•   Meattini I, Marrazzo L, Saieva C, Desideri I, Scotti V, Simontacchi G, Bonomo P, Greto D, Mangoni M, Scoccianti S, Lucidi S, Paoletti L, Fambrini M, Bernini M, Sanchez L, Orzalesi L, Nori J, Bianchi S, Pallotta S, Livi L
  Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial. J Clin Oncol. 2020 Dec 10;38(35):4175-4183. doi: 10.1200/JCO.20.00650. Epub 2020 Aug 24.
•   Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group
  Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28.
•   Nattinger AB, Kneusel RT, Hoffmann RG, Gilligan MA
  Relationship of distance from a radiotherapy facility and initial breast cancer treatment. J Natl Cancer Inst. 2001 Sep 5;93(17):1344-6.
•   Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA
  Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.
•   Pan IW, Smith BD, Shih YC
  Factors contributing to underuse of radiation among younger women with breast cancer. J Natl Cancer Inst. 2014 Jan;106(1):djt340. doi: 10.1093/jnci/djt340. Epub 2013 Dec 7.
•   Parekh A, Fu W, Hu C, Shen CJ, Alcorn S, Rao AD, Asrari F, Camp MS, Wright JL
  Impact of race, ethnicity, and socioeconomic factors on receipt of radiation after breast conservation surgery: analysis of the national cancer database. Breast Cancer Res Treat. 2018 Nov;172(1):201-208. doi: 10.1007/s10549-018-4881-0. Epub 2018 Aug 6.
•   Pasalic D, Strom EA, Allen PK, Williamson TD, Poenisch F, Amos RA, Woodward WA, Stauder MC, Shaitelman SF, Smith BD, Perkins GH, Tereffe W, Hoffman KE
  Proton Accelerated Partial Breast Irradiation: Clinical Outcomes at a Planned Interim Analysis of a Prospective Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2021 Feb 1;109(2):441-448. doi: 10.1016/j.ijrobp.2020.09.009. Epub 2020 Sep 16.
•   Polgár C, Fodor J, Major T, Sulyok Z, Kásler M
  Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial. Radiother Oncol. 2013 Aug;108(2):197-202. doi: 10.1016/j.radonc.2013.05.008. Epub 2013 Jun 3.
•   Polgár C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgäuer M, Lössl K, Polat B, Kovács G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Pötter R, Gall C, Uter W, Strnad V; Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO)
  Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):259-268. doi: 10.1016/S1470-2045(17)30011-6. Epub 2017 Jan 14.
•   Rippy EE, Ainsworth R, Sathananthan D, Kollias J, Bochner M, Whitfield R
  Influences on decision for mastectomy in patients eligible for breast conserving surgery. Breast. 2014 Jun;23(3):273-8. doi: 10.1016/j.breast.2013.12.009. Epub 2014 Jan 21.
•   Rodríguez N, Sanz X, Dengra J, Foro P, Membrive I, Reig A, Quera J, Fernández-Velilla E, Pera Ó, Lio J, Lozano J, Algara M
  Five-year outcomes, cosmesis, and toxicity with 3-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1051-7. doi: 10.1016/j.ijrobp.2013.08.046. Epub 2013 Oct 22.
•   Smith BD, Bellon JR, Blitzblau R, Freedman G, Haffty B, Hahn C, Halberg F, Hoffman K, Horst K, Moran J, Patton C, Perlmutter J, Warren L, Whelan T, Wright JL, Jagsi R
  Radiation therapy for the whole breast: Executive summary of an American Society for Radiation Oncology (ASTRO) evidence-based guideline. Pract Radiat Oncol. 2018 May - Jun;8(3):145-152. doi: 10.1016/j.prro.2018.01.012. Epub 2018 Mar 12.
•   Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgäuer M, Lössl K, Polat B, Kovács G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Pötter R, Gall C, Malzer M, Uter W, Polgár C; Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO)
  5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.
•   Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N
  Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5.
•   Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B
  Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50.
•   Whelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators
  External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial. Lancet. 2019 Dec 14;394(10215):2165-2172. doi: 10.1016/S0140-6736(19)32515-2. Epub 2019 Dec 5.
•   Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C
  Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.
•   White JR, Winter K, Cecchini RS, Vicini FA, Arthur DW, Kuske RR, Rabinovitch RA, Sehkon A, Khan AJ, Chmura SJ, Shaitelman SF, McCormick B, Julian TB, Rogers CL, Bear HD, Petersen IA, Gustafson GS, Grossheim Jr
  LD, Mamounas E, Ganz PA. Cosmetic outcome from post lumpectomy whole breast irradiation (WBI) versus partial breast irradiation (PBI) on the NRG Oncology/NSABP B39-RTOG 0413 phase III clinical trial. Int J Radiat Oncol. 2019 Sep;105(1):S3-S4.

SH APBI RISE: Evaluating the Safety and Efficacy of a Novel IMRT/VMAT-based Accelerated Partial Breast Irradiation Regimen for patIents With Favorable Risk breaSt cancEr

Details for clinical trial NCT05591547