Trial Comparing 3 Schedules of Hypofractionated Whole Breast Irradiation in Females With Early Stage Breast Cancer

The establishment of conservative breast surgery (CBS) and whole breast irradiation (WBI) as an alternative to mastectomy was a process that occurred over two to three decades. Based on the available evidence, hypofractionated WBI may be safely offered to most women with ductal carcinoma insitu (DCIS) or early-stage invasive breast cancer after CBS. This prospective randomized clinical trial aims to evaluate the outcomes of one-week and once weekly schedules of WBI against the investigator's standard hypofractionated WBI ( 40 Gy /15 fraction /3 weeks) in females with early stage breast cancer after CBS.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Tis, pT1-2, pN0-1, M0 disease
* Invasive carcinoma of the breast or ductal carcinoma insitu \[DCIS\]
* CBS (reconstruction is not allowed)
* Negative surgical margin
* Axillary staging \&/or dissection

Exclusion Criteria:

* pT3-4, pN2-3 breast cancer
* Inadequate axillary lymph node dissection
* Neoadjuvant chemotherapy
* Non-epithelial breast malignancies such as sarcoma or lymphoma
* Synchronous bilateral invasive or non-invasive breast cancer
* History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.)
* Past history of malignancy except
* Basal cell skin cancer
* CIN cervix uteri
* Cosmetic breast implants (Patients who have had implants removed are eligible.)
* Prior breast or thoracic RT for any condition
* Collagen vascular disease, specifically systemic lupus, or scleroderma
* Pregnancy or lactation at the time of radiotherapy. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy

• RESULTBrunt AM, Wheatley D, Yarnold J, Somaiah N, Kelly S, Harnett A, Coles C, Goodman A, Bahl A, Churn M, Zotova R, Sydenham M, Griffin CL, Morden JP, Bliss JM; FAST-Forward Trial Management Group. Acute skin toxicity associated with a 1-week schedule of whole breast radiotherapy compared with a standard 3-week regimen delivered in the UK FAST-Forward Trial. Radiother Oncol. 2016 Jul;120(1):114-8. doi: 10.1016/j.radonc.2016.02.027. Epub 2016 Apr 1. PMID 27046390
• RESULT• Fast forward protocol, Version 3.0: 08/07/2015: https://njl-admin.nihr.ac.uk/document/download/2006786.
• RESULTFAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026. PMID 21752481
• RESULTHaviland 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. PMID 24055415
• RESULTDragun AE, Ajkay NJ, Riley EC, Roberts TL, Pan J, Rai SN, Jain D, Quillo AR, Scoggins CR, McMasters KM, Woo SY. First Results of a Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation (WHBI) for Early-Stage Breast Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):595-602. doi: 10.1016/j.ijrobp.2017.01.212. PMID 28581400