Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery

NCT04669873 | Recruiting

• 1 other identifier: 38341220.8.0000.0072
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer. There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.

Conditions

Malignant Neoplasm of Breast

Keywords

Breast Cancer; Radiotherapy; Hypofractionated; Breast-conserving surgery

Outcome Measures

Primary Outcomes (1)

• Rate of local recurrence

  To estimate and compare the rate of local recurrence between the experimental and control arms.

  5 years

Secondary Outcomes (12)

• Time to occurrence of distant metastases

  5 years

• Disease-free survival

  5 years

• Overall survival

  5 years

• Medico-economic study

  Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

• Health-related Quality of Life

  Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

Study Arms (3)

Active Comparator: Standard

ACTIVE COMPARATOR

Whole breast Radiotherapy, 40 Gray (40Gy) fractions

Radiation: Active Comparator: Standard

Experimental 1: Hypofractionated radiotherapy

EXPERIMENTAL

Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions

Radiation: Experimental 1: Hypofractionated radiotherapy

Experimental 2: Accelerated Partial Breast Irradiation

EXPERIMENTAL

Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.

Radiation: Experimental 2: Accelerated Partial Breast Irradiation

Interventions

Active Comparator: Standard RADIATION

Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks

Active Comparator: Standard

Experimental 1: Hypofractionated radiotherapy RADIATION

Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week

Experimental 1: Hypofractionated radiotherapy

Experimental 2: Accelerated Partial Breast Irradiation RADIATION

Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.

Experimental 2: Accelerated Partial Breast Irradiation

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Information to the patient and signed informed consent;
• Women aged ≥50 years
• Breast conserving surgery
• Pathologic tumor size \< 3 cm (maximum microscopic diameter of the invasive component)
• Invasive adenocarcinoma (except classic invasive lobular carcinoma)
• Unifocal disease
• Histopathologic grades I or II
• Eastern Cooperative Oncology Group (ECOG) 0-1
• Lymphovascular invasion absent
• Negative axillary lymph nodes
• Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
• No prior breast or mediastinal radiotherapy
• No hematogenous metastases

You may not qualify if:

• Previous malignancy (except non-melanomatous skin cancer)
• Mastectomy
• Classical-Type Invasive Lobular Carcinoma
• Neoadjuvant chemotherapy
• Human Epidermal growth factor Receptor-type 2 positive (HER2+)
• Triple-negative breast cancers
• Intravascular lymphoma present
• Contraindications to radiotherapy.
• No geographical, social or psychologic reasons that would prevent study follow

Sponsors & Collaborators

• Instituto Brasileiro de Controle do Cancer: lead

Study Sites (1)

IBCC Oncologia

São Paulo, São Paulo, 03102-002, Brazil

RECRUITING

Related Publications (11)

• Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.

  PMID: 22019144 BACKGROUND

• Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie 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.

  PMID: 26494415 BACKGROUND

• Polgar C, Fodor J, Major T, Sulyok Z, Kasler 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.

  PMID: 23742961 BACKGROUND

• Veronesi U, Orecchia R, Maisonneuve P, Viale G, Rotmensz N, Sangalli C, Luini A, Veronesi P, Galimberti V, Zurrida S, Leonardi MC, Lazzari R, Cattani F, Gentilini O, Intra M, Caldarella P, Ballardini B. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol. 2013 Dec;14(13):1269-77. doi: 10.1016/S1470-2045(13)70497-2. Epub 2013 Nov 11.

  PMID: 24225155 BACKGROUND

• 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.

  PMID: 23835717 BACKGROUND

• 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.

  PMID: 27866865 BACKGROUND

• 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.

  PMID: 25605582 BACKGROUND

• 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.

  PMID: 24055415 BACKGROUND

• Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.

  PMID: 32663119 BACKGROUND

• 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.

  PMID: 28779963 BACKGROUND

• Imielinski K. [Sexuality and personality]. Ginekol Pol. 1981 Mar;52(3):293-7. No abstract available. Polish.

  PMID: 7262592 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Eduardo Barbieri

CONTACT

+551198639-1945; edurxt@gmail.com

Alayne D Yamada, PhD

CONTACT

+55113474-4242; alayne.pesquisa@ibcc-mooca.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 17, 2020
• Study Start: March 4, 2021
• Primary Completion: December 7, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 8, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)