NCT02104895

Brief Summary

The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Mar 2005

Typical duration for phase_3 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

July 1, 2016

Enrollment Period

8.3 years

First QC Date

April 2, 2014

Results QC Date

November 25, 2015

Last Update Submit

July 11, 2016

Conditions

Breast Cancer

Keywords

Breast cancerEarly breast cancerAdjuvant breast cancerAccelerated partial breast irradiationIntensity modulated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Ipsilateral Breast Tumor Recurrence

    We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"

    5-year

Secondary Outcomes (2)

  • Acute Skin Toxicity

    5 years

  • Excellent Cosmesis

    5 years

Study Arms (2)

Whole breast irradiation (WBI)

ACTIVE COMPARATOR

Conventional whole breast irradiation (WBI)

Radiation: Whole breast irradiation (WBI)

Partial breast irradiation (APBI)

EXPERIMENTAL

Accelerated partial breast irradiation (APBI)

Radiation: Accelerated partial breast irradiation (APBI)

Interventions

Accelerated partial breast irradiation (APBI)RADIATION

Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)

Partial breast irradiation (APBI)
Whole breast irradiation (WBI)RADIATION

Conventional whole breast irradiation (WBI)

Whole breast irradiation (WBI)

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at presentation \>40 y
  • Tumor size \<25 mm
  • Wide excision or quadrantectomy with clear margins (\>5 mm)
  • Clips placed in tumor bed
  • Full informed consent from patient

You may not qualify if:

  • Cardiac dysfunction
  • Forced expiratory volume in 1 second (FEV1) \<1 L/m
  • Extensive intraductal carcinoma
  • Multifocal cancer
  • Psychiatric problems
  • Recurrent breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Livi L, Buonamici FB, Simontacchi G, Scotti V, Fambrini M, Compagnucci A, Paiar F, Scoccianti S, Pallotta S, Detti B, Agresti B, Talamonti C, Mangoni M, Bianchi S, Cataliotti L, Marrazzo L, Bucciolini M, Biti G. Accelerated partial breast irradiation with IMRT: new technical approach and interim analysis of acute toxicity in a phase III randomized clinical trial. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):509-15. doi: 10.1016/j.ijrobp.2009.04.070. Epub 2009 Aug 21.

    PMID: 19700248RESULT

  • 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: 25605582RESULT

  • Meattini I, Saieva C, Marrazzo L, Di Brina L, Pallotta S, Mangoni M, Meacci F, Bendinelli B, Francolini G, Desideri I, De Luca Cardillo C, Scotti V, Furfaro IF, Rossi F, Greto D, Bonomo P, Casella D, Bernini M, Sanchez L, Orzalesi L, Simoncini R, Nori J, Bianchi S, Livi L. Accelerated partial breast irradiation using intensity-modulated radiotherapy technique compared to whole breast irradiation for patients aged 70 years or older: subgroup analysis from a randomized phase 3 trial. Breast Cancer Res Treat. 2015 Oct;153(3):539-47. doi: 10.1007/s10549-015-3565-2. Epub 2015 Sep 9.

    PMID: 26350524RESULT

  • 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.

    PMID: 32840419DERIVED

  • Becherini C, Meattini I, Livi L, Garlatti P, Desideri I, Scotti V, Orzalesi L, Sanchez LJ, Bernini M, Casella D, Nesi S, Nori J, Bianchi S, Pallotta S, Marrazzo L. External accelerated partial breast irradiation for ductal carcinoma in situ: long-term follow-up from a phase 3 randomized trial. Tumori. 2019 Jun;105(3):205-209. doi: 10.1177/0300891618811278. Epub 2018 Nov 26.

    PMID: 30474504DERIVED

  • Meattini I, Saieva C, Miccinesi G, Desideri I, Francolini G, Scotti V, Marrazzo L, Pallotta S, Meacci F, Muntoni C, Bendinelli B, Sanchez LJ, Bernini M, Orzalesi L, Nori J, Bianchi S, Livi L. Accelerated partial breast irradiation using intensity modulated radiotherapy versus whole breast irradiation: Health-related quality of life final analysis from the Florence phase 3 trial. Eur J Cancer. 2017 May;76:17-26. doi: 10.1016/j.ejca.2017.01.023. Epub 2017 Mar 3.

    PMID: 28262584DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Icro Meattini
Organization
Radiation-Oncology Unit, AOU Careggi, Florence University, Florence, Italy
icro.meattini@unifi.it
+39055794

Study Officials

  • Lorenzo Livi, Full Prof

    Florence University

    PRINCIPAL INVESTIGATOR

  • Icro Meattini, M.D.

    Azienda Ospedaliero-Universitaria Careggi

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor; Chief Radiotherapy-Oncology Unit; Florence University

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 7, 2014

Study Start

March 1, 2005

Primary Completion

June 1, 2013

Study Completion

February 1, 2014

Last Updated

August 11, 2016

Results First Posted

July 11, 2016

Record last verified: 2016-07