Skip to content
Triangle logo TriangleGet started
← Study library

NCT02104895 · CITED IN SOURCE DOCUMENTS

Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2016-08-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Ipsilateral Breast Tumor Recurrence

→

outcome · POSTED

Acute Skin Toxicity

→

outcome · POSTED

Excellent Cosmesis

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Cardiac dysfunction * Forced expiratory volume in 1 second (FEV1) \<1 L/m * Extensive intraductal carcinoma * Multifocal cancer * Psychiatric problems * Recurrent breast cancer
healthy Volunteers
false
minimum Age
40 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Conventional whole breast irradiation (WBI)
    intervention Names
    1. Radiation: Whole breast irradiation (WBI)
    label
    Whole breast irradiation (WBI)
    type
    ACTIVE_COMPARATOR
  2. description
    Accelerated partial breast irradiation (APBI)
    intervention Names
    1. Radiation: Accelerated partial breast irradiation (APBI)
    label
    Partial breast irradiation (APBI)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Partial breast irradiation (APBI)
    description
    Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
    name
    Accelerated partial breast irradiation (APBI)
    type
    RADIATION
  2. arm Group Labels
    1. Whole breast irradiation (WBI)
    description
    Conventional whole breast irradiation (WBI)
    name
    Whole breast irradiation (WBI)
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
520
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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"
    measure
    Ipsilateral Breast Tumor Recurrence
    time Frame
    5-year
secondary Outcomes
  1. description
    Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced "Acute skin toxicity ≥ grade 2
    measure
    Acute Skin Toxicity
    time Frame
    5 years
  2. description
    Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects
    measure
    Excellent Cosmesis
    time Frame
    5 years
Full study description
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.
detailed Description
The surgeons were requested to place clips at the borders of the surgical bed, using a minimum of four clips. The presence of surgical clips was a selection criterion to avoid geographic misses. Computed tomography (CT) scanning was performed using 0.3-cm thick-slices and a slice spacing of 0.3 cm. In patients assigned to APBI arm, the clinical target volume (CTV) was drawn with a uniform 1-cm three-dimensional margin around the surgical clips. The CTV was limited to 3 mm from the skin surface and 3 mm from the lung-chest wall interface. A second uniform, three-dimensional 1-cm margin was added to the CTV to obtain the planning target volume (PTV). The PTV was allowed to extend 4 mm inside the ipsilateral lung and was limited to 3 mm from the skin. The ipsilateral and contralateral breast, ipsilateral and contralateral lung, heart, and spinal cord were contoured as organs at risk. All the regions of interest were contoured according to the International Commission on Radiation Units and Measurements reports 50 and 62 recommendations. No respiratory control was used. Concerning the experimental Arm (accelerated partial breast irradiation), a dose of 30 Gy in five fractions at 6 Gy/fraction was prescribed. The following constraints were adopted for plan optimization: PTV coverage: 100% of PTV covered by 95% of the prescribed dose (V28.5 = 100%); maximal dose to PTV \<105% (31.5 Gy); minimal dose to PTV 28 Gy; uninvolved breast (i.e., ipsilateral breast without PTV): not \>50% covered by a dose of \>50% of the prescribed dose (V15 \<50%); ipsilateral lung: not \>20% covered by a dose \>10 Gy (V10\<20%); contralateral lung: not \>10% covered by a dose \>5 Gy (V5\<10%); contralateral breast: maximal dose \<1 Gy; heart: not \>10% covered by a dose \>3 Gy (V3 \<10%).
Source references
references
  1. citation
    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
    19700248
    type
    RESULT
  2. citation
    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
    type
    RESULT
  3. citation
    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
    26350524
    type
    RESULT
  4. citation
    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
    32840419
    type
    DERIVED
  5. citation
    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
    30474504
    type
    DERIVED
  6. citation
    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
    28262584
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-80a872ecc2d29d744f94
      requested nct id
      NCT02104895
      primary nct id
      NCT02104895
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      payload sha256
      f8a22ef11d58f759b34684149dd12588a72f4a14de0e05cc92eb11e3da49b37c
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-80a872ecc2d29d744f94
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT02104895
      occurrences
      1. context exact
        nal&amp;language=English'); return(false);">Level of evidence B1</a>]</li></ul></div></li><li>The randomized, phase III, single-center <a href="/clinicaltrials/NCT02104895">APBI-IMRT-Florence</a> trial (NCT02104895) evaluated differences in ipsilateral breast tumor recurrence (IBTR) among patients who received APBI using either
        end
        235550
        exact text
        NCT02104895
        start
        235539
      2. context exact
        >Level of evidence B1</a>]</li></ul></div></li><li>The randomized, phase III, single-center <a href="/clinicaltrials/NCT02104895">APBI-IMRT-Florence</a> trial (NCT02104895) evaluated differences in ipsilateral breast tumor recurrence (IBTR) among patients who received APBI using either intensity-modulated radiation therapy, an
        end
        235593
        exact text
        NCT02104895
        start
        235582
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/29bf1e5a1d739974ed.html
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:35.419733+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      536430925e3b0008edd3fb69a869d5645bd6b6dc5c84c21ddf1b3e24f089874c
      source title
      Breast Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice