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Breast CancerPhase 2APERTNCT02003560

Accelerated Partial Breast Irradiation With 3D-CRT and IMRT

A Phase 2 study testing accelerated partial breast irradiation in people with Breast Cancer and Radiation Toxicity, run by National Institute of Oncology, Hungary at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine in a phase II clinical trial whether accelerated partial breast irradiation after breast conserving surgery using 3 dimensional external beam radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive breast cancer patients is safe without causing… Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Cancer, Radiation Toxicity, Side Effects
What is being tested?
accelerated partial breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteHungary
Study dates
Dec 2006to Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • previous breast conserving surgery within 12 weeks (in case of adjuvant chemotherapy within 28 days after completion of chemotherapy)
  • patient age > 40 years
  • ECOG performance status: 0-1
  • life expectancy >5 years
  • invasive ductal, papillary, mucinous, medullary or tubular carcinoma
  • unifocal tumor
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  • pathological tumor size < or = 30 mm
  • pathological negative axillary nodal status with axillary dissection or sentinel lymph node biopsy
  • surgical clips in the tumor bed
  • pathological surgical free margins of at least 2 mm
  • written informed consent of patients

Who cannot join

  • Stage III-IV
  • multifocal tumor
  • extensive intraductal component (EIC)
  • ductal or lobular carcinoma in situ (DCIS or LCIS)
  • invasive lobular cancer (ILC)
  • lymph-vascular invasion (LVI)
Show all 12Show fewer
  • contralateral breast cancer
  • history of treatment for previous breast cancer
  • lactation or breast feeding women
  • Paget-disease of the nipple
  • psychiatric disorder
  • increased radiosensitivity (e.g. collagen vascular disease)

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • National Institute of Oncology

    Budapest, H-1122

Other trials in Hungary

About this study

Official title: Accelerated Partial Breast Irradiation After Breast Conserving Surgery for Low-risk Invasive Breast Cancer: 3D Conformal Radiotherapy (3D-CRT) and Intensity Modulated Radiotherapy (IMRT) - Prospective Phase II Study

The purpose of this study is to determine in a phase II clinical trial whether accelerated partial breast irradiation after breast conserving surgery using 3 dimensional external beam radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive breast cancer patients is safe without causing serious late radiation side-effects.

Read the detailed description

It is a sequential phase II trial. Eligible patients after breast conserving surgery (BCS) are treated with accelerated partial breast irradiation (APBI) using three-dimensional conformal radiotherapy (3D-CRT) for the first 45 patients or intensity modulated radiotherapy (IMRT) for the second 45 patients.

Primary end-point of the study: late radiation side-effects at 5 years. Early stopping criteria: Not used as primary end-point is late side-effects. Interim analysis: Not planned Secondary end-points: cosmetic results, quality of life, local recurrence-free survival, regional recurrence free survival, distant metastasis free survival, relapse free survival, overall survival, cancer specific survival.

Null-hypothesis for primary end-point: The incidence of severe (>G2) late radiation side-effects after APBI using 3D-CRT or IMRT will not exceed 10%.

Stratification:

  • by treatment delivery: 3D-CRT - first 45 patients; IMRT - second 45 patients
  • by bra capsize: Capsize A-B; C; and D-D+

Treatment intervention: 9 x 4.1 Gy APBI using 3D-CRT (first 45 patients) or IMRT (second 45 patients) delivered within 5 days, using twice-a-day fractionation.

Clinical target volume (CTV) and Planning target volume (PTV) definition:

CTV = excision cavity + 20 mm minus the actual pathological surgical margin in mm PTV = CTV + 5 mm in each direction

Follow-up:

  • ECOG PS, physical examination (inspection and palpation), registration of side-effects (RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer)) early and late radiation morbidity scoring scheme) and cosmetic results (using the Harvard scale) : 7-14 days after RT, than in every 3 months for 2 years, and every 6 months for 5 years.
  • Mammography: at 6, 12, 18, 24 months, and annually thereafter
  • Quality of life questionnaire (QLQ) (e.g. EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and Breast (BR)-23) before RT, at 7-14 days after RT, at 3, 6, and 12 months, and annually thereafter
  • digital photography: before treatment, at 7-14 days after treatment, and yearly thereafter
Being tested
accelerated partial breast irradiation
Keywords
breast cancer, breast conserving therapy, accelerated partial breast irradiation, 3D conformal radiotherapy, intensity modulated radiotherapy
Medical subject headings
Breast Neoplasms, Radiation Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • accelerated partial breast irradiationRadiation

    9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.

Study groups in NCT02003560
Study groupRoleWhat they receive
Accelerated partial breast irradiationExperimentalAccelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
Receives: Radiation: accelerated partial breast irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. late radiation side-effect

    Late radiation side-effects at 5 years scored by the RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer) late radiation morbidity scoring scheme

    Measured: 5 years

Secondary outcomes (6)

  1. cosmetic results

    cosmetic results at 5 years measured by the Harvard criteria

    Measured: 5 years

  2. local tumor control

    Local tumor control defined as reappearance of the tumor in the ipsilateral breast

    Measured: 5 years

  3. regional tumor control

    regional tumor control at 5 years

    Measured: 5 years

  4. overall survival

    overall survival at 5 years

    Measured: 5 years

  5. disease free survival

    disease free survival at 5 years

    Measured: 5 years

  6. cancer specific survival

    cancer specific survival at 5 years

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2013 (estimated)
  2. Study startDec 2006
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02003560
Sponsor's protocol ID
NIO-APERT_01
Acronym
APERT
Status last verified
Aug 2014
First submitted
2 Dec 2013
Last updated
13 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • Mozsa E, Meszaros N, Major T, Frohlich G, Stelczer G, Sulyok Z, Fodor J, Polgar C. Accelerated partial breast irradiation with external beam three-dimensional conformal radiotherapy. Five-year results of a prospective phase II clinical study. Strahlenther Onkol. 2014 May;190(5):444-50. doi: 10.1007/s00066-014-0633-1. Epub 2014 Mar 12.

    PubMed 24619017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing accelerated partial breast irradiation in people with Breast Cancer and Radiation Toxicity, run by National Institute of Oncology, Hungary at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

late radiation side-effect (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02003560, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014; AzTrials last refreshed its copy on 30 Oct 2026.

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