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Local Neoplasm RecurrenceNCT03646955

Partial Breast Versus no Irradiation for Women With Early Breast Cancer

A study testing No partial breast irradiation in people with Local Neoplasm Recurrence and Distantly Metastatic Malignant Neoplasm, run by Danish Breast Cancer Cooperative Group at 17 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. Read more about this study

Who is it for?
Ages 60 years and older, women only
What is being tested?
No partial breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
926 participants
Where
17 sitesin 4 countries
Study dates
5 Sep 2018to 1 Sep 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Female patient >=60 years
  • Primary tumour characteristics by conventional histopathology
  • unilateral and unifocal non-lobular histology grade 1-2
  • maximum microscopic size <=20mm
  • node negative determined by sentinel node or axillary lymph node dissection
  • estrogen receptor >=10% positive
Show all 11Show fewer
  • HER2 negative (by IHC and/or in situ hybridization)
  • resection margin >=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer
  • Surgical type is breast conservation
  • Performance status ECOG 0-2
  • No evidence of distant metastasis

Who cannot join

  • multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
  • evidence of clinical or pathological T4 breast cancer
  • grade 3 malignancy
  • previous breast cancer or DCIS irrespective of disease-free interval
  • previous radiation therapy to the breast or thorax,
  • previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.
Show all 10Show fewer
  • comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
  • mental/psychiatric disorder which precludes the patient from understanding the randomization and the follow up.
  • documented hereditary breast cancer or with high genetic risk of breast cancer
  • life expectancy <10 years

Trial locations and contacts

17 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Birgitte V Offersen, PhD contact

+45 28838012

bvo@oncology.au.dk

17 sites in 4 countries

Denmark7 sites, 7 recruiting

  • Aalborg University Hospital

    Aalborg

    Tamas Lörinz, MD

    Recruiting

  • Aarhus University Hospital

    Aarhus

    Hanne M Nielsen, PhD

    Recruiting

  • Rigshospitalet

    Copenhagen

    Claus Kamby, DMSc

    Recruiting

  • Herlev Hospital

    Herlev

    Louise W Matthiessen

    Recruiting

  • Naestved Hospital

    Næstved

    Sami Al-Rawi, MD

    Recruiting

  • Odense University Hospital

    Odense

    Mette H Nielsen, PhD

    Recruiting

  • Vejle Hospital

    Vejle

    Troels Bechmann, PhD

    Recruiting

Other trials in Denmark

Norway6 sites, 6 recruiting

  • Haukeland HUS

    Bergen

    Hans Petter Eikesdal

    Recruiting

  • Nordlandssykehuset

    Bodø

    Bård Mannsåker

    Recruiting

  • Kristiansand Hospital

    Kristiansand

    Unn-Miriam Kasti

    Recruiting

  • Oslo University Hospital, Radiumhospitalet

    Oslo

    Kristin Reinertsen

    Recruiting

  • Stavanger Hospital

    Stavanger

    Ingvil Mjaaland

    Recruiting

  • Tromsø University Hospital

    Tromsø

    Egil Blix Støre

    Recruiting

Other trials in Norway

Sweden3 sites, 3 recruiting

  • Sahlgrenska University hospital

    Gothenburg

    Dan Lundstedt

    Recruiting

  • Skånes University Hospital

    Lund

    Sara Alkner

    Recruiting

  • Uppsala Akademiska Sjukhuset

    Uppsala

    Henrik Lindman

    Recruiting

Other trials in Sweden

Chile1 site, 1 recruiting

  • Ponticia Universidad Catolica de Chile

    Santiago

    Tomas Merino Lara

    Recruiting

Other trials in Chile

About this study

Official title: The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial

All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.

Read the detailed description

International standard of therapy is to provide adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer to lower the risk of local and distant failures. However, breast cancer is a heterogeneous disease, and the gain from RT in selected low risk patients is low. RT may cause acute and late side effects, and some of these may be serious to the patient. Therefore, there is a need to tailor RT utilization to the individual recurrence risk and try identify patients who are unlikely to gain much risk reduction from RT, because those patients can then omit RT and thereby avoid late effects and over-treatment. At the present time there is no consensus as to define the selection criteria for patients who may omit RT.

Based on early results from the randomized DBCG RT PBI trial, external beam 40 Gy/15 fr partial breast irradiation (PBI) has been standard in Denmark since April 2016 for selected low risk breast cancer patients. Based on results from the UK IMPORT LOW trial, the 5 yr local recurrence risk using this technique for PBI is 0.5%, whilst 2% for developing a new contralateral breast cancer.

This trial will investigate if PBI can safely be omitted in selected low risk breast cancer patients without causing unacceptable high risk of local failure.

Being tested
No partial breast irradiation
Medical subject headings
Neoplasm Recurrence, Local, Death, Vitiligo, Hyperpigmentation, Telangiectasis, Cicatrix, Pain

What participants receive

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

  • No partial breast irradiationRadiation

    Omission of radiation therapy

Study groups in NCT03646955
Study groupRoleWhat they receive
Partial breast irradiationActive comparatorExternal beam irradiation 40 Gy / 15 fractions, 5 fractions per week, 3 weeks
Receives: Radiation: No partial breast irradiation
No partial breast irradiationNo interventionNo radiation therapy

What is being measured

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

  1. Invasive local recurrence

    Invasive local recurrence

    Measured: 10 years

Secondary outcomes (3)

  1. Regional nodes recurrence

    Invasive recurrence in regional nodes of the treated breast

    Measured: 10 years

  2. Distant failure

    Invasive recurrence from the breast cancer outside the loco-regional area

    Measured: 10 years

  3. Death

    Death and cause of death

    Measured: 10 years

Timeline

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

  1. First posted24 Aug 2018
  2. Study start5 Sep 2018
  3. Primary completion1 Sep 2033 (estimated)
  4. Study completion1 Sep 2035 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Clinically controlled randomized trial
Masking
None (open label)
Enrolment
926 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03646955
Sponsor's protocol ID
DBCG RT Natural Trial
Status last verified
Oct 2020
First submitted
14 Jul 2018
Last updated
6 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: When the results from the trial are published, the DBCG RT Committee can decide that the results may be part of a meta-analysis.

Questions about this trial

What is this clinical trial studying?

A study testing No partial breast irradiation in people with Local Neoplasm Recurrence and Distantly Metastatic Malignant Neoplasm, run by Danish Breast Cancer Cooperative Group at 17 sites in 4 countries.

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 10 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: looking for participants now, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Denmark, Norway, Sweden, Chile. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Birgitte V Offersen, PhD (+45 28838012, bvo@oncology.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive local recurrence (time frame: 10 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 NCT03646955.

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 6 Oct 2020.

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