NCT00909818

Brief Summary

The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
976

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

May 14, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

15 years

First QC Date

May 28, 2009

Last Update Submit

August 23, 2021

Conditions

Breast CancerCarcinoma in Situ of the Breast

Outcome Measures

Primary Outcomes (1)

  • Grade 2 or 3 fibrosis 3 years after radiotherapy

    3 years

Secondary Outcomes (1)

  • Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival

    10 years

Study Arms (2)

standard fractionated radiotherapy

ACTIVE COMPARATOR

50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week

Radiation: standard fractionated radiotherapy

hypofractionated radiotherapy

EXPERIMENTAL

hypofractionated radiotherapy 40 Gy/15 fractions

Radiation: hypofractionated radiotherapy

Interventions

standard fractionated radiotherapyRADIATION

standard fractionated radiotherapy 50 Gy/25 fractions

standard fractionated radiotherapy
hypofractionated radiotherapyRADIATION

hypofractionated radiotherapy 40 Gy/15 fractions

hypofractionated radiotherapy

Eligibility Criteria

Age41 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • operated with breast conserving strategy for:
  • invasive breast cancer, pT1-2, pN0-1mi, M0 OR
  • carcinoma in situ of the breast

You may not qualify if:

  • previous radiation of the breast/thorax
  • breast implants
  • pregnant/lactating
  • comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Danish Breast Cancer Cooperative Group

Copenhagen, DK-2100 Ø, Denmark

Location

Related Publications (1)

  • Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10.

    PMID: 32910709DERIVED

MeSH Terms

Conditions

Breast NeoplasmsBreast Carcinoma In Situ

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Lars Stenbygaard, MD

    Aalborg University Hospital

    STUDY CHAIR

  • Birgitte Offersen, MD, Ph.D

    Aarhus University Hospital

    STUDY CHAIR

  • Erik Jakobsen, MD

    Vejle Hospital

    STUDY CHAIR

  • Mette H Nielsen, MD, phd

    Odense University Hospital

    STUDY CHAIR

  • Birgitte Offersen, MD, phd

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Mechthild Krause, M.D., Prof

    University Clinic Carl Gustav Carus Dresden

    STUDY CHAIR

  • Andreas Schreiber, M.D., Ph.D.

    Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt

    STUDY CHAIR

  • Ingvil Mjaaland, M.D.

    Helse Stavanger HF, Sorlandet Sykehus HF

    STUDY CHAIR

  • Unn-Miriam Kasti, M.D.

    Kristiansand Sykehus

    STUDY CHAIR

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
M.D., ph.d., associate professor

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

May 14, 2009

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations

DK(1)