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Partial Breast Versus no Irradiation for Women With Early Breast Cancer

NCT03646955 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 926

Last updated 2020-10-06

No results posted yet for this study

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. 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.

Conditions

  • Local Neoplasm Recurrence
  • Distantly Metastatic Malignant Neoplasm
  • Death
  • Fibrosis Breast
  • Depigmentation/Hyperpigmentation of Skin
  • Telangiectasia
  • Scar
  • Pain
  • PROMs

Interventions

RADIATION

No partial breast irradiation

Omission of radiation therapy

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • Danish Center for Interventional Research in Radiation Oncology (CIRRO)

    collaborator OTHER

  • Danish Breast Cancer Cooperative Group

    lead OTHER

Principal Investigators

  • Birgitte V Offersen, PhD · Danish Breast Cancer Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2033-09-01
Completion
2035-09-01

Countries

  • Chile
  • Denmark
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646955 on ClinicalTrials.gov