Radiotherapy After Primary Chemotherapy for Breastcancer

NCT01279304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 851

Last updated 2022-10-14

No results posted yet for this study

Summary

The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with \> 3 pathologic axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy, breast surgery, and radiotherapy that is protocolized based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).

Conditions

Interventions

RADIATION

radiation - no radiation see intervention description

after MRM in group 1 (low risk): no radiotherapy after BCT in group 1 (low risk): radiation treatment of the breast with boost (optional)

RADIATION

radiation: see intervention description

after BCT in group 2 (intermediate risk): radiation treatment of the breast with boost (optional) after MRM in group 2 (intermediate risk): radiation treatment of the thoracic wall If no full ALND is performed in group 2 (intermediate risk) add radiation treatment of level 1 and 2 of the axilla.

RADIATION

radiation: see intervention description

after MRM in group 3 (high risk): radiation treatment of the thoracic wall and supraclavicular nodes after BCT in group 3 (high risk): radiation treatment of the breast with boost (optional) and supraclavicular nodes If no full ALND is performed group 3 (high risk) add radiation treatment of level 1 and 2 of the axilla.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER
  • Diakonessenhuis, Utrecht

    collaborator OTHER
  • Maastricht Radiation Oncology

    lead OTHER

Principal Investigators

  • L.J Boersma · Maastricht University Medical Centre

  • A Voogd · Maastricht University

  • R Houben · Maastricht University Medical Centre

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Netherlands

Study Locations

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Entities

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 NCT01279304 on ClinicalTrials.gov