Partial Breast Versus no Irradiation for Women With Early Breast Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorDanish Breast Cancer Cooperative Group

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • No partial breast irradiation

    Radiation

    Omission of radiation therapy

Treatment groups

926 Participants
are divided into 2 treatment groups
Group A: Partial breast irradiationActive comparator 1 intervention
Group B: No partial breast irradiationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Invasive local recurrence

Invasive local recurrence

Time frame
10 years

Secondary outcomes

1

Regional nodes recurrence

Invasive recurrence in regional nodes of the treated breast

Time frame
10 years
2

Distant failure

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

Time frame
10 years
3

Death

Death and cause of death

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danish Breast Cancer Cooperative Group

Lead sponsor

Danish Cancer Society

Collaborator

Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Collaborator