Partial Breast Versus no Irradiation for Women With Early Breast Cancer

Last updated: October 5, 2020
Sponsor: Danish Breast Cancer Cooperative Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Scleroderma

Pain

Treatment

N/A

Clinical Study ID

NCT03646955
DBCG RT Natural Trial
  • Ages > 60
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: 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

  • HER2 negative (by IHC and/or in situ hybridization)

  • resection margin >=2 mm for invasive carcinoma and any ductal carcinoma in situassociated with the cancer Surgical type is breast conservation Performance status ECOG 0-2 No evidence of distant metastasis

Exclusion

Exclusion Criteria:

  • 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, endometriumor coli, melanoma in situ.

  • comorbidity precluding the patient from radiation therapy (e.g. cardiovascular orpulmonary disease, scleroderma, systemic lupus erythematosus).

  • mental/psychiatric disorder which precludes the patient from understanding therandomization and the follow up.

  • documented hereditary breast cancer or with high genetic risk of breast cancer

  • life expectancy <10 years

Study Design

Total Participants: 926
Study Start date:
September 05, 2018
Estimated Completion Date:
September 01, 2035

Study 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.

Connect with a study center

  • Ponticia Universidad Catolica de Chile

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • Herlev Hospital

    Herlev,
    Denmark

    Active - Recruiting

  • Naestved Hospital

    Naestved,
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense,
    Denmark

    Active - Recruiting

  • Vejle Hospital

    Vejle,
    Denmark

    Active - Recruiting

  • Haukeland HUS

    Bergen,
    Norway

    Active - Recruiting

  • Nordlandssykehuset

    Bodø,
    Norway

    Active - Recruiting

  • Kristiansand Hospital

    Kristiansand,
    Norway

    Active - Recruiting

  • Oslo University Hospital, Radiumhospitalet

    Oslo,
    Norway

    Active - Recruiting

  • Stavanger Hospital

    Stavanger,
    Norway

    Active - Recruiting

  • Tromsø University Hospital

    Tromsø,
    Norway

    Active - Recruiting

  • Sahlgrenska University hospital

    Göteborg,
    Sweden

    Active - Recruiting

  • Skånes University Hospital

    Lund,
    Sweden

    Active - Recruiting

  • Uppsala Akademiska Sjukhuset

    Uppsala,
    Sweden

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.