Clinical trial NCT03646955: Partial Breast Versus no Irradiation for Women With Early Breast Cancer
Official title: The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Local Neoplasm Recurrence
Distantly Metastatic Malignant Neoplasm
Death
Fibrosis Breast
Depigmentation/Hyperpigmentation of Skin
Telangiectasia
Scar
Pain
PROMs
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Danish Center for Interventional Research in Radiation Oncology (CIRRO)
First posted: 2018-08-24
Enrollment: 926
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinically controlled randomized trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 situ associated with the cancer

Surgical type is breast conservation

Performance status ECOG 0-2

No evidence of distant metastasis

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, endometrium or coli, melanoma in situ.
* comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
* mental/psychiatric disorder which precludes the patient from understanding the randomization and the follow up.
* documented hereditary breast cancer or with high genetic risk of breast cancer
* life expectancy \<10 years

Primary outcomes:
measure: Invasive local recurrence
timeFrame: 10 years
Secondary outcomes:
measure: Regional nodes recurrence
timeFrame: 10 years
measure: Distant failure
timeFrame: 10 years
measure: Death
timeFrame: 10 years
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Ponticia Universidad Catolica de Chile
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Naestved
country: Denmark
facility: Naestved Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Bergen
country: Norway
facility: Haukeland HUS
city: Bodø
country: Norway
facility: Nordlandssykehuset
city: Kristiansand
country: Norway
facility: Kristiansand Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Radiumhospitalet
city: Stavanger
country: Norway
facility: Stavanger Hospital
city: Tromsø
country: Norway
facility: Tromsø University Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University hospital
city: Lund
country: Sweden
facility: Skånes University Hospital
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Sjukhuset
Study officials:
affiliation: Danish Breast Cancer Group
name: Birgitte V Offersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: