Partial Breast Versus no Irradiation for Women With Early Breast Cancer

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646955
• Other study ID #: DBCG RT Natural Trial
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: September 1, 2035

Study information

• Verified date: October 2020
• Source: Danish Breast Cancer Cooperative Group
• Contact: Birgitte V Offersen, PhD
• Phone: +45 28838012
• Email: bvo[@]oncology.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 926
• Est. completion date: September 1, 2035
• Est. primary completion date: September 1, 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• No partial breast irradiation
Omission of radiation therapy

Locations

Country	Name	City	State
Chile	Ponticia Universidad Catolica de Chile	Santiago de Chile
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Naestved Hospital	Naestved
Denmark	Odense University Hospital	Odense
Denmark	Vejle Hospital	Vejle
Norway	Haukeland HUS	Bergen
Norway	Nordlandssykehuset	Bodø
Norway	Kristiansand Hospital	Kristiansand
Norway	Oslo University Hospital, Radiumhospitalet	Oslo
Norway	Stavanger Hospital	Stavanger
Norway	Tromsø University Hospital	Tromsø
Sweden	Sahlgrenska University hospital	Göteborg
Sweden	Skånes University Hospital	Lund
Sweden	Uppsala Akademiska Sjukhuset	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Danish Breast Cancer Cooperative Group	Danish Cancer Society, Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Countries where clinical trial is conducted

Chile,  Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive local recurrence	Invasive local recurrence	10 years
Secondary	Regional nodes recurrence	Invasive recurrence in regional nodes of the treated breast	10 years
Secondary	Distant failure	Invasive recurrence from the breast cancer outside the loco-regional area	10 years
Secondary	Death	Death and cause of death	10 years