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Partial Breast Versus no Irradiation for Women With Early Breast Cancer

Primary Purpose

Local Neoplasm Recurrence, Distantly Metastatic Malignant Neoplasm, Death

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
No partial breast irradiation
Sponsored by
Danish Breast Cancer Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Local Neoplasm Recurrence

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ponticia Universidad Catolica de ChileRecruiting
  • Aalborg University HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • RigshospitaletRecruiting
  • Herlev HospitalRecruiting
  • Naestved HospitalRecruiting
  • Odense University HospitalRecruiting
  • Vejle HospitalRecruiting
  • Haukeland HUSRecruiting
  • NordlandssykehusetRecruiting
  • Kristiansand HospitalRecruiting
  • Oslo University Hospital, RadiumhospitaletRecruiting
  • Stavanger HospitalRecruiting
  • Tromsø University HospitalRecruiting
  • Sahlgrenska University hospitalRecruiting
  • Skånes University HospitalRecruiting
  • Uppsala Akademiska SjukhusetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Partial breast irradiation

No partial breast irradiation

Arm Description

External beam irradiation 40 Gy / 15 fractions, 5 fractions per week, 3 weeks

No radiation therapy

Outcomes

Primary Outcome Measures

Invasive local recurrence
Invasive local recurrence

Secondary Outcome Measures

Regional nodes recurrence
Invasive recurrence in regional nodes of the treated breast
Distant failure
Invasive recurrence from the breast cancer outside the loco-regional area
Death
Death and cause of death

Full Information

First Posted
July 14, 2018
Last Updated
October 5, 2020
Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
Danish Cancer Society, Danish Center for Interventional Research in Radiation Oncology (CIRRO)
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1. Study Identification

Unique Protocol Identification Number
NCT03646955
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
September 1, 2033 (Anticipated)
Study Completion Date
September 1, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
Danish Cancer Society, Danish Center for Interventional Research in Radiation Oncology (CIRRO)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Local Neoplasm Recurrence, Distantly Metastatic Malignant Neoplasm, Death, Fibrosis Breast, Depigmentation/Hyperpigmentation of Skin, Telangiectasia, Scar, Pain, PROMs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinically controlled randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
926 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Partial breast irradiation
Arm Type
Active Comparator
Arm Description
External beam irradiation 40 Gy / 15 fractions, 5 fractions per week, 3 weeks
Arm Title
No partial breast irradiation
Arm Type
No Intervention
Arm Description
No radiation therapy
Intervention Type
Radiation
Intervention Name(s)
No partial breast irradiation
Intervention Description
Omission of radiation therapy
Primary Outcome Measure Information:
Title
Invasive local recurrence
Description
Invasive local recurrence
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Regional nodes recurrence
Description
Invasive recurrence in regional nodes of the treated breast
Time Frame
10 years
Title
Distant failure
Description
Invasive recurrence from the breast cancer outside the loco-regional area
Time Frame
10 years
Title
Death
Description
Death and cause of death
Time Frame
10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgitte V Offersen, PhD
Phone
+45 28838012
Email
bvo@oncology.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte V Offersen, PhD
Organizational Affiliation
Danish Breast Cancer Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ponticia Universidad Catolica de Chile
City
Santiago de Chile
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Merino Lara
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamas Lörinz, MD
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne M Nielsen, PhD
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Kamby, DMSc
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise W Matthiessen
Facility Name
Naestved Hospital
City
Naestved
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sami Al-Rawi, MD
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette H Nielsen, PhD
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Troels Bechmann, PhD
Facility Name
Haukeland HUS
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Petter Eikesdal
Facility Name
Nordlandssykehuset
City
Bodø
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bård Mannsåker
Facility Name
Kristiansand Hospital
City
Kristiansand
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Unn-Miriam Kasti
Facility Name
Oslo University Hospital, Radiumhospitalet
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Reinertsen
Facility Name
Stavanger Hospital
City
Stavanger
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingvil Mjaaland
Facility Name
Tromsø University Hospital
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Egil Blix Støre
Facility Name
Sahlgrenska University hospital
City
Göteborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Lundstedt
Facility Name
Skånes University Hospital
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Alkner
Facility Name
Uppsala Akademiska Sjukhuset
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Lindman

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
When the results from the trial are published, the DBCG RT Committee can decide that the results may be part of a meta-analysis.
IPD Sharing Time Frame
It will only be possible if the DBCG Radiation Therapy Committee decides that it is acceptable
IPD Sharing Access Criteria
The DBCG Radiation Therapy Committee will define the criteria after publication of the results from the trial

Learn more about this trial

Partial Breast Versus no Irradiation for Women With Early Breast Cancer

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