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Partial Breast Versus no Irradiation for Women With Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT03646955
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Danish Cancer Society
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
Birgitte Offersen, Danish Breast Cancer Cooperative Group

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.

Condition or disease Intervention/treatment Phase
Local Neoplasm Recurrence Distantly Metastatic Malignant Neoplasm Death Fibrosis Breast Depigmentation/Hyperpigmentation of Skin Telangiectasia Scar Pain PROMs Radiation: No partial breast irradiation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 926 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinically controlled randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : September 1, 2033
Estimated Study Completion Date : September 1, 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Partial breast irradiation
External beam irradiation 40 Gy / 15 fractions, 5 fractions per week, 3 weeks
Radiation: No partial breast irradiation
Omission of radiation therapy

No Intervention: No partial breast irradiation
No radiation therapy



Primary Outcome Measures :
  1. Invasive local recurrence [ Time Frame: 10 years ]
    Invasive local recurrence


Secondary Outcome Measures :
  1. Regional nodes recurrence [ Time Frame: 10 years ]
    Invasive recurrence in regional nodes of the treated breast

  2. Distant failure [ Time Frame: 10 years ]
    Invasive recurrence from the breast cancer outside the loco-regional area

  3. Death [ Time Frame: 10 years ]
    Death and cause of death



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646955


Contacts
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Contact: Birgitte V Offersen, PhD +45 28838012 bvo@oncology.au.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Tamas Lörinz, MD         
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Hanne M Nielsen, PhD         
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Claus Kamby, DMSc         
Naestved Hospital Recruiting
Naestved, Denmark
Contact: Sami Al-Rawi, MD         
Odense University Hospital Recruiting
Odense, Denmark
Contact: Mette H Nielsen, PhD         
Vejle Hospital Recruiting
Vejle, Denmark
Contact: Troels Bechmann, PhD         
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Investigators
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Principal Investigator: Birgitte V Offersen, PhD Danish Breast Cancer Group

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Responsible Party: Birgitte Offersen, Professor, PhD, MD, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier: NCT03646955     History of Changes
Other Study ID Numbers: DBCG RT Natural Trial
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: It will only be possible if the DBCG Radiation Therapy Committee decides that it is acceptable
Access Criteria: The DBCG Radiation Therapy Committee will define the criteria after publication of the results from the trial

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms
Recurrence
Telangiectasis
Neoplasms, Second Primary
Hyperpigmentation
Hypopigmentation
Neoplasm Recurrence, Local
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Pigmentation Disorders
Skin Diseases
Neoplastic Processes