Partial Breast Versus no Irradiation for Women With Early Breast Cancer

• ClinicalTrials.gov Identifier: NCT03646955
• Recruitment Status: Recruiting
• First Posted: August 24, 2018
• Last Update Posted: October 6, 2020
• Sponsor: Danish Breast Cancer Cooperative Group
• 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

Tracking Information

• First Submitted Date: July 14, 2018
• First Posted Date: August 24, 2018
• Last Update Posted Date: October 6, 2020
• Actual Study Start Date: September 5, 2018
• Estimated Primary Completion Date: September 1, 2033 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2018)

Invasive local recurrence [ Time Frame: 10 years ]

Invasive local recurrence

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 23, 2018)

• Regional nodes recurrence [ Time Frame: 10 years ]
  Invasive recurrence in regional nodes of the treated breast
• Distant failure [ Time Frame: 10 years ]
  Invasive recurrence from the breast cancer outside the loco-regional area
• Death [ Time Frame: 10 years ]
  Death and cause of death

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Clinically controlled randomized trial

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

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

Intervention

Radiation: No partial breast irradiation

Omission of radiation therapy

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 23, 2018): 926
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2035
• Estimated Primary Completion Date: September 1, 2033 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Chile, Denmark, Norway, Sweden

Administrative Information

• NCT Number: NCT03646955
• Other Study ID Numbers: DBCG RT Natural Trial
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

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

• Current Responsible Party: Birgitte Offersen, Danish Breast Cancer Cooperative Group
• Original Responsible Party: Same as current
• Current Study Sponsor: Danish Breast Cancer Cooperative Group
• Original Study Sponsor: Same as current

Collaborators

• Danish Cancer Society
• Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Investigators

• Principal Investigator: Birgitte V Offersen, PhD; Danish Breast Cancer Group

• PRS Account: Danish Breast Cancer Cooperative Group
• Verification Date: October 2020