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Trial Title: Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer

NCT ID: NCT00892814

Condition: Breast Carcinoma

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Partial breast irradiation
Description: 40 Gy/15 fractions, 3 weeks
Arm group label: Partial breast irradiation

Intervention type: Radiation
Intervention name: Whole breast irradiation
Description: 40 Gy/15 fractions, 3 weeks
Arm group label: Whole breast irradiation

Summary: The purpose of this trial is to investigate the difference in late radiation morbidity between partial breast irradiation and whole breast irradiation given to women operated on with breast conservation surgery for early breast cancer with a low risk of local recurrence.

Detailed description: The study is 2-armed. In both treatment arms the radiotherapy consists of 40 Gy in 15 fractions, 2.67 Gy per fraction. The primary endpoint in the trial is late radiation morbidity evaluated as fibrosis, secondary endpoints are other types of late morbidity, rate of local recurrence and an attempt to establish a genetic risk profile for development of late radiation morbidity. The hypothesis is that women operated with breast conservation for a breast carcinoma with low risk of local recurrence can be offered partial breast irradiation without risking more late radiation morbidity compared to whole breast irradiation.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - women 60 years or older - operated for unilateral, unifocal early breast cancer pT1, pN0, M0, grade I or II, positive estrogen and/or progesterone receptor, HER2 negative Exclusion Criteria: - lobular carcinoma

Gender: Female

Minimum age: 60 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The Danish Breast Cancer Cooperative Group

Address:
City: Copenhagen
Zip: DK-2100
Country: Denmark

Start date: May 14, 2009

Completion date: March 2026

Lead sponsor:
Agency: Danish Breast Cancer Cooperative Group
Agency class: Other

Collaborator:
Agency: Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Agency class: Other

Collaborator:
Agency: Danish Cancer Society
Agency class: Other

Source: Danish Breast Cancer Cooperative Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00892814

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