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

Breast Carcinoma Clinical Trial

Official title:

Partial Breast Versus Whole Breast Irradiation to Women ≥ 60 Years Operated With Breast Conservation for Early Breast Cancer: a Randomized Fase II Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00892814
• Other study ID #: DBCG PBI protocol
• Secondary ID: CIRRO IP030109
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 14, 2009
• Est. completion date: March 2026

Study information

• Verified date: February 2020
• Source: Danish Breast Cancer Cooperative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 882
• Est. completion date: March 2026
• Est. primary completion date: March 7, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Radiation:
• Partial breast irradiation
40 Gy/15 fractions, 3 weeks
• Whole breast irradiation
40 Gy/15 fractions, 3 weeks

Locations

Country	Name	City	State
Denmark	The Danish Breast Cancer Cooperative Group	Copenhagen	Copenhagen Ø

Sponsors (3)

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

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Offersen BV, Overgaard M, Kroman N, Overgaard J. Accelerated partial breast irradiation as part of breast conserving therapy of early breast carcinoma: a systematic review. Radiother Oncol. 2009 Jan;90(1):1-13. doi: 10.1016/j.radonc.2008.08.005. Epub 2008 Sep 8. Review. Erratum in: Radiother Oncol. 2011 Feb;98(2):254. Radiother Oncol. 2011 May;99(2):254. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 2 and/or 3 fibrosis after radiotherapy		3 years
Secondary	Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival	morbidity and recurrences	10 years