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


Phase 2
60 Years
N/A
Open (Enrolling)
Female
Breast Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade 2 and/or 3 fibrosis after radiotherapy

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Lars Stenbygaard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Aalborg Universityhospital

Authority:

Denmark: The Radiotherapy Committee under The Danish Breast Cancer Cooperative Group

Study ID:

DBCG PBI protocol

NCT ID:

NCT00892814

Start Date:

May 2009

Completion Date:

May 2022

Related Keywords:

  • Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma

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