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

Conditions

Breast Carcinoma

Brief 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.

Birgitte Vrou Offersen, Jan Alsner, Hanne Melgaard Nielsen, Erik Jakobsen, Mette Holck Nielsen et al. (15 authors)

Journal of Clinical Oncology2022-08-0574 citations

10.1200/jco.22.00451

Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial.

Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM, IMPORT Trialists.

2017-08-02406 citations

10.1016/s0140-6736(17)31145-5

Interventions

RADIATIONPartial breast irradiation

40 Gy/15 fractions, 3 weeks

RADIATIONWhole breast irradiation

40 Gy/15 fractions, 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

60 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Grade 2 and/or 3 fibrosis after radiotherapy	3 years

Secondary

Measure	Time frame	Description
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival	10 years	morbidity and recurrences

Countries

Denmark

Outcome results

None listed