ClinicalTrials.Veeva

Menu

Impact of Radiation Therapy on Breast Conservation in DCIS

Dana-Farber Cancer Institute logo

Dana-Farber Cancer Institute

Status

Completed

Conditions

DCIS

Study type

Observational

Funder types

Other

Identifiers

NCT02248662
12-420
CE-12-11-4173 (Other Grant/Funding Number)

Details and patient eligibility

About

Large regional variation exists in the use of radiotherapy after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast event, many undergo mastectomy instead.

Full description

Patients and their physicians are often confronted with a decision between more intensive versus less intensive treatment for a particular diagnosis. Quality decision-making between these options requires careful balancing of the risks and side-effects, as well as weighing the expected outcomes and their associated value as assessed by the patient.

Although the incidence of DCIS has risen dramatically (1), there exists considerable debate about optimal treatment. In general, people with DCIS have high rates of recurrence-free survival. Intensive therapies for DCIS such as mastectomy (removal of the breast) or radiation therapy following BCS reduce the likelihood of a second breast diagnosis,(2-5) but have not been shown to improve survival.(6) In addition, radiation usually necessitates mastectomy should a new cancer or DCIS develop in the same breast at any point during the patient's lifetime. Patients also have a small chance of experiencing long-term toxicity. Previous radiation can also complicate reconstructive options following mastectomy. The tradeoff between risk of second breast diagnosis and side-effects and potential consequences of radiation therapy underscores the need for patient preference-driven decision making.

Patients who receive BCS alone without radiation therapy may be candidates for repeat BCS if they have a second breast event in the same breast. One study suggests that some women choose not to have radiation after DCIS because they want to preserve a breast-preservation option should a second breast diagnosis occur.(7) However, the likelihood of mastectomy versus BCS at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) Whether a woman receives repeat breast-conserving surgery for a new diagnosis may not only be a function of the stage of diagnosis, but may be also determined by the regional treatment patterns used for management of DCIS. We sought to study whether regional intensity of radiation use for DCIS treatment increases the likelihood of mastectomy at time of second breast event, among women who have not received radiation therapy at initial DCIS diagnosis. (Punglia RS, Cronin AM, Uno H, et al. Association of Regional Intensity of Ductal Carcinoma In Situ Treatment With Likelihood of Breast Preservation. JAMA Oncol. Published online July 21, 2016.)

Enrollment

3,436 patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

This study used data from SEER and SEER-Medicare.

Trial design

3,436 participants in 2 patient groups

Surveillance, Epidemiology, and End Results (SEER) Database
Description:
Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER) with a diagnosis of ductal carcinoma in situ (DCIS) between 1990 and 2011 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis.
Surveillance, Epidemiology, and End Results (SEER)-Medicare
Description:
Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER)-Medicare with a ductal carcinoma in situ (DCIS) diagnosis between 1991 and 2009 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis.

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems