Partial Breast Irradiation in a Low-risk Population Screened With MRI

Breast Cancer Clinical Trial

Official title:

Image Guided Partial Breast Irradiation (PBL) In A Low-Risk Population Screened With Magnetic Resonance Imaging (MRI)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01255553
• Other study ID #: 09-025-A
• Status: Withdrawn
• Phase: N/A
• First received: November 22, 2010
• Last updated: March 3, 2014
• Start date: June 2009
• Est. completion date: May 2012

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to determine if partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy in patients screened with MRI provides historically similar rates of local failure, limited acute skin toxicity, late complications and cosmetic outcome when compared to patients treated with standard 3D-CRT to the whole breast.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Stage 0 or I breast carcinoma

• 40 years or older

• Post menopausal

• Lumpectomy with clear margins (>2mm)

• Patients with invasive disease must have undergone an axillary staging by axillary dissection (with a minimum of 6 axillary nodes) or sentinal node biopsy

• Gross disease must be unifocal with pathological tumor size 2cm or less

• Target lumpectomy cavity must be clearly marked with surgical clips (the target lumpectomy cavity/whole breast reference volume must be <=30% based on the postoperative imaging)

• Bilateral MRI of the breasts within previous 6 months of radiation therapy (RT) planning

• If patient is eligible based on postoperative imaging, partial breast irradiation (PBI) is judged to be technically deliverable

• Patients with a history of malignancies are eligible if they have stable disease as determined by their attending oncologist

• Patient must have signed the consent form

Exclusion Criteria:

• Men are not eligible

• Patients with Stage II, II, or IV breast cancer

• Pre- or peri-menopausal patients

• Patients with positive lymph nodes

• Patients with suspicious microcalcifications, densities, or palpable abnormalities unless biopsied and found to be benign

• Patients with multifocal, multicentric, or bilateral breast cancer

• Surgical margins that cannot be microscopically assessed or are positive at pathological evaluation

• Patients with a history of breast cancer

• Clear delineation of the extent of the target lumpectomy cavity is not possible

• Breast implants (patients who have had implants removed are eligible)

• Prior breast or thoracic RT for any condition

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Partial Breast Irradiation
Partial breast irradiation will be administered using a 3D conformal external beam RT technique. Two fractions of 38.5 Gy separated by at least 6 hours will be given on 5 treatment days over a period of 5 to 10 days.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving partial breast irradiation (PBI) compared to historical rates of toxicity of patients receiving whole breast irradiation (WBI)		During radiation therapy (5-10 days)	Yes
Primary	Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving PBI compared to historical rates of toxicity of patients receiving WBI		Post therapy (until death)	Yes
Secondary	Survival Rates		5 years	No
Secondary	Cosmetic outcomes of breast PBI	Comparison of cosmetic results (appearance, size, shape, texture, scaring) of breast treated with PBI to untreated breast.	3 years	No