BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)

Breast Cancer Clinical Trial

Official title:

BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961531
• Other study ID #: 291
• Status: Completed
• Phase: N/A
• Start date: July 24, 2014
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.

Description:

The purpose of this study is to evaluate the rate of early and intermediate toxicity related to accelerated partial breast irradiation (APBI) delivered in a more convenient 5 fraction schedule using non-invasive image-guided breast brachytherapy (NIBB) (AccuBoost System) in women with resected, early stage breast cancer.

Non-invasive image-guided breast brachytherapy (NIBB), using advanced image-guided radiation technology, has the potential to eliminate the disadvantages of the conventional APBI techniques. NIBB facilitates non-invasive partial breast irradiation without the use of catheters or implants. Yet by using breast immobilization and precise image-guidance, it reduces non-target breast tissue within the irradiated field compared with other non-invasive APBI techniques such as 3D-CRT. This has made NIBB an attractive approach to deliver APBI.

We hypothesize that NIBB delivered in 5 treatments will be a more convenient, safe and effective modality to deliver partial breast irradiation.

Anticipated advantages of NIBB protocol treatment include:

• Convenient treatment schedule

• Short course can allow for increased patient access to treatment

• Non-invasive approach

• Increased accuracy with precise targeting of lumpectomy cavity using advanced imaging

• Reduced irradiation of non-target breast tissue

• Reduced skin toxicity

• No heart or lung radiation exposure

• Reduced late skin or breast toxicity

• High rate of good or excellent cosmetic outcome

• High rate of ipsilateral breast tumor control comparable to other APBI techniques

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2021
• Est. primary completion date: October 26, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. A confirmed histological diagnosis of invasive breast carcinoma or DCIS;

2. Age greater or equal to 50 years old;

3. Life expectancy > 6 months;

4. Treated by breast conserving surgery

5. Pathologic lymph node negative, which includes (pN0 i-, i+);

Patients, who are at very low risk for sentinel node involvement and sentinel node biopsy is not performed, are eligible if the treating investigator documents clinically lymph node negative (cN0). These patients include:

• DCIS

• Microinvasion only

• Pure tubular or mucinous histology

• Patients = 70yo with T1a-T1c; estrogen receptor +

6. Pathologic tumor size

1. less than or equal to 2 cm for invasive disease;

2. less than or equal to 3 cm for DCIS;

7. Estrogen receptor positive if invasive disease (DCIS can be ER negative)

8. Negative surgical margins greater than or equal to 2 mm. A margin of <2mm is acceptable if at natural boundary, i.e. skin or pectoralis fascia.

9. No lymphovascular invasion;

10. ECOG performance status of 0-2 (Appendix 1);

11. Informed consent signed.

Exclusion Criteria:

1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)

2. Active lupus or scleraderma;

3. Pregnancy;

4. Psychiatric or addictive disorder that would preclude attending follow-up;

5. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted);

6. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign);

7. pN+ on axillary dissection or in the sentinel lymph node biopsy (N0i+ are considered node negative and are not excluded);

8. Multicentric disease;

9. Paget's disease of the nipple;

10. Breast Implants

11. Distant metastases;

12. Lumpectomy cavity not well visualized on AccuBoost imaging;

13. Lumpectomy cavity with 1cm margin (CTV/PTV) not adequately encompassed by any available applicator.

14. Breast separation with compression > 8cm at time of simulation.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Accuboost APBI
28Gy delivered in 5 daily fractions

Locations

Country	Name	City	State
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Watson Cancer Center	Lakeland	Florida
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Brown University	Cancer Treatment Centers of America, University of California, San Diego, Watson cancer center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Any Toxicity Related to the Radiation Treatment	Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.	during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years
Secondary	Number of Participants With Ipsilateral Breast Local Recurrence		annually for 2 years post treatment