Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463007
• Other study ID #: BrUOG 251
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: April 6, 2021

Study information

• Verified date: April 2021
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 6, 2021
• Est. primary completion date: September 12, 2013
• 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 with axillary node dissection or sentinel lymph node biopsy

5. Pathologic tumor size less than or equal to 2 cm

6. Invasive ductal, mucinous, tubular or colloid histology

7. Estrogen receptor positive for invasive carcinoma.

8. Unifocal/unicentric disease

9. Negative surgical margins greater than or equal to 2 mm

10. Pathologic lymph node negative

11. No evidence of lymphovascular invasion

12. ECOG performance status of 0 or 1 (Appendix 1)

13. Informed consent signed.

Exclusion Criteria:

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

2. Autoimmune disorder

3. Pregnancy

4. Breast implants

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

6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)

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

8. Lobular features on histology (pure or mixed) or sarcoma histology

9. Node positive on axillary dissection or in the sentinel lymph node biopsy;

10. Extensive in situ carcinoma (EIC)

11. Multicentric or multifocal disease

12. Paget's disease of the nipple

13. Distant metastases

14. Lumpectomy cavity not well visualized on AccuBoost imaging

15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)

16. Breast separation with compression > 7cm.

17. Overlap of skin between orthogonal treatment axes.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Accelerated partial breast irradiation
Accuboost APBI 34.0 Gy in 10 fractions

Other:
• Extended Follow up
This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.

Locations

Country	Name	City	State
United States	Center For Cancer Care and Research- Watson Clinic	Lakeland	Florida
United States	Brown University Oncology Research Group	Providence	Rhode Island
United States	Lifespan Hospitals	Providence	Rhode Island
United States	Tacoma Radiation	Tacoma	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Jaroslaw Hepel	Rhode Island Hospital, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early and Intermediate Toxicity	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 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.	2 years
Secondary	Cosmetic Outcome	Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.	2 years