Clinical trial NCT01463007: Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
Official title: ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: invasive ductal cancer
tubular breast cancer
breast cancer
colloid
ER positive
radiation
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: Rhode Island Hospital
First posted: 2011-11-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Early and Intermediate Toxicity
timeFrame: 2 years
Secondary outcomes:
measure: Cosmetic Outcome
timeFrame: 2 years
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: Center For Cancer Care and Research- Watson Clinic
state: Florida
city: Providence
country: United States
facility: Brown University Oncology Research Group
state: Rhode Island
city: Providence
country: United States
facility: Lifespan Hospitals
state: Rhode Island
city: Tacoma
country: United States
facility: Tacoma Radiation
state: Washington
Study officials:
affiliation: Brown University
name: Jaroslaw Hepel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hepel JT, Leonard KL, Sha S, Graves TA, Wiggins DL, Mastras D, Pittier A; Brown University Oncology Research Group; Wazer DE. Phase 2 Trial of Accelerated Partial Breast Irradiation (APBI) Using Noninvasive Image Guided Breast Brachytherapy (NIBB). Int J Radiat Oncol Biol Phys. 2020 Dec 1;108(5):1143-1149. doi: 10.1016/j.ijrobp.2020.07.2312. Epub 2020 Jul 25.
citation: Hepel JT, Hiatt JR, Sha S, Leonard KL, Graves TA, Wiggins DL, Mastras D, Pittier A; Brown University Oncology Research Group; Wazer DE. The rationale, technique, and feasibility of partial breast irradiation using noninvasive image-guided breast brachytherapy. Brachytherapy. 2014 Sep-Oct;13(5):493-501. doi: 10.1016/j.brachy.2014.05.014. Epub 2014 Jul 3.