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

NCT01463007 | Completed Results DMC

• 1 other identifier: BrUOG 251
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

invasive ductal cancer; tubular breast cancer; breast cancer; colloid; ER positive; radiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cosmetic Outcome

  2 years

Study Arms (2)

Radiation

EXPERIMENTAL

AccuBoost APBI- 34.0 Gy in 10fx

Radiation: Accelerated partial breast irradiation

Extended Follow up

EXPERIMENTAL

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.

Other: Extended Follow up

Interventions

Accelerated partial breast irradiation RADIATION

Accuboost APBI 34.0 Gy in 10 fractions

Radiation

Extended Follow up OTHER

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.

Extended Follow up

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A confirmed histological diagnosis of invasive breast carcinoma or DCIS
• Age greater or equal to 50 years old
• Life expectancy \> 6 months
• Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy
• Pathologic tumor size less than or equal to 2 cm
• Invasive ductal, mucinous, tubular or colloid histology
• Estrogen receptor positive for invasive carcinoma.
• Unifocal/unicentric disease
• Negative surgical margins greater than or equal to 2 mm
• Pathologic lymph node negative
• No evidence of lymphovascular invasion
• ECOG performance status of 0 or 1 (Appendix 1)
• Informed consent signed.

You may not qualify if:

• Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
• Autoimmune disorder
• Pregnancy
• Breast implants
• Psychiatric or addictive disorder that would preclude attending follow-up
• Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
• Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
• Lobular features on histology (pure or mixed) or sarcoma histology
• Node positive on axillary dissection or in the sentinel lymph node biopsy;
• Extensive in situ carcinoma (EIC)
• Multicentric or multifocal disease
• Paget's disease of the nipple
• Distant metastases
• Lumpectomy cavity not well visualized on AccuBoost imaging
• Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV \> 6cm)

Sponsors & Collaborators

• Jaroslaw Hepel: lead
• The Miriam Hospital: collaborator
• Rhode Island Hospital: collaborator

Study Sites (4)

Center For Cancer Care and Research- Watson Clinic

Lakeland, Florida, 33805, United States

Location

Brown University Oncology Research Group

Providence, Rhode Island, 02903, United States

Location

Lifespan Hospitals

Providence, Rhode Island, 02903, United States

Location

Tacoma Radiation

Tacoma, Washington, 98405-4250, United States

Location

Related Publications (2)

• 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.

  PMID: 32721422 DERIVED

• 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.

  PMID: 24997723 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Jaroslaw Hepel
• Organization: BrUOG-Brown University Oncology Research Group

kristen_mitchell@brown.edu

4018633000

Study Officials

• Jaroslaw Hepel, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: November 1, 2011
• Study Start: August 1, 2011
• Primary Completion: September 12, 2013
• Study Completion: April 6, 2021
• Last Updated: May 19, 2021
• Results First Posted: August 21, 2015

Record last verified: 2021-04

Locations

US (4)