NCT01961531

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

July 24, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2016

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 25, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

October 10, 2013

Results QC Date

January 27, 2020

Last Update Submit

February 23, 2022

Conditions

Breast Cancer

Keywords

DCISIDCInvasive breast carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants With Ipsilateral Breast Local Recurrence

    annually for 2 years post treatment

Study Arms (1)

Accuboost APBI

EXPERIMENTAL

28Gy delivered in 5 daily fractions

Device: Accuboost APBI

Interventions

Accuboost APBIDEVICE

28Gy delivered in 5 daily fractions

Accuboost APBI

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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
  • 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 +
  • Pathologic tumor size
  • less than or equal to 2 cm for invasive disease;
  • less than or equal to 3 cm for DCIS;
  • Estrogen receptor positive if invasive disease (DCIS can be ER negative)
  • 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.
  • +3 more criteria

You may not qualify if:

  • Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
  • Active lupus or scleraderma;
  • Pregnancy;
  • 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);
  • pN+ on axillary dissection or in the sentinel lymph node biopsy (N0i+ are considered node negative and are not excluded);
  • Multicentric disease;
  • Paget's disease of the nipple;
  • Breast Implants
  • Distant metastases;
  • Lumpectomy cavity not well visualized on AccuBoost imaging;
  • Lumpectomy cavity with 1cm margin (CTV/PTV) not adequately encompassed by any available applicator.
  • Breast separation with compression \> 8cm at time of simulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Watson Cancer Center

Lakeland, Florida, 33805, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

Title
Jaroslaw Hepel, MD
Organization
BrUOG- Brown University Oncology Research Group
BrUOG@brown.edu
401-863-3000

Study Officials

  • Jaroslaw Hepel, M.D.

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 11, 2013

Study Start

July 24, 2014

Primary Completion

October 26, 2016

Study Completion

November 30, 2021

Last Updated

March 4, 2022

Results First Posted

August 25, 2020

Record last verified: 2022-02

Locations

US(3)